[Senate Hearing 108-221]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-221
 
              IMPLEMENTATION OF SMALLPOX VACCINATION PLAN
=======================================================================




                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                    JANUARY 29, 2003--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


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                                 senate

                               __________


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                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas                MARY L. LANDRIEU, Louisiana
                    James W. Morhard, Staff Director
                 Lisa Sutherland, Deputy Staff Director
              Terrence E. Sauvain, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho                   DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
TED STEVENS, Alaska                  HERB KOHL, Wisconsin
MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama           MARY L. LANDRIEU, Louisiana
                           Professional Staff
                            Bettilou Taylor
                              Jim Sourwine
                              Mark Laisch
                         Sudip Shrikant Parikh
                             Candice Rogers
                        Ellen Murray (Minority)
                         Erik Fatemi (Minority)
                      Adrienne Hallett (Minority)

                         Administrative Support
                             Carole Geagley














                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening statement of Senator Arlen Specter.......................     1
    Prepared statement...........................................     2
Statement of Julie Gerberding, M.D., M.P.H., Director, Centers 
  for Disease Control and Prevention, Department of Health and 
  Human Services.................................................     2
    Prepared statement...........................................     4
Statement of Anthony Fauci, M.D., Director, National Institute on 
  Allergy and Infectious Diseases, National Institutes of Health, 
  Department of Health and Human Services........................    11
    Prepared statement...........................................    13
Opening statement of Senator Tom Harkin..........................    17
Opening statement of Senator Patty Murray........................    17
    Prepared statement...........................................    17
Opening statement of Senator Mary L. Landrieu....................    25
    Prepared statement...........................................    26
Statement of Brian Strom, M.D., M.P.H. Chair, Institute of 
  Medicine Committee on Smallpox Vaccination, director, Center 
  for Clinical Epidemiology and Biostatistics, University of 
  Pennsylvania...................................................    27
    Prepared statement...........................................    30
Statement of Louis M. Bell, M.D., Chair, Division of Infectious 
  Disease, Children's Hospital of Philadelphia...................    33
    Prepared statement...........................................    35
Statement of Patrick Libbey, executive director, National 
  Association of County and City Health Officials................    37
    Prepared statement...........................................    39
    Statement of Patrick Libbey, executive director, National 
      Association of County and City Health Officials, presented 
      to the Institute of Medicine Committee on Smallpox 
      Vaccination Program Implementation, December 19, 2002......    42
Statement of James August, director, Health and Safety, American 
  Federation of State, County, and Municipal Employees...........    44
    Prepared statement...........................................    46
Statement of Jane Colacecchi, director, Iowa Department of Public 
  Health.........................................................    49
    Prepared statement...........................................    51











              IMPLEMENTATION OF SMALLPOX VACCINATION PLAN

                              ----------                              


                      WEDNESDAY, JANUARY 29, 2003

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:30 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Harkin, Murray, and Landrieu.


               opening statement of senator arlen specter


    Senator Specter. Good morning, everyone. The hour of 9:30 
having arrived, we will begin this hearing of the 
Appropriations Subcommittee on Labor, Health and Human 
Services, and Education. Today we are going to be examining the 
issue of smallpox, the risk which America and the world faces 
from a smallpox bioterrorist attack, and what the risks are on 
inoculation, how well-prepared the United States is to deal 
with this issue, and it is the fourth in a series of hearings 
conducted by this subcommittee.
    Our first hearing on the subject occurred in 1999, before 
9/11, actually on March 16, 1999, to determine the status of 
the Health, Human Services biopreparedness. Then on October 3, 
just 3 weeks after 9/11, a hearing was held on the subject of 
supplemental appropriations, and we were driven out of the Hart 
Building and out of the Dirksen Building, where we are holding 
this hearing, by an anthrax attack, and we had to convene the 
hearing in the bowels of The Capitol, and at that time, we made 
the request of the Center for Disease Control to provide this 
subcommittee with a comprehensive list as to all of the 
potential problems of bioterrorism.
    Two additional hearings have been held since October 3, 
2001. Actually, this is the fourth, and we are joined by our 
companion committee, the authorizing committee on Health, 
Education, Labor, and Pensions, which will be holding a series 
of roundtable discussions on this subject, which is obviously 
of great importance.
    Last night, in the President's State of the Union speech, 
he enumerated a number of bioterrorist potentials from Iraq and 
from Saddam Hussein, and detailed them with some substantial 
specificity, so we know a real problem does exist. We will be 
considering two issues of risk, the issue of risk from attack, 
and the issue of risk from an adverse reaction.

                           prepared statement

    With unanimous consent, a formal opening statement will be 
included in the record.
    [The statement follows:]
              Prepared Statement of Senator Arlen Specter
    This morning, the Subcommittee on Labor, Health and Human services, 
and Education will discuss the issue of bioterrorism-preparedness and 
the implementation of the smallpox vaccination plan. This is the first 
in a series of hearings in the Congress on this subject. As 
appropriators, we will focus on the issues of cost, compensation, and 
safety related to our efforts on smallpox and other biological weapons. 
Tomorrow, the Health, Education, Labor & Pensions Committee will hold a 
complementary roundtable discussion of these issues.
    This is this subcommittee's fourth hearing related to bioterrorism 
preparedness. On October 3, 2001, less than a week before the diagnosis 
of anthrax in a Florida man and the discovery of an anthrax-tainted 
letter in the Senate, we examined these issues. Two weeks later, 
Senator Harkin and I were forced to conduct a follow-up hearing in the 
Capitol as the Senate office buildings were closed due to anthrax 
contamination.
    In fiscal year 2002, over $2.83 billion were appropriated by this 
subcommittee in the effort to prepare our Nation for potential 
biological attacks. Among other things, these funds were to be used to: 
(1) strengthen infrasture at the centers for disease control & 
prevention and State and local health agencies, (2) fund research into 
preventions and treatments for likely agents of bioterrorism, and (3) 
to buy enough smallpox vaccine for every American. Today we will see 
the status of these efforts.
    We have before us this morning, the distinguished directors of two 
key agencies in the defense of our Nation against biological attacks. 
The Centers for Disease Control & Prevention is leading the effort to 
implement the smallpox vaccination plan. The National Institute of 
Allergy & Infectious Diseases is the lead NIH institute on 
bioterrorism-related research. Members of our second panel represent 
groups that will administer the vaccine or be asked to volunteer to be 
vaccinated.
STATEMENT OF JULIE GERBERDING, M.D., M.P.H., DIRECTOR, 
            CENTERS FOR DISEASE CONTROL AND PREVENTION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Senator Specter. At this time, we will turn to our first 
panel, and our lead witness is Dr. Julie L. Gerberding, 
Director of the Centers for Disease Control and Prevention. She 
also serves as associate clinical professor of medicine at 
Emory University, a bachelor and M.D. degree at Case Western in 
Cleveland, and a master in public health from the University of 
California in Berkeley.
    Dr. Gerberding, thank you for joining us, and we look 
forward to your testimony.
    Dr. Gerberding. Thank you. I really do appreciate the 
opportunity to be here to participate.
    Senator Specter. Dr. Gerberding, when you start, let me 
remind you what you have already been told. We try to stick to 
a 5-minute time limit on opening statements. That may seem 
short. I recently was a speaker at Ambassador Annenberg's 
memorial service and got 3 minutes, which is the amount of time 
that former President Ford got and Secretary of State Colin 
Powell got, so I want you to know that a 5-minute allocation 
would be considered in some quarters generous.
    Dr. Gerberding. Generous. Thank you.
    Senator Specter. Let us restart the clock at 5 minutes.
    Dr. Gerberding. Thank you for that. I really appreciate the 
opportunity to be here and to address you and the committee 
about the status of the smallpox preparedness program, and we 
also really thank you and Senator Harkin for the support you 
have given us for the terrorism preparedness. We did 
disseminate $1.1 billion this year to State and local health 
departments and hospitals to assist us in this effort, so 
without your support we would not be where we are today.
    If I can just have the first graphic here, I want to remind 
everyone what we are dealing with and why we are here. Smallpox 
is a deadly and disfiguring disease. It is contagious, and even 
though we had eradicated natural disease from the face of the 
earth, we know that it does pose a threat, that there is a 
possibility of a smallpox attack, and we must take steps to 
prepare our Nation and to protect our public.
    Now, preparedness really consists of four major components. 
We have got to have policies, we have got to have plans, we 
have got to have products such as vaccines and antidotes to the 
side effects, and we have got to have people who are prepared 
and trained to implement the program. I am going to just make a 
few comments about each of those four elements.
    First of all, as you know, the President stated the 
smallpox vaccination policy last December, and he advised 
immunization for the military troops who would be at risk, for 
civilians who would be part of the initial smallpox response 
teams that would manage and take care of the initial cases, and 
for responders and health care workers, who would be at 
occupational risk for exposure should an attack occur.
    The President did not recommend immunization of the 
civilian population at this time, but he did tell us we needed 
to be prepared to find a mechanism to give vaccine to the 
general public for those members of the population who insisted 
upon having it.
    Our planning has progressed rapidly. If I can have the next 
graphic, it just illustrates in very broad terms the state of 
our smallpox preparedness before December of 2002, and the way 
our preparedness looks now. Our States have done a heroic job 
of rising to the occasion and getting funds both for pre-event 
immunization of these response teams as well as plans to ensure 
that we can immunize the entire population in a hurry if we had 
to, should an actual attack occur. So as of today, we have 
approved plans for all 50 States for mass vaccination and plans 
for all 50 States for immunization of the response teams.
    Now, what is the timing of this implementation? If I can 
have the next graphic, I just, in very general terms, want to 
show you how we are going about implementing the program. Over 
on the left-hand side of this, two points. First of all, the 
initial allocation of the appropriation was made in February of 
2002. The remaining 80 percent of the funds, of the $1.1 
billion, was distributed by June.
    In December, the President announced his policy. On January 
24, the State of Connecticut was the first State to initiate in 
a small number of vaccinators the civilian immunization program 
for responders, and what you can see, then, to the left of this 
curve is how we propose to expand this program as safely and as 
efficiently as we possibly can over the next several weeks to 
months.
    Our priority is to immunize the smallpox response teams, 
but as individual States get up to speed and can do this 
safely, they will expand to include the broader group of health 
care workers and first responders who could be at occupational 
risk, and there is no time line for completion but, as I said, 
we are doing this as expeditiously as we safely can.
    As of today, in terms of the products necessary for this, 
the vaccine, we have delivered 98,600 doses of vaccine to 19 
States and Los Angeles County. 35 States and Los Angeles County 
have requested that 187,000 doses of vaccine be delivered in 
the next several days to weeks, so we are working with States 
that have heroically risen to this occasion and really are now 
prepared and approved to receive vaccine and initiate their 
programs.

                           prepared statement

    Finally, let me just conclude with a statement about the 
people involved in this. Their safety is our highest concern, 
and we are engaging in a number of educational programs to 
educate the vaccine volunteers, the vaccinators in the clinics, 
the clinicians around the country, and the general public, and 
we have made many steps to do this, and most notably, I think, 
in the next few days we will be delivering 3\1/2\ million 
information packets to clinicians around the country to ensure 
that they can safely take care of the people and advise them 
about their choice to participate in the program.
    So thank you very much again for the opportunity to be 
here, and I look forward to your questions.
    [The statement follows:]
             Prepared Statement of Dr. Julie L. Gerberding
    Good morning, Mr. Chairman and members of the Committee. I am Dr. 
Julie Gerberding, Director of the Centers for Disease Control and 
Prevention (CDC) and Administrator of the Agency for Toxic Substances 
and Disease Registry (ATSDR).
    Thank you for the opportunity to testify today about the efforts 
underway to assure the nation is prepared in the event of an attack 
using smallpox virus as a weapon.
                              the disease
    Smallpox is a serious, contagious, and sometimes fatal infectious 
disease. There is no specific treatment for smallpox disease. 
Prevention strategies involve vaccination of exposed or potentially 
exposed individuals. Smallpox outbreaks have occurred from time to time 
for thousands of years, but the disease was eradicated after a 
successful worldwide vaccination program. The last case of smallpox in 
the United States was in 1949. The last naturally occurring case in the 
world was in Somalia in 1977.
    Regardless of the mode, magnitude or duration of any terrorist 
attack, smallpox would be expected to spread from person to person 
following its introduction. Much is known about the natural 
transmission of smallpox. Generally, direct and fairly prolonged face-
to-face contact is required to spread smallpox from one person to 
another. Smallpox also can be spread through direct contact with 
infected bodily fluids or contaminated objects, such as bedding or 
clothing. Rarely, smallpox has been spread by virus carried in the air 
in enclosed settings, such as buildings, buses, and trains. Humans are 
the only natural hosts of variola, the virus that causes smallpox. 
Smallpox is not known to be transmitted by insects or animals.
                              the vaccine
    The smallpox vaccine is the only way to prevent smallpox. The 
vaccine is made from a virus called vaccinia, which is another ``pox''-
type virus related to smallpox virus. The vaccine helps the body 
develop immunity to smallpox. It was successfully used to eradicate 
smallpox from the human population. We have had a lot of experience 
with the smallpox vaccine and know it is very effective: it was used to 
eradicate smallpox from the world. It is safe in most people, but in 
some people it is associated with life-threatening adverse events. This 
risk of serious adverse events has made it more difficult to find the 
right balance between preparedness and not placing people at risk 
unnecessarily.
    Routine vaccination of the American public against smallpox stopped 
in 1972 after the disease was eliminated in the United States. 
Vaccination was stopped because the risk of the vaccine was felt to 
outweigh the risk from the disease.
    Until recently, the U.S. Government provided the smallpox vaccine 
only to a few hundred scientists and medical professionals annually who 
work with smallpox and similar viruses in a research setting.
    The stockpiling of smallpox vaccine was an important priority 
before September 11, 2001, and smallpox vaccine was already in 
production at that time. The events of the fall of 2001 heightened 
concern that terrorists may have access to the virus and attempt to use 
it against the American public. In response to these events, the 
Department of Health and Human Services (HHS) increased its order for 
vaccine, accelerated production, and began working to develop a 
detailed plan for the public health response to an outbreak of 
smallpox. The United States currently has sufficient quantities of the 
vaccine for every single person in the country in an emergency 
situation.
                       smallpox response planning
    A single report of a smallpox case in the United States will 
require an aggressive outbreak control effort to contain spread of the 
disease. In partnership with State and Local Health authorities, DHHS/
CDC is in the process of establishing a smallpox preparedness and 
response program that:
  --Enhances community awareness and clinician expertise about smallpox 
        disease and smallpox vaccination through education and 
        training;
  --Performs disease surveillance and laboratory analysis to rapidly 
        detect a single case of smallpox and any subsequent cases;
  --Implements public health interventions, based on careful 
        consideration of epidemiology and mode of transmission of 
        smallpox, in the safest possible manner;
  --Provides vaccination and follow-up service, on a voluntary basis, 
        immediately to those individuals who respond to a smallpox 
        emergency (including, but not limited to, those who will treat 
        the victims, provide security, vaccinate the population, and 
        perform disease case investigations), then, based on knowledge 
        gained, expand the program to include those responders who 
        would be occupationally at risk during a smallpox outbreak;
  --Provides for the capability to rapidly vaccinate a greater number 
        of responders or the entire population should a case occur or 
        threat levels of a possible smallpox terrorist attack increase.
Response to an attack
    States need to be prepared to rapidly implement aggressive smallpox 
containment activities, including the ability to vaccinate their entire 
populations. On October 28, 2002, CDC issued post-event smallpox 
planning guidance to the 50 states; the District of Columbia; the 
commonwealths of Puerto Rico and the Northern Marianas Islands; 
American Samoa; Guam; the U.S. Virgin Islands; the republics of Palau 
and the Marshall Islands; the Federated States of Micronesia; and the 
nation's three largest municipalities (New York, Chicago and Los 
Angeles County). To date, all 62 jurisdictions have developed plans 
that are undergoing review by CDC.
    In addition, we are also working collaboratively with other nations 
(Canada, France, Germany, Italy, Japan, Mexico, and the U.K.) in the 
Global Health Security Action Group (GHSAG) to provide a coordinated 
and collaborative response to a bioterror event. In particular, we are 
working closely with Canada and Mexico, as a smallpox outbreak in 
either could necessitate a rapid response in the United States.
               increasing preparedness prior to an attack
President's plan
    On December 13, 2002, President Bush announced a plan to better 
protect the American people against the threat of smallpox attacks by 
hostile groups or governments. This announcement is a vital step in 
ensuring that we are prepared to respond to a single reported case of 
smallpox. The President's decision will provide the public health and 
emergency response system with a cadre of vaccinated individuals who 
would respond in the event of outbreak of smallpox. The President's 
announcement identified the need for the public health system to 
provide smallpox vaccine to the following:
Smallpox response teams
    HHS has been working with state and local governments to form 
volunteer state and local Smallpox Response Teams that can provide 
critical services to their fellow Americans in the event of a smallpox 
attack. To ensure that Smallpox Response Teams can mobilize immediately 
in an emergency, health care workers and other critical personnel are 
being asked to volunteer to receive the smallpox vaccine. Pre-attack 
vaccination of Smallpox Response Teams will allow them, in the event of 
a smallpox attack, to immediately administer the vaccine to others and 
care for victims. In the initial phase of vaccination, vaccine will be 
offered to core members of public health and health care response 
teams. Then vaccination will expand to include health care workers and 
others who may be first responders.
Department of Defense and State Department personnel
    The President also announced that the Department of Defense (DOD) 
will vaccinate certain military and civilian personnel who are or may 
be deployed in high threat areas. Some United States personnel assigned 
to certain overseas embassies will also be offered vaccination.
Members of the general public
    The Federal Government is not recommending that members of the 
general public be vaccinated at this time. The government has no 
information that a smallpox attack is imminent, and there are 
significant side effects and risks associated with the vaccine. HHS is 
in the process of establishing an orderly process to make unlicensed 
vaccine available to those adult members of the general public without 
medical contraindications who want to be vaccinated either in 2003, 
with an unlicensed vaccine, or in 2004, with a licensed vaccine. A 
member of the general public may also be eligible to volunteer for an 
on-going clinical trial for next generation vaccines.
             implementation of smallpox preparedness plans
    On November 22, 2002, CDC asked states how they intend to vaccinate 
individuals most likely to respond to a smallpox attack. CDC requested 
pre-attack plans that contain information on the number of people 
comprising each Smallpox Response Team, information on where vaccines 
would be administered, the number of health care facilities identified 
to participate, and the number of clinics needed to support this 
effort. States were also asked to address vaccine logistics and 
security, vaccine safety monitoring, training and education, data 
management, and communications in their plans.
Status of State pre-attack vaccination plans
    States have worked diligently to develop plans to vaccinate and 
have begun implementing them. My oral testimony will address the 
current status of their implementation.
    The plans indicate that approximately 450,000 public health and 
healthcare personnel may be offered the smallpox vaccine. Vaccination 
is voluntary and eligible individuals will make their own decisions as 
to whether or not to receive the vaccine. There are no negative 
ramifications employment ramifications for anyone who chooses not to be 
vaccinated. About 1,500 clinics around the nation will be set up to 
deliver the vaccine to those who choose to receive it. In addition, 
state health officials have identified over 3,300 health care 
facilities that will participate in the program.
                   distributing vaccine to the states
    The National Pharmaceutical Stockpile (NPS) Program ensures the 
availability and rapid deployment of life-saving pharmaceuticals, 
antidotes, other medical supplies, and equipment necessary to counter 
the effects of nerve agents, biological pathogens, and chemical agents. 
The NPS Program stands ready for immediate deployment to any U.S. 
location in the event of a terrorist attack using a biological toxin, 
chemical or radiological agent directed against a civilian population 
at the request of the locality.
    The week of January 20, 2003, CDC delivered kits with enough 
vaccine and needles for 21,600 public health and healthcare workers to 
Connecticut, Nebraska, Vermont and Los Angeles County. As of January 
22, 2003, 20 states (including 1 county) requested nearly 100,000 doses 
of vaccine. These were the first shipment of vaccine to state and local 
governments under the President's plan to protect the American people 
from an intentional release of the smallpox virus. Under the program, 
smallpox vaccine is being offered to those most likely to respond to a 
potential outbreak of the disease. Each state notifies CDC when it is 
ready to receive its shipment of smallpox vaccine to begin pre-event 
vaccination of public health and healthcare workers. Once CDC receives 
a request for smallpox vaccine from a state, the order is forwarded to 
the National Pharmaceutical Stockpile for processing and shipment. CDC 
is providing smallpox handling instructions, cold chain management 
guidance, and all appropriate documentation. CDC will deliver 
DryvaxTM smallpox vaccine, packaged and shipped in 
increments as small as one vial (100 doses). CDC will validate all 
delivery information prior to shipment and will release vaccine after 
validation of temperature monitoring information.
                         training and education
    Because smallpox vaccine has not been used routinely in the United 
States since the early 1970s, many of today's healthcare providers are 
not familiar with the disease, the vaccine, or the vaccine's potential 
side effects. This makes training of those administering and those 
receiving the vaccine necessary to ensure that this program is 
implemented as safely as possible. Anyone considering vaccination must 
receive information on conditions that are contraindications to 
vaccination (e.g., certain skin conditions, compromised immune systems, 
pregnancy, allergies to components of the vaccine, or household 
contacts with a condition listed above). CDC has held 19 training and 
education sessions on smallpox that reached an estimated 800,000 
clinicians, members of the public health workforce, and members of the 
general population. Training has been conducted in classrooms, via 
satellite, over the Internet, through videotaped sessions and CD-ROM, 
and over the telephone. Thirty different training products, in a wide 
variety of media formats, currently are available.
Training for response team members
    Training and education for Smallpox Response Team members will be 
critical. In order to prepare for their participation in a smallpox 
response effort, all Smallpox Response Team vaccination candidates will 
be asked to watch a video distributed by CDC and will receive a packet 
of information describing the purpose of the national smallpox 
preparedness program. The response team members will receive general 
information about smallpox disease and the vaccine, including pre- and 
post-vaccination worksheets to provide instructions for anticipating 
and monitoring any potential side effects, as well as fact sheets on 
various methods of treatment for side effects resulting from 
vaccination. Prior to vaccination, each vaccine recipient will be 
required to fill out a patient medical history and consent form to 
confirm the absence of contraindications and to confirm the patient's 
consent in receiving the vaccine.
Training for clinicians
    Clinicians must be able to detect the first symptoms of a potential 
case of smallpox. During vaccination of response team members, 
clinicians will be an important resource for volunteers who are making 
a decision about whether or not they want to accept the smallpox 
vaccine. CDC has an ongoing initiative to educate clinicians about 
smallpox, done in conjunction with experts from a variety of medical 
professional organizations, including the Infectious Disease Society of 
America, the American Academy of Dermatology, the American College of 
Emergency Medicine (within a consortium of other emergency clinician 
organizations), and several primary care organizations. We are planning 
to help these organizations repackage information from CDC, and 
distribute it to their constituents in the format most appropriate for 
their members. In addition, CDC has established ongoing communication 
with 66 professional organizations that represent front-line clinicians 
to determine the smallpox training and education needs of their 
members. Within the next month, CDC is planning a national mail-out of 
critical clinician information to the nation's hospital and clinical 
community through each state's licensing board. In addition, we 
anticipate hundreds of thousands of clinicians will participate in 
CDC's upcoming Public Health Training Network program on ``Clinical 
Management of Adverse Events Following Smallpox Vaccination: A National 
Training Initiative'' scheduled for February 4, 2003. To supplement 
this extensive campaign to educate clinicians, CDC is also utilizing 
its normal means of getting information to clinicians, including the 
Health Alert Network, the secure Epi-X program, and the Morbidity and 
Mortality Weekly Report (MMWR). CDC has also contracted to establish a 
24-hour-a-day, 7-day-a-week hotline for clinicians to call with 
questions about smallpox vaccinations.
Training for laboratorians
    CDC is providing smallpox training for laboratorians, including 
detailed instructions on the differentiation of smallpox from other 
rashes. On January 29, 2003, CDC will broadcast nationally a training 
program entitled, ``Smallpox and Vaccinia Laboratory Testing: A 
National Training Initiative.'' The program presents detailed 
information, specific to those who perform testing and those who use 
laboratory services, such as physicians, nurses, epidemiologists, and 
state medical officers. They will also be given specific information on 
the laboratory role in diagnosing adverse events associated with 
smallpox vaccination. In addition, CDC has developed ``Agents of 
Bioterrorism: A Guide for Clinical Laboratories,'' which includes 
information for clinical laboratorians about handling specimens 
suspected of containing smallpox. This guide will be distributed to the 
state public health laboratories within the next two weeks. The state 
public health laboratories can customize the guide with state-specific 
information and deliver it to the clinical laboratories in their area.
Education for the public and the media
    CDC has, and will continue to use, weekly (and as warranted) media 
briefings, media advisories, access to smallpox vaccine experts, and 
public information materials to create awareness of the smallpox 
vaccination recommendations, the purpose of the recommendations, and 
the risks associated with smallpox vaccine. In addition, CDC is using 
its website to provide easy access to a wide range of smallpox 
education materials, including materials designed specifically to meet 
the needs of different audiences--such as members of the public, health 
care providers, people for whom smallpox vaccination is recommended, 
and state and local health departments. We have been, and will continue 
to work with, state and local health departments and other partners to 
help ensure our messages and materials are visible and readily 
available. CDC also operates a 24-hour-a-day, 7-day-a-week public 
information hotline that is accessible in English and Spanish.
    preventing, diagnosing, treating, and monitoring adverse events
    Ensuring that we can implement this program as safely as possible 
has been central to our planning. The first part of this effort is to 
carefully educate and screen those considering vaccination. We have had 
a great deal of experience with this vaccine and have information on 
who is at risk of serious adverse events (e.g., those who have certain 
skin conditions, have compromised immune systems, are pregnant, have 
allergies to components of the vaccine, or have a member of their 
household with a condition listed above). Second, we will, with state 
and local health departments and the healthcare community, ensure that 
we diagnose, manage, and treat adverse events promptly and correctly. 
Third, we will very carefully monitor adverse events to ensure that we 
know of any unexpected patterns or types of adverse events on a real-
time basis and can quickly modify the program to decrease the risk of 
adverse events if necessary. Included in this effort is education about 
what to expect after vaccination, when to be concerned about an adverse 
event, and where to go for help.
    The Smallpox Vaccine Adverse Events Monitoring and Response System 
will monitor the occurrence of clinically significant, especially 
serious, adverse events (AEs). It will also serve to identify any 
unexpected adverse events. This process will help to build state 
capacity for assessment of adverse events.
Diagnosing and treating adverse events
    CDC will provide technical assistance to state health departments, 
including screening to identify and exclude persons with 
contraindications and help in implementing proper clinical procedures. 
There will be a designated telephone hotline for state health 
departments. CDC will monitor state tracking of clinically significant 
AEs. CDC will also inform states of any adverse event reports 
transmitted directly to CDC.
    Efforts are underway to work with healthcare providers to assure 
they are educated about the smallpox vaccination program and smallpox 
vaccine AEs. This includes recognizing possible AEs and managing and 
treating any AEs among their patients. Standard algorithms are under 
development to assist physicians in proper identification and treatment 
of these patients.
    Vaccinia Immune Globulin (VIG) is a product used to treat certain 
serious adverse reactions caused by smallpox vaccine. Sufficient 
quantities of VIG are available now to treat all anticipated adverse 
events resulting from the current vaccination program. New VIG is being 
produced and delivered to the National Pharmaceutical Stockpile for 
distribution, if needed, as the vaccination program expands. An effort 
is underway to produce new lots that will meet the standards for 
intravenous immune globulin. Cidofovir is a drug used to treat viral 
infections in persons with HIV/AIDS. It may be helpful in treating 
vaccinia reactions in cases where VIG does not work.
    The state will inform CDC of VIG and/or Cidofovir requests. A CDC 
clinical team will then assess the request with the state and treating 
physician. CDC Drug Services and the National Pharmaceutical Stockpile 
will coordinate release of VIG and Cidofovir. The treating physician 
will then designated as a co-investigator on the Investigational New 
Drug (IND) protocol.
Reporting
    CDC is working with the states to develop an active surveillance 
system to detect serious adverse events following smallpox vaccine. CDC 
intends to implement recommendations that all health care workers have 
their vaccination sites monitored in the hospital daily, which will 
contribute information on serious illnesses that occur in all 
vaccinees. In addition, CDC will use the Vaccine Adverse Event 
Reporting System (VAERS), a national surveillance system administered 
by CDC and the Food and Drug Administration (FDA), to monitor smallpox 
AEs. The data collected through VAERS will be analyzed to identify any 
new or rare vaccine side effects, increases in rates of known side 
effects, associations with specific vaccine lots, or patient risk 
factors.
Post-vaccination surveillance
    Post-vaccination surveillance will be conducted for people 
receiving the smallpox vaccine. This surveillance will assist in 
determining the rates of common AEs, assessing impact on time lost from 
work, and evaluating vaccinee satisfaction with the immunization 
program. This will be done by telephone survey 10 and 21 days post-
vaccination.
Data and safety monitoring board
    CDC has established a Data and Safety Monitoring Board to provide 
advice to the CDC and program managers on selected aspects of pre-event 
smallpox vaccination program implementation.
    The committee will review reported adverse events to determine 
whether rates of serious events are within expected limits; whether 
recommendations for screening out persons with contraindications are 
being properly observed; whether adverse events following vaccination 
are causally or only coincidentally linked to vaccination; and whether 
the adverse events experienced necessitate a substantial change in the 
way the program is run.
                             iom committee
    Through the Institute of Medicine's (IOM) Committee on Smallpox 
Vaccination Program Implementation, the IOM is providing advice to the 
CDC and program managers on selected aspects of pre-event smallpox 
vaccination program implementation. The IOM Committee released its 
first report on January 17, 2003.
    The committee is making recommendations to CDC and state and local 
vaccine program managers to improve: CDC guidance designed to identify 
potential vaccine recipients at high risk of vaccine adverse events and 
complications; CDC measures to ensure the early recognition, 
evaluation, and appropriate treatment of adverse events and 
complications of smallpox vaccination; CDC plans for collecting and 
analyzing data on vaccine immunogenicity, adverse events, 
complications, and vaccine coverage; the informed consent process for 
vaccine recipients; professional education and training materials; 
communication plans for public health and medical professionals and the 
public; state smallpox vaccination implementation plans; and the 
achievement of overall goals of the smallpox vaccination program (e.g., 
vaccine coverage rate, equity of access, adverse reaction rates, etc.).
                               conclusion
    Assuring the nation is prepared in the event of an attack by a 
hostile group or government is one of the highest priorities for the 
administration. HHS and CDC are dedicated to assisting the states in 
increasing smallpox preparedness. We greatly appreciate all the work 
the states and local jurisdictions have done to develop plans and begin 
to implement them. We look forward to continuing to support states' 
efforts to protect the American people.
    Thank you for the opportunity to testify before you today on this 
important public health issue. I would be happy to answer any of your 
questions.

    Senator Specter. Thank you very much, Dr. Gerberding. Just 
a few questions before turning to Dr. Fauci. You commented 
about, in excess of $1 billion being distributed. This 
subcommittee had urged a very substantial funding after 9/11, 
and that was an outgrowth of the October hearing which we had, 
so that we had close to $3 billion in the supplemental 
appropriations bill.
    The Center for Disease Control has been in urgent need of 
repairs for many, many years, and it was only when this 
subcommittee made a site inspection 2\1/2\ years ago that we 
found out how deplorable the situation was, and in advance of 
9/11 this subcommittee took the lead in putting up $170 million 
to renovate the CDC.
    We saw, I personally saw a deplorable situation, with 
distinguished scientists in quarters and with potentially toxic 
substance without adequate security, and to have a facility 
like the Center for Disease Control in that situation was just 
really astounding. And then the following year, we put up some 
$255 million. We are on a path to reach in excess of $1 billion 
to renovate the Center for Disease Control.
    This subcommittee has been very, very attentive to medical 
research and the kinds of issues which you face. Senator Harkin 
and I have taken the lead on this subcommittee to double the 
NIH funding, so that it started out at about $12 billion in 
fiscal year 1996, and with this year's appropriation, we will 
exceed $27 billion, so it is very important that this 
subcommittee be informed as to the specifics as to what you 
need.
    Now, you say that you have distributed $1.1 billion at the 
present time?
    Dr. Gerberding. That is correct.
    Senator Specter. And what is the basis for that 
distribution? How do you decide who gets what?
    Dr. Gerberding. This year, the appropriation was divided 
into the $918 million that went to health care, or to the State 
and local health departments, and the remainder went for 
hospital preparedness and the health care facilities.
    Senator Specter. $918 million went to State and local----
    Dr. Gerberding. State and local health agencies.
    Senator Specter [continuing]. Health agencies.
    Dr. Gerberding. 50 States, four metropolitan areas, and 
then several islands that are sovereign and need their 
independent appropriations. Altogether, there are 62 
jurisdictions.
    Senator Specter. 62 jurisdictions? How far does $918 
million go?
    Dr. Gerberding. Well, it has certainly taken us further 
than we were the year before we got it. What we have asked the 
health departments to do is to address 16 critical capacities 
that deal with preparedness for terrorism as well as other 
public health threats and emergencies.
    That includes the kind of planning and program 
implementation that I discussed. It includes rehabilitation of 
laboratory facilities, which were in dreadful shape in many 
jurisdictions. It includes the national pharmaceutical 
stockpile logistics, so that people can deliver and utilize the 
measures we have in the stockpile, and it includes provision 
for communication, alerting, training and overall preparedness 
of the clinician community.
    Senator Specter. On Monday, the day before yesterday, 
Senator Santorum and I visited UPMC, the University of 
Pittsburgh Medical Center, and we observed a facility which 
they have set up for decontamination, and the University of 
Pittsburgh Medical Center has undertaken this on their own, on 
their own financing. They are seeking what we call an earmark 
from this subcommittee, but obviously the principal line of 
funding is going to have to come from the new Department of 
Homeland Defense, where there is some $38 billion allocated.
    Now, admittedly, that has to cover a lot of lines, but I 
would like to have your evaluation as a follow-up to this 
hearing, Dr. Gerberding, as to what it is going to take to 
adequately fund State and local facilities. Wherever I go in my 
State, and it is just one State, I hear concerns about the 
adequacy of funding, and people are going to be going to the 
hospitals, and our public health infrastructure admittedly has 
been in a sad state.
    Let the record show the witness is nodding. Now the witness 
is smiling.
    Dr. Gerberding. The witness is in complete agreement.
    Senator Specter. It is a very tough issue, but we have to 
know the hard facts. You have got to tell us what it is going 
to take. This subcommittee has demonstrated in the past our 
capacity to provide what it takes, and I know the President is 
committed to this, but you professionals are going to have to 
tell us, and very candidly, for a long time we did not hear 
from the Centers for Disease Control about what you needed, and 
it was only when we went to Atlanta that we found out, and you 
have got to tell us what you need.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL 
            INSTITUTE ON ALLERGY AND INFECTIOUS 
            DISEASES, NATIONAL INSTITUTES OF HEALTH, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Senator Specter. Dr. Fauci, we welcome you back to this 
subcommittee. You are a regular.
    Dr. Anthony S. Fauci, Director of the National Institute of 
Allergy and Infectious Diseases, with the National Institutes 
of Health, came to the NIH in 1860--1968--
    Dr. Fauci. It seems that way.
    Senator Specter. You have been there almost as long as I 
have been in elective office, Dr. Fauci--after completing his 
residency at the New York Hospital/Cornell Medical Center, a 
native of Brooklyn, M.D. degree from Cornell University Medical 
College.
    Dr. Fauci and I had a lively discussion a few months ago 
about inoculations and who ought to bear the risk, and I took 
the position that parents, maybe even grandparents ought to 
make decisions. I did not want the Government to make a 
decision for my four grandchildren, and after a while, I think 
you agreed with me, Dr. Fauci.
    Dr. Fauci. Yes.
    Senator Specter. We thank you for the very distinguished 
work you have done. We welcome you here and look forward to 
your testimony.
    Dr. Fauci. Thank you, Mr. Chairman. It is a pleasure to be 
here testifying to you and this committee once again on this 
important subject.
    Dr. Gerberding has mentioned the horror of smallpox as a 
disease, so I will not spend more time on that, except to say 
in the context of my main theme, namely vaccination, that this 
devastating disease has shaped civilizations, killing more than 
500 million people over the years, a fatal disease in 30 
percent of cases, no treatment available. However, a vaccine 
that has been used now for decades and decades has been 
responsible for the eradication of smallpox in this country and 
worldwide.
    The vaccine that was used in this country and was put into 
storage is what we call Dryvax. As you know, I testified before 
this committee, where we had 15 million in storage. That 
vaccine is greater than 95 percent effective, and in studies I 
reported to this committee sometime ago, we showed that, 
despite decades of storage, it not only maintained its full 
potency and take rate, but it also could be diluted 1-to-5. We 
will be using the undiluted Dryvax vaccine on the program that 
Dr. Gerberding described.
    With regard to the adverse effects, these are the numbers 
that have been gathered from the 1968 cohort. For every million 
people vaccinated, there will be 14 to 52 serious life-
threatening events. There will be 49 to 935 serious but not 
life-threatening, and one to two deaths per million. These are 
for primary vaccinees. People who have already been vaccinated 
have a considerably lower incidence of adverse events 
associated with this vaccine.
    What do we do with adverse events when they are serious 
enough? We have a standard methodology for approaching. One of 
them is what we call Vaccinia Immune Globulin, which is derived 
from the plasma of people who have been vaccinated. It is an 
antibody that can block the Vaccinia vaccine. We currently have 
enough now to cover all the possible projected adverse events 
that we would see in the program that Dr. Gerberding described, 
and by the summer, we will have enough to cover over 300 
million vaccinees.
    We also have an experimental product, Sodopavir, which was 
originally used against sodomegaler virus, which is now in an 
IND, shown to be effective in animal models against smallpox.
    Senator Specter. Dr. Fauci, when you now say you have 
enough to cover all of the adverse effects, quantitatively what 
do you mean?
    Dr. Fauci. We mean that if you use the projections we 
showed here of what you might expect per million people 
vaccinated, the program that Dr. Gerberding described would 
give you a projected amount that you might see within a bracket 
of the lower limit and the upper limit. We now have enough 
Vaccinia Immune Globulin within our stores that we could handle 
the response and the therapeutic approach to essentially those 
numbers of adverse events.
    So remember, we were discussing months ago, do we have 
enough VIG, as we call it? The answer right now is yes, we have 
enough now, and we are making more, so that by the summer we 
will have enough so that if we have to vaccinate 300 million 
people we will have enough.
    Senator Specter. Thank you.
    Dr. Fauci. You are welcome. We are striving for something 
very important, and that is an attenuated vaccine that would 
obviate this concern about toxicity. One of the ones we are 
working on is Modified Vaccinia Ankara, which is a modification 
of the vaccinia. It is attenuated. Experience in the field 
shows that they have very, very few toxic side effects and 
adverse events. We are rapidly pushing this to the point of 
being able to have enough to use, and that will likely happen 
within the next couple of years. There is also another 
attenuated strain that the Japanese use.
    I am going to spend the last minute just very quickly 
reviewing the other types of countermeasures that we have, not 
only for smallpox, but for other agents. I presented our 
strategic plan and our category A research agenda to this 
committee last year. We now have completed and have published 
the research agenda for category B and C pathogens.
    All of this is anchored on the concept that we will use the 
basic research agenda that is tried and true and tested at the 
NIH, but the shift of the paradigm will be a much greater 
emphasis on the translation of that basic research into new, 
definable product countermeasures such as diagnostics, 
therapeutics, and vaccines. Obviously, this will require close 
collaboration with academia, and particularly with our 
industrial partners.
    Then finally, on this last slide, I talk about what we 
would say, the preparedness from a research standpoint. To 
compliment the preparedness that Dr. Gerberding spoke about 
from a public health standpoint is the vision of the future, to 
be able to have universal antibiotics and antivirals that could 
be used against multiple agents, safe and effective new 
generation vaccines, as well as advances in our capability of 
modulating the immune system and, finally, molecularly based 
diagnostics.

                           prepared statement

    At the end of the day, this will have two purposes. One, I 
believe it will effectively defend us against agents of 
bioterror, but also what it would do, it would serve as well to 
be able to defend the population of this country and the world 
against naturally occurring emerging and reemerging microbes.
    Thank you. We would be happy to answer any questions you 
have.
    [The statement follows:]
               Prepared Statement of Dr. Anthony S. Fauci
    Mr. Chairman and Members of the Committee, thank you for inviting 
me here today to discuss the implementation of the President's smallpox 
vaccination plan, which is intended to protect the American people 
against the threat of a smallpox attack. Because of the long-standing 
expertise of the National Institute of Allergy and Infectious Diseases 
(NIAID) of the National Institutes of Health (NIH) in biomedical 
research on emerging and reemerging infectious diseases, including 
smallpox and other potential bioterror agents, the Institute has been 
designated by President Bush to play a leading role in the nation's 
fight against bioterrorism. As Director of the NIAID, I am committed to 
bringing all of our research expertise to bear on the full 
implementation of this important effort.
                   smallpox vaccine implemention plan
    On December 13, 2002, the President announced a plan to prepare and 
protect the American people against the threat of a possible smallpox 
attack by hostile groups or governments. Under the plan, the Department 
of Health and Human Services (DHHS), through the Centers for Disease 
Control and Prevention (CDC), will work with state and local 
governments to form volunteer ``Smallpox Response Teams'' who can 
provide critical services to their fellow Americans in the event of a 
smallpox attack. To ensure that these teams can mobilize and perform 
effectively in an emergency, it is recommended that health care workers 
and other critical personnel volunteer to receive the smallpox vaccine. 
The President also announced that the Department of Defense will 
vaccinate certain military and civilian personnel who are or may be 
deployed in high threat areas. Some U.S. personnel assigned to certain 
overseas embassies also will be offered vaccination. It should be noted 
that the Federal government is not recommending vaccination for the 
general public at this time.
                         smallpox--the disease
    Smallpox is a serious, contagious, and sometimes fatal disease. The 
symptoms of smallpox infection appear approximately 12 to 14 days 
(range: 7 to 17 days) following exposure. Initial symptoms include high 
fever, fatigue, and head and back aches. A characteristic rash, most 
prominent on the face, arms, and legs, follows in 2-3 days. The rash 
starts with flat red lesions (a ``maculopapular'' rash) all beginning 
at the same time. These lesions become pus-filled and begin to crust, 
forming scabs that separate and fall off after about 3-4 weeks. 
Individuals are generally infectious to others from the time period 
immediately prior to the eruption of the maculopapular rash until the 
time of the shedding of scabs, but are most infectious during the first 
7 to 10 days of rash. The mortality of smallpox infection is 
approximately 30 percent, although mortality is likely to be much 
higher in those with compromised immunity, such as individuals with HIV 
infection and those receiving cancer therapies or drugs to prevent the 
rejection of transplanted organs. Smallpox patients who recover 
frequently have disfiguring scars over large areas of their body, 
especially their face; some are left blind. There is no licensed 
treatment for smallpox disease, and the only known prevention is 
vaccination.
    A massive vaccination program led by the World Health Organization 
(WHO) eradicated all known smallpox disease from the world in the late 
1970's, a resounding success story for vaccination and public health. 
The last case of smallpox in the United States of America was in 1949, 
and use of the vaccine in this country was discontinued in 1972. In 
1980, WHO recommended that all countries stop vaccinating for smallpox. 
At the present time, small quantities of smallpox virus are stored in 
two secure facilities in the United States and Russia explicitly for 
research purposes, but it is believed that unrecognized stores of 
smallpox virus exist elsewhere in the world.
    Prior to its eradication, smallpox was considered one of the most 
devastating infectious diseases known to mankind. Today, with the real 
possibility that smallpox may be used as an agent of bioterrorism, it 
may be once again poised to threaten public health worldwide.
                         smallpox--the vaccine
    The ``Smallpox Response Teams'' and ``first responders'' identified 
in the President's Smallpox Vaccination Plan will receive FDA-licensed 
Dryvax smallpox vaccine in the undiluted form. This vaccine was made by 
Wyeth Laboratories and approximately 15 million doses have been in 
storage since 1982, when the company stopped making the vaccine. 
Historically, Dryvax smallpox vaccine has proven to be 95 percent 
effective in preventing smallpox infection. In unvaccinated people 
exposed to smallpox, the vaccine can lessen the severity of, or even 
prevent, illness if given within 3 days after exposure.
    The vaccine is freeze-dried, live vaccinia virus, a poxvirus 
related to smallpox virus--it is not a dead virus like many other 
vaccines. The vaccine is delivered in an unusual way, using a technique 
called scarification whereby the material is pricked into the skin 
using a two-pronged needle. Successful vaccination is measured by the 
development of a clear-cut pustule 6-8 days after vaccination. This is 
known as a ``take.'' The blister dries up and a scab begins to form, 
and by the third week the scab falls off, leaving a scar. The 
immunization site remains contagious for vaccinia until the scab dries 
up completely and falls off. For that reason, the vaccination site must 
be cared for carefully to prevent the virus from spreading. 
Approximately one week after vaccination, many people experience fever, 
malaise, myalgia, soreness at the vaccination site, and swelling of the 
lymph nodes in the area of the vaccine, particularly under the arms.
    In order to determine whether the existing supply of Dryvax vaccine 
(15 million doses) retained its potency and could even be diluted to 
expand the stock, a series of clinical trials were performed. In this 
regard, NIAID conducted a study on adults who had not been previously 
vaccinated to determine whether Dryvax could be diluted effectively to 
make more doses of this smallpox vaccine available. This clinical trial 
showed that the existing U.S. supply of smallpox vaccine was still very 
potent in its undiluted form and could be diluted five-fold and retain 
its potency, effectively expanding the number of doses of smallpox 
vaccine in the United States to 75 million. A report describing these 
findings appeared in the April 25, 2002, issue of The New England 
Journal of Medicine. The Dryvax vaccine also is being studied by NIAID 
in previously vaccinated populations to determine whether any residual 
immunity exists from earlier vaccinations.
    In addition to Dryvax, NIAID is sponsoring clinical trials of 
another vaccine against smallpox developed by Aventis Pasteur. Eighty 
million doses of Aventis Pasteur's smallpox vaccine, a different 
formulation of the vaccinia smallpox vaccine, have been in storage for 
40 years. NIAID-supported studies performed through its Vaccine 
Treatment and Evaluation Units will determine the safety and 
preliminary efficacy of various concentrations of Aventis Pasteur's 
smallpox vaccine in adults. To further ensure adequate supplies of 
smallpox vaccine, DHHS has contracted with Acambis, Inc. to produce a 
cell culture based smallpox vaccine for licensure.
        smallpox vaccine research--challenges and opportunities
    While the Dryvax smallpox vaccine is currently the most effective 
weapon against a possible smallpox attack, it still poses risks, even 
in healthy populations. Fortunately, most individuals experience only 
mild symptoms. However, serious reactions to smallpox vaccination are 
well documented in studies dating back to the 1960s when smallpox 
vaccination was routine in the United States. Those data indicate that, 
for every 1 million people vaccinated, there are 14 to 52 life-
threatening adverse events such as post-vaccinial encephalitis with 1 
to 2 deaths. In addition, there are 49 to 935 serious, but not life-
threatening events. Moreover, because smallpox vaccination ceased in 
the United States more than 25 years ago, there is limited experience 
with this vaccine in the era of HIV infection, organ transplantation, 
and immunosuppressive therapy.
    The protection of all populations, including immunocompromised 
individuals, pregnant women, and children is the next critical 
important step in addressing the smallpox threat. NIAID is carefully 
examining alternatives to Dryvax including modified vaccinia Ankara 
(MVA), which may be a viable ``second generation'' smallpox vaccine for 
individuals at high risk of complications from the current Dryvax 
smallpox vaccine.
    Several of the complications of smallpox vaccination can be treated 
with Vaccinia Immune Globulin (VIG), which is derived from the plasma 
of volunteers who previously have received a smallpox vaccination. DHHS 
currently has more than enough VIG to cover the adverse events that are 
projected to be associated with vaccinating the smallpox response teams 
and first responders under the President's smallpox vaccination plan. 
Furthermore, the CDC has contracted for additional supplies of VIG to 
ensure an adequate stockpile of this product by this summer to cover 
the severe adverse events that might be expected for over 300 million 
vaccinees.
    Assessments of MVA vaccine candidates in multiple animal models, 
including immunosuppressed animals, are providing important data on the 
safety and efficacy of the vaccine. In addition, historical data from 
people who received an MVA vaccine in Germany in the 1970's adds to the 
body of scientific data. Importantly, the clinical trials conducted in 
Germany at the time included children, who are known to be at risk for 
adverse events associated with the conventional vaccinia-based vaccine. 
MVA vaccine also has been tested recently as an experimental vaccine 
vector for the delivery of other vaccine candidates, including HIV and 
cancer vaccines. These studies suggest that the vaccine may be safe in 
immunocompromised individuals.
    In late 2002, the NIAID issued a Request for Proposals (RFPs) 
intended to provide resources for the initial development of MVA 
vaccine candidates. NIAID intends to issue a second RFP during the 
summer of 2003, entitled ``Production and Acquisition of MVA Vaccine.'' 
The objective of the second RFP will be to manufacture, formulate, fill 
and finish, and test, in accordance with current Good Manufacturing 
Processes (cGMP) regulations, up to 30 million doses of MVA vaccine to 
constitute the U.S. Government's stockpile for emergency use under 
Investigational New Drug (IND) status and to provide a licensure plan 
to include the conduct of expanded human safety studies required for 
licensure and the conduct of pivotal animal protection studies. A third 
contract solicitation for the acquisition of a licensed product is 
being planned for 2005, under the auspices of the CDC.
    In addition, the NIAID Vaccine Research Center on the NIH campus in 
Bethesda, MD, is conducting a clinical trial to determine the safety of 
MVA and to compare the immunogenicity of MVA and Dryvax. This study is 
being conducted in healthy volunteers who have not been previously 
immunized with vaccinia; a future trial with vaccinia-experienced 
subjects is being planned. NIAID also is looking ahead to develop 
``third'' generation smallpox vaccines, including recombinant protein 
vaccines.
    NIAID is also evaluating drugs for use against smallpox virus. 
NIAID-supported scientists have developed a form of the antiviral drug 
cidofovir that can be administered orally. Injectable cidofovir already 
has been approved by the Food and Drug Administration (FDA) for 
treating CMV retinitis in individuals with HIV/AIDS and has shown 
activity against smallpox and related viruses in laboratory and animal 
studies. Preliminary data from these experiments suggest that cidofovir 
may be helpful in controlling the progression of serious vaccinia-
related complications. To illuminate this issue, NIAID worked last year 
with colleagues at the CDC, the FDA and the Department of Defense (DOD) 
to develop an Investigational New Drug application to evaluate 
cidofovir in the treatment of smallpox. NIAID continues to explore the 
development of additional therapeutic interventions against smallpox 
and other potential bioterror agents.
                          biodefense research
    Smallpox is only one of a number of potential bioterror threats to 
our nation. In 2002, NIAID convened two Blue Ribbon Panels to provide 
objective scientific advice on NIAID's biodefense research activities 
involving smallpox as well as other potential agents of bioterror. As a 
result of these deliberations, the Institute has developed two research 
agendas: one focuses on the CDC's Category A agents, which include 
smallpox, while the second focuses on NIAID's Category B and C Priority 
Pathogens. Guided by the recommendations outlined in these agendas, 
NIAID developed a total of 52 biodefense initiatives to stimulate 
research in fiscal years 2002 and 2003; 36 are new initiatives and 16 
are significant expansions. During this same time period, NIAID has 
seen a 30 percent increase in the number of grant applications; the 
vast majority of these are in response to our biodefense initiatives.
    In fiscal year 2002, several NIAID initiatives encouraged industry 
partnerships and focused on the development of new diagnostics, 
vaccines and therapeutics for CDC Category A agents. These types of 
research initiatives have been well received. As a result, NIAID has 
expanded and reissued many of these collaborative efforts in fiscal 
year 2003, and plans to do the same in fiscal year 2004. In addition, 
the new initiatives will be broadened to address NIAID's Category B and 
C Priority Pathogens.
    A number of significant advances in understanding, treating and 
preventing potential agents of bioterror have already been realized. 
For example, NIAID-supported scientists determined how anthrax toxin 
gains entry into a cell and demonstrated how the toxin can be 
effectively blocked from entering the cell, suggesting that the 
development of specific anthrax toxin-blocking compounds could be a 
viable approach to treating anthrax disease. Furthermore, intramural 
researchers at NIAID's Vaccine Research Center are working on the 
development and pre-clinical testing of an Ebola vaccine, while others 
have discovered a single gene mutation in the plague bacterium, 
Yersinia pestis, which may have been responsible for the emergence of 
the ``Black Death'' in the 14th century.
    NIAID also has expanded genomic sequencing of potential agents of 
bioterrorism, including anthrax and plague, and has recently awarded 
contracts to two companies designed to spur development of a new 
anthrax vaccine. Similarly, the Institute has new initiatives planned 
to encourage development of vaccines against plague and therapeutic 
strategies against Botulinum toxin.
    In fiscal year 2003, NIAID will establish a nationwide network of 
Regional Centers of Excellence for Biodefense and Emerging Infectious 
Disease Research and pursue an initiative to design, build, and 
renovate a system of Regional and National Biocontainment Laboratories 
to serve as national resources for biodefense research and product 
development. These facilities will include a small number of Biosafety 
Level-4 (BSL-4) laboratories, the level of containment necessary to 
study highly pathogenic organisms.
                               conclusion
    The threat of resurgent smallpox is real and its potential is 
devastating; however, the President's Plan moves us in the right 
direction to address this threat head-on. We will continue to work 
closely with the Administration, including our colleagues within HHS, 
to fully implement the President's smallpox vaccine action plan. In 
addition, NIAID will continue to bolster our biodefense research 
efforts, which span basic, clinical and product development research, 
and infrastructure development. With a strong research base and 
talented investigators throughout the country, we fully expect that 
NIAID's research programs will provide the elements essential to 
enhance significantly our nation's defenses against the threat of 
bioterrorism.
    Thank you for the opportunity to testify. I will be happy to answer 
any questions.

    Senator Specter. Thank you, Dr. Fauci.
    Before we turn to questions, I would like to turn to our 
very distinguished Ranking Member, Senator Harkin. We exchange 
the gavel from time to time and, I like to say, seamlessly. Tom 
Harkin and Arlen Specter learned a long time ago if you want to 
get something done in Washington, you have to be willing to 
cross party lines. And when you deal with health, that is a 
public matter.
    Tom.

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Thank you very much, Mr. Chairman. I 
apologize for being late. There was an accident in the tunnel 
out here and I got stuck in the tunnel.
    First of all, let me thank you for calling this hearing, 
Mr. Chairman. This is something that is of vital importance.
    I will wait for my turn for questioning.
    Senator Specter. Okay.
    Senator Murray, would you care to make an opening 
statement?

               OPENING STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Mr. Chairman, I appreciate you having this 
hearing. I will just submit my statement for the record, but I 
will just say, this is a huge concern in many communities 
across my State, as I hear from hospitals and cities who are 
now feeling the burden of having to implement the vaccines, and 
a lot of questions about why, how, who is going to pay for it, 
what the risks are, and so I really appreciate your having this 
hearing today. I think we need to have these questions answered 
for our communities.
    [The statement follows:]
               Prepared Statement of Senator Patty Murray
    Mr. Chairman, we all recognize that smallpox poses a threat. The 
questions we must answer are: How big is that threat? And is the 
administration's plan appropriate and adequately funded?
    From the Anthrax incident here in the Senate, we learned that we 
need to be prepared.
    But today as we consider smallpox, many health care providers and 
hospital administrators do not have the information they need.
    It's hard for them to evaluate the risks and benefits of 
inoculating their emergency response personnel.
    There are simply too many unanswered questions and very few 
guidelines for helping health care professionals make this important 
decision.
    This uncertainty has led S.E.I.U.--one of the major unions 
representing nurses--to advise its members to not receive the smallpox 
vaccine.
    Similarly, many hospitals--including several in Washington state--
have decided to not participate in Stage One of the Smallpox Response 
Plan.
    We are already asking so much of our emergency room doctors and 
nurses. We shouldn't ask them to accept these new risks without giving 
them a better understanding of the actual threat.
    Clearly, the administration needs to do a better job of 
communicating the threat and the potential risks.
    I also share the concern of many in my state that unfunded mandates 
on smallpox will limit their ability to respond to outbreaks of T.B. 
and other infectious diseases.
    In addition to urging the administration to provide more 
information about the risks and benefits, and to provide adequate 
funding, I would also urge the Administration to allow access to 
compensation for those workers who are injured or who suffer adverse 
health effects from the vaccine.
    Relying on Workers Compensation is not the answer because the 
threshold is set too high, and the outcome is too uncertain.
    Recently, I joined with several Senators in sending this message to 
the White House. I would urge today's witnesses from the administration 
to carry this message back.
    Injured workers and patients should be justly compensated for 
injury and harm.
    As we address the smallpox threat, let's make sure we provide the 
information, the funding, and the compensation to enable our state and 
local governments and our health care professionals to respond 
appropriately.

    Senator Specter. Thank you, Senator Murray. We will have 5-
minute rounds, which is the custom of the subcommittee.
    At the outset, my question goes to our preparedness on a 
long list of potential bioterrorist attack items. We asked the 
Center for Disease Control about this, and we got this listing 
last year: anthrax, botulism, plague, smallpox, tularemia, 
viral hemorrhagic fevers, brucellosis, Epsilon toxin, 
salmonella, escherichia coli, Glanders, melioidosis, 
psittacosis, Q fever, ricin toxin, staphylococcal enterotoxin 
B, typhus fever, viral encephalitis, water threats, and the 
list goes on and on. I will make these a part of the record so 
that the recorder will know how to spell them. Maybe somebody 
even knows how to pronounce them.
    [The information follows:]
                       Biological Diseases/Agents
                               category a
    Anthrax (Bacillus anthracis)
    Botulism (Clostridium botulinum toxin)
    Plague (Yersinia pestis)
    Smallpox (variola major)
    Tularemia (Francisella tularensis)
    Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and 
arenaviruses [e.g., Lassa, Machupo])
                               category b
    Brucellosis (Brucella species)
    Epsilon toxin of Clostridium perfringens
    Food safety threats (e.g., Salmonella species, Escherichia coli 
O157:H7, Shigella)
    Glanders (Burkholderia mallei)
    Melioidosis (Burkholderia pseudomallei)
    Psittacosis (Chlamydia psittaci)
    Q fever (Coxiella burnetii)
    Ricin toxin from Ricinus communis (castor beans) NEW!
    Staphylococcal enterotoxin B
    Typhus fever (Rickettsia prowazekii)
    Viral encephalitis (alphaviruses [e.g., Venezuelan equine 
encephalitis, eastern equine encephalitis, western equine 
encephalitis])
    Water safety threats (e.g., Vibrio cholerae,Cryptosporidium parvum)
                               category c
    Emerging infectious disease threats such as Nipah virus and 
hantavirus
                         category descriptions
Category A Diseases/Agents
    The U.S. public health system and primary healthcare providers must 
be prepared to address various biological agents, including pathogens 
that are rarely seen in the United States. High-priority agents include 
organisms that pose a risk to national security because they
  --can be easily disseminated or transmitted from person to person;
  --result in high mortality rates and have the potential for major 
        public health impact;
  --might cause public panic and social disruption; and
  --require special action for public health preparedness. /
Category B Diseases/Agents
    Second highest priority agents include those that
  --are moderately easy to disseminate;
  --result in moderate morbidity rates and low mortality rates; and
  --require specific enhancements of CDC's diagnostic capacity and 
        enhanced disease surveillance.
Category C Diseases/Agents
    Third highest priority agents include emerging pathogens that could 
be engineered for mass dissemination in the future because of
  --availability;
  --ease of production and dissemination; and
  --potential for high morbidity and mortality ratesand major health 
        impact.

    Senator Specter. Dr. Fauci, let me start with you. We are 
just talking about one of them today. How well-equipped are we 
to deal with this long litany of potential risks that somebody 
may hurl at us?
    Dr. Fauci. It is getting better prepared and better 
prepared, Mr. Chairman. That is the reason why I showed that 
slide of the research agenda. At least from the research 
standpoint, and Dr. Gerberding could comment on the other 
aspects of it, from the research standpoint, we are 
specifically targeting essentially the microbes that you 
mentioned on that list, and I will give you a few very brief 
examples.
    In anthrax, we are working on now what we call the second 
generation anthrax vaccine. The first one is a more crude 
vaccine in which you take the supernatant from the cultures of 
anthrax, and use that to inject it as a vaccine. Using 
molecular techniques, we now have what is called the 
recombinant, using recombinant DNA technology, a protective 
antigen. It is referred to as RPA, and that antigen is highly 
immunogenic in inducing an immune response, and our hope is not 
only to have a better, safer vaccine, but also one that does 
not have to have six vaccination immunizations in the program. 
Two or three is what we are aiming for.
    The other one that we feel is very important that you 
mentioned is botulism toxin. We have horse antiserum against 
it. We need to increase that supply, and we have accelerated 
our research effort to develop a monoclonal antibody against 
botulism toxin so that it can be used safely and in unlimited 
quantities.
    The final, last example, just as a prototype of what you 
are referring to, ebola, one of the hemorrhagic fevers that you 
mentioned, the third, I believe, or fourth or fifth on your 
list, we have already shown in an animal model that the vaccine 
that was developed at the NIH against ebola protects a monkey 
from intraperitoneal challenge from live ebola, and we will be 
starting phase 1 safety trials in humans in calendar year 2003, 
so we are making steady, and in some cases rather rapid and 
impressive progress on the whole array of microbes that you 
listed in your menu there.
    Senator Specter. Well, Dr. Fauci, are you saying that we 
are prepared for this entire laundry list?
    Dr. Fauci. No, we are not prepared. We are not, Mr. 
Chairman. We are not prepared right at this moment, but we have 
them--those microbes--in our crosshairs. We have targeted them 
and some of the ones you have mentioned we actually already 
have very good antibiotics against them.
    Senator Specter. Well, what I would like to have you submit 
to the subcommittee, going over this list, is which items we 
are prepared for, which items we are not prepared for, what we 
need to get prepared for all of the items. That is really what 
we have to make a determination on, and what will the cost be 
in preparing on all of these items.
    Dr. Fauci. We have actually done that, Mr. Chairman, and we 
can get an updated version of that to you relatively quickly.
    Senator Specter. And the other question is, how confident 
are we that this list is everything? Is it possible that 
somebody out there may have some other bioterrorist items that 
are not on this list?
    Dr. Fauci. That is always a possibility, not only an item 
that might not be on the list--it is unlikely there would be a 
microbe we have never heard of. That would be extremely 
unlikely, but what could happen, and there is a feasibility we 
are concerned about in trying to prepare for, is the genetic 
mutation of some of those microbes to get them to perhaps elude 
the antibiotics, where they exist, that we have for them, and/
or the body's immune response that you would expect from the 
vaccine, so that is a concern, and an important part of our 
priorities is how do we counter the genetic manipulation of 
microbes?
    Senator Specter. Before turning to Senator Harkin for his 
line of questioning, let me say--I have been advised that C-
SPAN is starting to carry our hearing live--that we are 
conducting a hearing, the fourth in a series by this 
subcommittee, on the potential of bioterrorism, and our focus 
today is on the issue of smallpox, and we have two experts with 
us at the moment, Dr. Gerberding from the Center for Disease 
Control, and Dr. Fauci from the National Institutes of Health, 
and we are going over the areas of risk of smallpox, the items 
of risk of other potential bioterrorism items for attack, what 
progress has been made, and what needs to be done for the 
future.
    At this time, let me yield to my distinguished colleague, 
Senator Harkin.
    Senator Harkin. Mr. Chairman, thank you again for your 
leadership on this committee, and for your leadership 
especially in the whole area of meeting our needs in public 
health.
    As you indicated, we have worked closely together on this. 
This is truly one of those issues that transcends any kind of 
party lines, and, again, I would just thank you for continuing 
this effort to ensure that our public health sector in this 
country is reinvigorated and rebuilt.
    I think we discovered after September 11 that our public 
health facilities in America had been neglected for far too 
long, and we as a Congress and the President have committed 
ourselves to rebuilding and reinvigorating that public health 
structure throughout the United States. We have provided the 
funds to do so, and I believe there is a commitment here to 
continue to provide whatever funds are necessary to upgrade and 
ensure that our public health facilities around America are 
first-class, and are ready to meet present needs, but any 
emerging needs that we might have in the public health sector.
    I want to thank you, Dr. Gerberding, for your leadership in 
this area as the head of the Center for Disease Control and 
Prevention, and you, Dr. Fauci, for your many years of service 
to this country at NIH.
    There is a lot of concern, I think, amongst us here, and in 
my State, that the funds that we have provided for upgrading 
our public health facilities are now going to be needed or 
siphoned off to meet this proposal to vaccinate against 
smallpox on this broad basis that we are talking about. I think 
the decision has been made to move in that way, but where is 
the money coming from that will provide the support for the 
vaccinations?
    I find a lot of concern that our State Public Health 
Directors are saying:

    ``Wait, you have just given us the money to start upgrading 
our facilities. We are doing that now. Now we have to slow that 
down, or stop that, and siphon money off of that for smallpox 
vaccination.''

    I guess I would ask you, Dr. Gerberding, to comment on 
that. How much money are we talking about total that we are 
going to need for the phase 1 for all the first responders, and 
if we do decide to go into phase 2--I do not think that has 
been decided yet, has it? Phase 1 and 2 have been decided. How 
much are we talking about, in terms of total amounts of money, 
is that going to cost? Do we have any idea? Can you tell us?
    Dr. Gerberding. This is a very difficult question. I 
appreciate your asking it. We did put out the $1.1 billion this 
year for general public health preparedness for terrorism and 
other threats, and when we put that money out, we were not 
prepared to implement the vaccination program with those 
dollars, and so we have to look at what investments have we 
made that can contribute to this program, and are there gaps in 
what we have put out, and what is really needed to bring this 
program forward?
    We are providing the vaccine free. We have invested in 
infrastructure and things like how to deliver the 
pharmaceutical stockpile, how to train clinicians to be 
prepared, and so forth, and we have looked at some of the 
estimates that our colleagues in the States have provided us. 
At CDC, we did an economic assessment which looks at the 
indirect and direct costs of the program to get some handle on 
this, but it is very, very difficult to know, mainly because we 
have never done this before.
    If we look just at what it costs to actually deliver the 
vaccine to people, to get it into people's arms when they come 
to a clinic, we think that the cost-per-injection is somewhere 
between $10 to $15, and for planning purposes, we are using the 
figure of $13, but that estimate is made on the assumption that 
the money we just put out, plus the $918 million we expect we 
will probably be able to put out in August with the next 
installment of the appropriation from this committee, that we 
will be able to use that infrastructure to support this 
program, and we will have to monitor this and look at it as we 
go forward to identify any gaps.
    Senator Harkin. That figure you just gave me is a little 
bit better than what I have heard in the past, I must admit. I 
mentioned in a statement on the floor of the Senate here within 
the last couple of weeks in talking about this, I was looking 
at the cost, and it hit me that some of the figures I had been 
seeing of several hundred dollars a person just seemed to me to 
be way out of line with what it might cost to vaccinate someone 
for smallpox.
    I hope we get a better handle on this, on just what we are 
talking about in terms of cost, and what we might have to help 
reimburse the States, or get money out to the States to help 
them afford this, but whatever it is, I do not want the--I 
think this is something we are going to have to deal with 
separately and apart from the funding that we have already put 
out for the upgrading of facilities and to meet the bioterror, 
other threats we have out there that Senator Specter just 
talked about, and that you have talked about, Dr. Fauci. It has 
to be a separate type of thing targeted just for smallpox.
    Dr. Fauci, this is a question I have about an article that 
appeared in The Washington Post about protecting against 
smallpox, and it says here, ``who should not be vaccinated,'' 
and obviously, people with weakened immune systems, breast-
feeding mothers, younger than 18 years of age.
    Dr. Fauci. Right.
    Senator Harkin. Is that right? I mean, children should not 
be vaccinated?
    Dr. Fauci. Right now, if you look at the program as it is 
constituted, health care workers, military, others, children 
are not included in that. In the case of an emergency, were we 
to get hit by a smallpox massive attack and we instituted a 
combination of the ring vaccination with the contacts as well 
as an extensive, Nation-wide vaccination, we certainly would 
vaccinate children less than 18 years old.
    We are talking about the situation right now with the 
vaccine as it is being used.
    Senator Harkin. Oh, I see. It is not that they are at any 
special risk, because obviously, when I got vaccinated against 
smallpox I was in grade school.
    Dr. Fauci. We all were vaccinated as children, but 
currently the vaccine we are using right now, for the purposes 
we are using it right now, is not going to be involving 
children.
    Senator Harkin. It is not a medical situation, then, in 
other words?
    Dr. Fauci. Well, certainly if you get to infants less than 
1 year old, the problem with infants zero to 1 is higher than 
that in individuals who are older, but the difference between a 
17- or 18-year-old and a 21-year-old is essentially 
nonmeasurable.
    Senator Harkin. I understand. Okay. I did not understand. I 
think I understand. Thank you very much, Doctor.
    Senator Specter. Thank you, Senator Harkin.
    Senator Murray.
    Senator Murray. Well, thank you, Mr. Chairman. I think 
everyone here, particularly in this Capitol Building, is 
certainly aware of bioterrorist attacks after the anthrax 
situation that occurred a year ago, and we understand that 
prevention is important, and we understand the impacts of any 
kind of bioterrorist attack.
    As I go out into my communities across Washington State, 
many people are expressing real deep concern to me about the 
risks of vaccinating a population in whole today, and I know 
that we are just looking at our first responders at this point 
and health care people who may be exposed early on, but there 
is a huge question in the minds of many of what kinds of risks 
we are taking, and what the real risk of a smallpox infection 
could be.
    We all understand it is a horrible disease. We do not want 
to see any kind of attack occur that would harm our 
populations, but the question I get all the time is two-fold: 
What is the risk of this happening? And second: How are we 
going to pay for its implementation? There is serious concern 
in all of my communities--small, rural, suburban, urban--how 
they are ever going to be able to pay for this without funding 
from us, so let me start with the risk.
    I think we all really want to know what are the real risks 
of a smallpox attack? Is this something that could potentially 
end up in the hands of terrorists? Can it be weaponized? Are 
there more sources than we know? I know there are two known 
sources, one in Atlanta, and one in Moscow. Are there more than 
that?
    Can either one of you give me a solid answer of what is the 
real risk of a smallpox attack in this country?
    Dr. Gerberding. I can try to address part of your question. 
We cannot give you an absolute quantitation of the risk, but I 
do not think anyone can tell you what is the quantitative 
probability of a smallpox attack, and I cannot discuss all of 
the details because some of the information is, of course, 
classified, but I think our reading of the intelligence that we 
share with the intelligence community is that there is a real 
possibility of a smallpox attack from either nations that are 
likely to be harboring the virus, or from individual entities 
such as terrorist cells that could have access to the virus.
    So we know it is not zero, and I think that is really what 
we can say with absolute certainty, that there is not a zero 
risk of a smallpox attack and, as Dr. Fauci pointed out, the 
disease is so terrible, and anyone in our country under the age 
of 30 basically has absolutely no immunity to this at all, that 
should an attack occur, it would be absolutely devastating 
situation for us, and we have to get our response capacity 
organized so that should that unthinkable thing happen, we 
would be able to take the steps we need to very quickly protect 
our entire country.
    We are not recommending immunizing the entire country right 
now, because there are hazards from the vaccine, and the 
balance right now in the President's perspective, and he did a 
very thorough job of assessing all of the risks and benefits 
and complications of this policy, the conclusion was at this 
point in time the risk is not sufficient to justify exposing 
the entire population to the side effects, but we did need to 
step up to the plate and get our emergency response capacity 
ready to go should we need it.
    Dr. Fauci. Senator Murray, one other issue, just to answer 
another part of your question, I agree, we cannot quantify in 
any accurate way whatever what the risk is, we just cannot, but 
you asked a question about, can it be weaponized. At the time 
that the smallpox epidemic, pandemic was declared eradicated, 
and the WHO asked all of the nations who have supplies of 
smallpox to either turn it in or destroy it, and there were 
two, as you mentioned accurately, one in the Soviet Union and 
one in Atlanta.
    The fact is, in the 1970s and 1980s, we know, absolutely 
documented, that the Soviet Union was mounting a massive 
biowarfare campaign and making dozens of tons of weaponized 
smallpox, so the answer to your question of, Can it be 
weaponized, the answer is, Yes, it can. Yes, it can. Yes, it 
has been in the past.
    Supposedly, those stores have been destroyed, but one of 
the concerns, again with no definitive evidence, is that if you 
have dozens and dozens of tons of documented, made smallpox 
biowarfare at the time of the dissolution of the Soviet Union, 
when many of those scientists and technicians were in some 
economic difficulties, the question always arises, could there 
have been a possibility that some of that material got out of 
the hands of the guards within the Soviet Union and happened to 
get into the hands of people who would use it in nefarious way?
    I do not have any definitive intelligence that says that 
happened, but that is not an unreasonable possibility, since it 
is so easy to grow, and relatively easy to put in a form where 
you could make large quantities.
    Senator Murray. Okay. So you can definitively say there are 
risks in not moving forward in some kind of vaccination?
    Dr. Fauci. Yes.
    Senator Murray. But you can also definitively say that 
there are risks in vaccinating our population at the present 
time, and even on your own web site, you say who should not be 
vaccinated. I think Senator Harkin said those under 18, 
pregnant women, nursing women. The risks associated with 
vaccination are clear as well.
    Some of the concerns I am hearing are it is not just the 
person who is vaccinated, but if they go home, they could 
infect someone they live with. Is that a real possibility?
    Dr. Fauci. Yes. That is called contact vaccinia, where 
someone gets vaccinated. That is almost exclusively, though not 
exclusively, but almost always happens in a situation where 
someone would go home in household contact of a child who is 
vaccinated, who passes it on to a sibling in the house, or 
someone who is vaccinated, and might pass it on to someone with 
whom they have close contact, like----
    Senator Murray. A spouse to a pregnant woman.
    Dr. Fauci. Yes. That is an unusual situation, but it is not 
impossible. We have to realize that there is a risk, though it 
usually is when you vaccinate children, not exclusively. That 
is something that we do recognize when we engage in these 
programs.
    Senator Murray. Knowing what that risk, then is, what are 
we doing to educate those who are now responsible in thousands 
of communities across the country who are being told now to 
vaccinate? How do we educate them, educate the people who are 
receiving vaccinations to make sure that we eliminate or as 
closely as possible reduce the risks associated with 
vaccination?
    Dr. Gerberding. We are taking many steps to educate a 
variety of target populations, but let us just start with the 
vaccine volunteers, the people who are considering whether they 
are able or willing to participate in this program. We have 
several different methods. We are using satellite broadcasts, 
we are using written materials, we are using webcasts, we are 
also training the clinicians. We are encouraging them to engage 
in conversations about their own personal risk and their 
hazard. We are preparing to distribute 3\1/2\ million copies of 
the important elements of this program to clinicians around the 
United States so that all of the nurses and doctors who might 
be asked questions or provide consultation will have that 
information.
    We are also working with the public health system and all 
of the people putting together these clinics so that they can 
train others. We have put this kind of information in the hands 
of over 800,000 people so far, and we are working on expanding 
that even further as we speak.
    Today, for example, we are initiating a program to help 
clinicians working in the vaccine clinics be able to run the 
clinic and recognize the adverse events of the smallpox 
vaccine.
    Senator Murray. Mr. Chairman, I know my time is up. I would 
just say it is a long ways from Washington, DC to counties out 
in my State and rural communities, and a lot of steps along the 
way, and it is incredibly important that we spend the time to 
make sure people get the information so they can make good 
decisions about themselves. That has to be a part of that. I 
was not able to ask about cost, but that is an associated cost 
as well that we need to understand.
    Thank you, Mr. Chairman.
    Senator Specter. Thank you, Senator Murray.
    Senator Landrieu.

             OPENING STATEMENT OF SENATOR MARY L. LANDRIEU

    Senator Landrieu. Thank you, Mr. Chairman. I do have a 
statement to submit for the record. I will just make three very 
brief points, and I am, of course, interested in hearing from 
the panel.
    First of all, although it is not the actual subject of our 
subcommittee, I do think that this whole issue should focus the 
Congress more directly on the nonproliferation issues. We have 
focused for many years on nonproliferation of nuclear weapons, 
but there have been calls in this committee. The subject of 
this committee should remind us and reenergize us into the 
issue of nonproliferation of biological and chemical weapons. 
It is one thing to deal with the consequences of an attack. It 
is another thing to spend some money on the front end in energy 
preventing the attack by identifying these materials and really 
investing on the front end, which is not the subject of this 
subcommittee, but is the subject of the Appropriations 
Committee generally, and how our resources as a Nation are 
being used.
    Second, I would hope, Mr. Chairman, that our committee 
would be committed to picking up as close to 100 percent of 
this cost as possible for the States who are strapped 
budgetwise. This is part of our sort of defense as a Nation. I 
hope that we do not go into this looking at a 30-70 match, or a 
50-50 match. Just like we pick up about 100 percent of the cost 
of our military, I think the Federal Government has a real 
obligation to try to minimize the cost and then pick it up as 
much as possible.
    Third, what comes to mind on this subject is the fairness 
of our distribution system. It reminds me of the Titanic. When 
the boat or the ship hit the iceberg, you know, I remember the 
movie so clearly about all the wealthy people got the lifeboats 
and the poor people were locked in the lower part of the boat, 
and ever since I saw that movie, even as a young child, it was 
quite disturbing, and that view still stays in my mind.
    So this distribution system, should an attack occur and we 
cannot rely on the fairness and equity of the health care 
system--there are some communities that have lots of nurses, 
lots of doctors, lots of hospitals, and lots of clinics, and 
then there are plenty of places, many of them in Louisiana, who 
have not seen a doctor in a long time and have to actually 
recruit nurses to their communities. So this is a huge, huge 
undertaking for us to try to make sure that everyone is treated 
not according to the size of their pocketbook in the event of 
an attack, or their social status in their community, and it is 
a tremendous obligation we have, so I hope we will really think 
very carefully about that particular issue as we lay out and 
appropriate the funds.

                           prepared statement

    The final point I want to make is with the turnover of our 
personnel, because the pay is usually low, people come in and 
out of our health care system all the time. I hope we are 
setting up a national certification, so whether you were 
trained as a nurse, but then went into another business, if an 
attack hits, there is a database available of people who have 
been trained and they can be called from other professions to 
the front lines, because that is what it is going to take, and 
that is going to take a whole rethinking of how we do training 
and certification, and it becomes sort of lifelong 
certification in the event, because we are in this for the long 
run.
    Mr. Chairman, those are some of my thoughts.
    [The statement follows:]
             Prepared Statement of Senator Mary L. Landrieu
    Mr. Chairman, given that just four days have passed since the 
thirty-seventh Superbowl, an event that has become as much a part of 
America as apple pie, I thought it would be appropriate to begin my 
remarks this morning with a tried and true adage from the world of 
sports, ``the best defense is a good offense.'' This certainly proved 
true for this weekend for the Tampa Bay Bucks and I think that it 
applies equally well to the subject at hand. Yesterday, in his State of 
the Union Speech, President Bush warned, ``we must assume that our 
enemies would use these diseases as weapons and we must act before the 
dangers are upon us.'' The evidence suggests that he is right. I, for 
one, intend to do all that I can to ensure that America stands ready 
and that our people are protected.
    As this committee knows, through the efforts of the Department of 
Health and Human Services and our state and local officials, America 
has stockpiled enough vaccine to inoculate our entire population in the 
event of a smallpox attack. Let that be a message to those who wish to 
harm us that we are ready to respond quickly and effectively to this 
emergency. The next step, of course, is to ensure that our plan for 
delivery of this vaccine is both safe and effective. As a member of the 
Armed Services Committee, I was briefed extensively about the dangers 
of mass hysteria in an event of this nature. Through careful planning 
and federal, state and local cooperation, we can safeguard the health 
and safety of all Americans.
    I would like to personally thank and commend all of those 
volunteers who have come forward to form the Smallpox Response Teams. 
Once again, it is the men and women of our law enforcement, our 
doctors, nurses and other first responders who will help form the first 
line of defense in this war against terror. Because of you and the men 
and women of our Armed Forces, Americans can sleep easier tonight 
knowing that there are people who stand ready to protect them and the 
freedoms they love.
    That being said, I have two concerns that I think need to be 
discussed further this morning. First, I think it is imperative that 
the CDC evaluate more fully investigate the rate of serious reactions, 
the effectiveness of current warnings on the risks of being vaccinated, 
and consider creating a smallpox vaccination compensation fund, which 
exists for other vaccines but not for smallpox. Without a reasonable 
way to reimburse people for their expenses and protect them from undue 
harm as a result of the vaccination, people may decline to be 
vaccinated, thus undermining the effectiveness of the program.
    Second, I am concerned about whether enough thought has been given 
to the additional cost these vaccination efforts will place on our 
already struggling state, local and hospital budgets. Under the 
President's plan, 10.5 million people are scheduled to be vaccinated in 
the next few months. This is yet another example of the President's 
apparent budget policy, ``I say, they pay.'' Protecting the nation from 
a small pox attack and effectively managing a small pox crisis should, 
God forbid, one occur, is the responsibility of the federal government. 
Therefore, I think that we should be prepared to pick up 100 percent of 
this cost and not shift this burden to the States.
    Finally, I think a lot more thinking has to go into how this plan 
will be implemented in the event of an attack. Knowing what I do about 
the vaccination process, it appears to me that it is an enormous task 
we are undertaking. I think that we must think about the many different 
communities that could be affected. Most importantly, I hope that we 
ensure that all Americans, regardless of the socio-economic status, 
age, or education, will have access to being vaccinated. This calls to 
mind the example of the Titanic, when they reached a crisis point, it 
was the wealthy who got the life-boats, the poor were left to die. I 
hope we will not repeat that mistake in the event of a bio-terrorist 
attack.
    Again, thank you Mr. Chairman for calling this important hearing. I 
look forward to hearing from the panels.

    Senator Specter. Thank you very much, Senator Landrieu.
    We are going to move ahead to the second panel, but we 
would like for both Dr. Gerberding----
    Senator Harkin. Can I ask one follow-up question, please?
    Senator Specter [continuing]. And Dr. Fauci to stay.
    Senator Harkin, I am suggesting coming back to the 
witnesses. We have another panel with five witnesses, and my 
preference would be to call the next panel and then to ask Dr. 
Gerberding and Dr. Fauci to stay.
    Dr. Gerberding, for example, has a vaccine kit which she 
wants to demonstrate, and we will come back to you, but I would 
like, as a matter of sequence, to proceed with the other 
witnesses.
    Dr. Gerberding. Thank you.
    Senator Specter. We will call the second panel now: Dr. 
Brian Strom, Dr. Louis Bell, Mr. Patrick Libbey, Mr. James 
August, Ms. Jane Colacecchi.
STATEMENT OF BRIAN STROM, M.D., M.P.H. CHAIR, INSTITUTE 
            OF MEDICINE COMMITTEE ON SMALLPOX 
            VACCINATION, DIRECTOR, CENTER FOR CLINICAL 
            EPIDEMIOLOGY AND BIOSTATISTICS, UNIVERSITY 
            OF PENNSYLVANIA
    Senator Specter. Our first witness here, Dr. Brian Strom, 
is Chair of the Institute of Medicine Committee on Smallpox 
Vaccination, which earlier this month released a report 
advising CDC on its implementation of the vaccination program. 
Dr. Strom is also professor and Chair of the Department of 
Biostatistics and Epidemiology at the University of 
Pennsylvania, received his M.D. from Johns Hopkins and his 
master's of public health from the University of California at 
Berkeley.
    Dr. Strom, welcome, and we look forward to your testimony.
    Dr. Strom. Thank you, Mr. Chairman. Good morning, Mr. 
Chairman and members of the subcommittee. Thank you for the 
opportunity to come to speak with you this morning. As 
mentioned, my name is Brian Strom. I am professor and chair of 
the Department of Biostatistics and Epidemiology and professor 
of medicine at the University of Pennsylvania School of 
Medicine. I am also chair of the Institute of Medicine 
Committee on Smallpox Vaccine Program Implementation.
    The Institute of Medicine and the National Academies is an 
independent, nongovernmental, nonprofit organization operating 
under the 1863 congressional charter to the National Academy of 
Sciences. The Institute of Medicine has provided advice to the 
Nation on matters of health and medicine for over 30 years. The 
Centers for Disease Control and Prevention formally engaged the 
services of the Institute of Medicine in September 2002, and 
the Committee on Smallpox Vaccination Program Implementation 
met for the first time in December 2002.
    The committee's areas of expertise include internal 
medicine, infectious diseases, including smallpox disease and 
smallpox vaccination, dermatology, pediatrics, nursing, 
epidemiology, public health law and ethics, public health 
practice, emergency medicine, and pharmacology. CDC charged the 
IOM committee with providing advice to CDC and its public 
health partners on how to best implement the President's policy 
on pre-event smallpox vaccination, addressing eight areas.
    The IOM agreed to provide advice on these areas through a 
series of timely reports. During its first meeting in late 
December 2002, the committee heard from CDC, the Department of 
Defense, Israel's Ministry of Health, and representatives of 
health professional organizations. The information provided 
during these presentations and subsequent research were the 
basis for the committee's deliberations. Based on these 
deliberations, the committee released its first letter report 
on January 17, 2003, entitled: ``Review of the Centers for 
Disease Control and Prevention's Smallpox Vaccination Program 
Implementation.''
    The committee would first like to convey its appreciation 
for the hard work of CDC and its State and local partners in 
planning the pre-event smallpox vaccination program and helping 
it to become operational so quickly. CDC has done a tremendous 
job under very tight time lines. The committee also recognizes 
that this is a program that is planned nationally but 
implemented locally. CDC is offering guidance, training, and 
assistance to its State and local public health partners, but 
the local programs will be making their own decisions about how 
and when to operationalize the pre-event smallpox vaccination 
programs in their communities.
    Our report contains 23 recommendations which are summarized 
in appendix A of the report, and it has been submitted for the 
record. For the sake of time, I will not discuss all 23 
recommendations during my testimony, but would direct you to 
the full report for a complete description. I will now focus on 
the committee's four key messages, and draw attention to a few 
of its recommendations.
    The first key message was to highlight the unique nature of 
the smallpox vaccination program as a public health component 
of a national bioterrorism preparedness policy focusing on the 
delivery of clear, consistent, science-based information. The 
committee believes that it is critically important to stress to 
potential vaccinees and to the public that the pre-event 
smallpox vaccination program is not a typical public health 
program.
    Public health vaccination programs are typically undertaken 
knowing the risks of a disease and knowing they outweigh the 
risk associated with the vaccination. With the pre-event 
smallpox vaccination program, the risk of the disease is based 
on a risk estimate derived by the President and his advisors 
based on national security issues. In this context, the 
individuals being asked to take this vaccine are being asked to 
volunteer to join smallpox response teams for the benefit of 
the Nation's bioterrorism preparedness.
    The committee believes that the unique aspects of the pre-
event smallpox vaccination program need to be communicated 
clearly and consistently to the American public. Because the 
smallpox vaccination program is unusual, it is important for 
the American public to understand that practices in these 
circumstances might differ from those of traditional 
vaccination programs. A clear understanding of the risks and 
unique aspects of the pre-event smallpox vaccination program 
will be necessary to ensure that all potential vaccinees can 
make an informed decision about whether or not to participate.
    Our second key message was to proceed cautiously, allowing 
continuous opportunity for adequate and thoughtful 
deliberation, analysis, and evaluation; embark on phase 2 only 
after adequate evaluation of phase 1 has occurred. The current 
program is designed with the best possible efforts in the 
limited time frame available, but on the basis of data that are 
decades old. Our scientific approaches have improved since 
then, and our society has also changed since then. This means 
that, as modern experience is gained, rapid and real-time mid-
course corrections may be necessary.
    I would like to stress that, by recommending that CDC 
proceed cautiously, the committee never implied that CDC was 
proceeding too quickly, or without due caution, as has been 
somewhat misstated in some of the press reports on the 
committee recommendations. The committee did not recommend that 
the vaccination program be delayed or slowed down. The 
committee only encouraged CDC to facilitate local 
implementation at the pace that safety would allow. CDC has 
acknowledged that these are its intentions, and the committee 
believes that CDC will proceed accordingly.
    I would also like to stress that we have not recommended 
any specific time interval that is appropriate between the two 
phases. This is a matter of data analysis, not strictly a 
matter of time. Recognizing that the CDC has indicated that 
data analysis will be ongoing throughout phase 1, the time 
needed to analyze phase 1 data and evaluate the adequacy of 
different components of the program before embarking on phase 2 
may range from hours, to weeks, to months. The committee 
believes that CDC will be able to determine when enough data 
analysis has occurred to commence phase 2 safely.
    Our third key message was to use a wide range of methods 
for proactive communication, training, and education, and to 
customize it to reach diverse audiences, including potential 
vaccinees, all health----
    Senator Specter. Dr. Strom, could you sum up at this point? 
You are over time at this juncture.
    Dr. Strom. Sure. I will skip through, sure--all health care 
providers and the general public. Our last message was to 
designate one credible, trusted scientist as a key national 
spokesperson for the campaign and to sharpen and expand 
communication plans. The spokesperson could be Dr. Gerberding 
herself, certainly an articulate and credible scientist, or 
someone else.
    Last, I just wanted to make a statement about compensation. 
Since current discussions about the pre-event campaign are 
focusing on the issue of compensation for medical expenses or 
lost income for any health care workers who experience adverse 
reactions, I wanted to highlight the committee's 
recommendations there.
    First, we felt that the informed consent forms need very 
explicit notification of the availability, or lack thereof, of 
compensation for adverse reactions.
    Second, we thought that some adverse reactions would be 
covered by State Worker's Compensation, but others might not. 
There needs to be clarification about that.
    Last, we were concerned that the lack of compensation for 
adverse reactions might imperil the ability of the pre-event 
campaign to achieve its goal of preparedness. There are 
currently no data to determine that, but we recommended that if 
it is determined that a lack of compensation is jeopardizing 
overall progress, then the CDC, HHS, and Congress should 
support all efforts to bring the issue of compensation for 
adverse reactions to speedy resolution.

                           prepared statement

    Thank you for the opportunity to speak to you today. The 
committee hopes that its advice is useful to CDC and the 
broader community. I would be happy to answer any questions you 
may have.
    [The statement follows:]
                Prepared Statement of Dr. Brian L. Strom
    Good morning, Mr. Chairman and members of the Subcommittee. Thank 
you for the opportunity to come speak to you this morning. My name is 
Brian Strom. I am Professor and Chair of the Department of 
Biostatistics and Epidemiology and Professor of Medicine at the 
University of Pennsylvania School of Medicine and Chair of the 
Institute of Medicine (IOM) Committee on Smallpox Vaccination Program 
Implementation. The Institute of Medicine of the National Academies is 
an independent, non-governmental, non-profit organization operating 
under the 1863 congressional charter to the National Academy of 
Sciences. The Institute of Medicine has provided advice to the nation 
on matters of health and medicine for over 30 years.
    The Centers for Disease Control and Prevention (CDC) formally 
engaged the services of the Institute of Medicine in September 2002, 
and the Committee on Smallpox Vaccination Program Implementation met 
for the first time in December 2002. The committee's areas of expertise 
include internal medicine, infectious diseases (including smallpox 
disease and smallpox vaccination), dermatology, pediatrics, nursing, 
epidemiology, public health law and ethics, public health practice, 
emergency medicine, and pharmacology.
    CDC charged the IOM committee with providing advice to CDC and its 
public health partners on how to best implement the President's policy 
on pre-event smallpox vaccination, addressing the following eight 
areas:
    1. the informed consent process;
    2. contraindications screening;
    3. the system in place to assess the safety profile of the smallpox 
vaccine;
    4. guidance for the treatment of vaccine complications;
    5. professional training programs CDC is developing;
    6. the communications efforts;
    7. guidance CDC offers to states in developing their implementation 
plans; and
    8. overall progress at achieving the goals of the program.
    The Institute of Medicine agreed to provide advice on these areas 
through a series of timely reports.
    During its first meeting December 18-20, 2002, the committee heard 
from CDC, the Department of Defense, Israel's Ministry of Health, and 
representatives of health professional organizations. The information 
provided during these presentations and subsequent research were the 
basis for the committee's deliberations. Based on these deliberations, 
the committee released its first letter report on January 17, 2003, 
titled ``Review of the Centers for Disease Control and Prevention's 
Smallpox Vaccination Program Implementation.''
    The committee would first like to convey its appreciation for the 
hard work of CDC and its state and local partners in planning the pre-
event smallpox vaccination program and helping it to become operational 
so quickly. CDC has done a tremendous job under very tight timelines.
    Before getting into some of the committee's recommendations and key 
messages, I would like to point out that the committee realizes that 
while it had been working on the report, CDC had been moving ahead with 
plans for the vaccination program. Thus, the committee recognizes that 
CDC may have already accomplished some of the recommendations laid out 
in our report.
    The committee also recognizes that this is a program that is 
planned nationally, but implemented locally. CDC is offering guidance, 
training, and assistance to its state and local public health partners, 
but the local programs will be making their own decisions about how and 
when to operationalize the pre-event smallpox vaccination program in 
their communities.
    The report contains 23 recommendations, which are summarized in 
Appendix A of the report. For the sake of time, I will not discuss all 
23 recommendations during my testimony, but would direct you to the 
full report for a complete description of the recommendations, which I 
am submitting for the record. I will now focus on the committee's four 
key messages and draw attention to a few of the recommendations.
    Our first key message was: Highlight the unique nature of the 
smallpox vaccination program as a public health component of a national 
bioterrorism preparedness policy, focusing on the delivery of clear, 
consistent, science-based information.
    The committee believes that it is critically important to stress to 
potential vaccinees and the public that the pre-event smallpox 
vaccination program is not a typical public health program. Public 
health vaccination programs are typically undertaken knowing the risks 
of the disease, and knowing they outweigh the risks associated with the 
vaccination. With the pre-event smallpox vaccination program, the risk 
of the disease is based on a risk estimate derived by the President and 
his advisors, based on national security issues. In this context, the 
individuals being asked to take this vaccine are being asked to 
volunteer to join smallpox response teams, for the benefit of the 
nation's bioterrorism preparedness. The committee believes that the 
unique aspects of the pre-event smallpox vaccination program need to be 
communicated clearly and consistently to the American public. Because 
the smallpox vaccination program is unusual, it is important for the 
American public to understand that practices in these circumstances 
might differ from those in traditional vaccination programs. A clear 
understanding of the risks and unique aspects of the pre-event smallpox 
vaccination program will be necessary to ensure that all potential 
vaccinees can make an informed decision about whether to participate.
    Our second key message was: Proceed cautiously, allowing continuous 
opportunity for adequate and thoughtful deliberation, analysis, and 
evaluation. Embark on phase II only after adequate evaluation of phase 
I has occurred.
    The current program is designed with the best possible efforts in 
the limited time frame available, but on the basis of data that are 
decades old. Our scientific approaches have improved since then, and 
our society has also changed during this time. This means that, as 
modern experience is gained, rapid and real-time midcourse corrections 
might be necessary.
    I would like to stress that by recommending that CDC ``proceed 
cautiously,'' the committee never implied that CDC was proceeding too 
quickly or without due caution, as has been somewhat misstated in some 
of the press reports on the committee's recommendations. The committee 
did not recommend that the vaccination program be delayed or slowed 
down. The committee only encouraged CDC to facilitate local 
implementation at the pace that safety would allow. CDC has 
acknowledged that these are its intentions, and the committee believes 
that CDC will proceed accordingly.
    I would also like to stress that we have not recommended any 
specific time interval that is appropriate between the two phases. This 
is a matter of data analysis, not strictly a matter of time. 
Recognizing that the CDC has indicated that data analysis will be 
ongoing throughout phase I, the time needed to analyze phase I data and 
evaluate the adequacy of different components of the program before 
embarking on phase II (such as screening guidelines and surveillance 
for adverse reactions), may range from hours to weeks to months. The 
committee believes that CDC will be able to determine when enough data 
analysis has occurred to commence phase II safely.
    One way to evaluate the adequacy of different components of the 
program would be to take advantage of differences in the way that 
public health departments and hospitals administer their local smallpox 
vaccination programs. Because local vaccination programs will be making 
their own decisions about the types of bandages to use, specific site 
care instructions, adverse reaction investigation, degree of patient 
contact allowed, and whether to grant administrative leave to 
vaccinated health care workers, the committee urged CDC to utilize and 
analyze these data before embarking on phase II.
    Our third key message was: Use a wide range of methods for 
proactive communication, training, and education, and customize it to 
reach diverse audiences, including potential vaccinees, all health care 
providers, and the general public.
    The committee heard evidence that there is much confusion about 
smallpox disease, the vaccine, and the details of the vaccination 
program. The committee strongly believes that clear, consistent 
communications to many different types of audiences is intrinsic to the 
success of the pre-event smallpox vaccination program. Given the 
potential for misinformation and confusion, and the complexity of 
vaccine information, it is necessary to begin a campaign of informing 
and educating the general public as soon as possible. Waiting until 
reports of serious adverse reactions surface is too little too late. 
Communicating in a time of crisis can only be effective if adequate 
communication and education have occurred during preparedness planning.
    Our last key message was: Designate one credible, trusted scientist 
as key national spokesperson for the campaign and sharpen and expand 
communication plans and strategies to ensure rapid, transparent, and 
sustained contact with the media throughout implementation.
    For the public to maintain confidence in the pre-event smallpox 
vaccination program and CDC, the committee believes that it is 
important for CDC to speak from its strength--the science of public 
health. Discussion of national security matters is best left to 
national security experts. The public's confidence in the vaccination 
program will be strengthened by the availability of a key scientific 
spokesperson who can provide credible and consistent information in a 
manner that is easily understandable to many different audiences. The 
spokesperson could be Dr. Gerberding herself, certainly an articulate 
and credible scientist, or someone else.
    Since current discussions of the pre-event smallpox vaccination 
program are focusing on the issue of compensation for medical expenses 
or lost income for any health workers who experience adverse reactions 
from the smallpox vaccine, I will highlight the committee's 
recommendations that relate to this issue.
    Although not specifically identified as an item for our 
deliberation, the committee did believe strongly that we needed to 
address the issue of compensation since it could have implications to 
the issues of informed consent and progress at achieving the overall 
goal of the program (that being increasing the nation's bioterrorism 
preparedness), both of which are clearly within our mandate.
    The committee recommended that informed consent forms include 
explicit notification of the availability--or lack thereof--of 
compensation for adverse reactions. The committee was concerned that 
many potential vaccinees may falsely assume that the provisions of the 
Homeland Security Act of 2002 or the federal Vaccine Injury 
Compensation Program would provide compensation for medical expenses or 
income loss experienced as a result of receiving or being exposed to 
the smallpox vaccine (when there are no instances of negligence). This 
information may be an important factor that could weigh on a potential 
vaccinee's decision about whether to receive the vaccine.
    The committee also recognized that some adverse reactions 
experienced by vaccinees may be covered by state worker's compensation 
programs. However, there is much uncertainty and confusion surrounding 
the types of vaccine adverse reactions and circumstances leading to 
those adverse reactions that would be coverable under each state's 
worker's compensation law. Because of this, the committee recommended 
that CDC and its state and local public health partners work to clarify 
the scope of worker's compensation for adverse reactions to the 
smallpox vaccine.
    The committee was also concerned that the lack of compensation for 
adverse reactions might--I stress, ``might''--imperil the ability of 
the pre-event vaccination program to achieve its goal of preparedness 
to respond to a smallpox attack. There currently are no data to 
determine whether or not the lack of compensation for adverse reactions 
is indeed a deterrent to receiving the vaccine. However, the committee 
recommends that IF it is determined that lack of compensation is 
jeopardizing overall progress at achieving the goals of the program 
(which is an item in our charge), then CDC and the Department of Health 
and Human Services should support all efforts to bring the issue of 
compensation for adverse reactions--including those reactions that 
occur despite non-negligent manufacture and administration of the 
vaccine--to speedy resolution.
    The committee offered many additional recommendations related to 
the implementation of the pre-event smallpox vaccination program. I 
would be happy to answer questions about any additional recommendations 
of interest to you.
    Thank you for the opportunity to speak to you today. The IOM 
Committee on Smallpox Vaccination Program Implementation hopes that its 
advice is useful to CDC and the broader community concerned about the 
success of the pre-event smallpox vaccination program. I would be happy 
to answer any questions you may have.
STATEMENT OF LOUIS M. BELL, M.D., CHAIR, DIVISION OF 
            INFECTIOUS DISEASE, CHILDREN'S HOSPITAL OF 
            PHILADELPHIA
    Senator Specter. Thank you, Dr. Strom. We now turn to Dr. 
Louis M. Bell, chief of the Division of General Pediatrics at 
Children's Hospital of Philadelphia, also serves as Medical 
Director for the Hospital Infection Control Department at 
Children's Hospital, received his M.D. from the University of 
Maryland, and did his residency at Hahnemann in Philadelphia. 
Thank you for joining us, Dr. Bell, and the floor is yours.
    Dr. Bell. Thank you. It is a pleasure to have this 
opportunity to speak to the committee on this complex topic of 
smallpox vaccination and its particular impact on the pediatric 
hospital population. I am here today representing the 
physicians, nurses, and other health care providers and 
administrators at the Children's Hospital of Philadelphia, and 
I will attempt to summarize a number of issues that we, as a 
hospital, have been considering in response to President Bush's 
December 13 call to develop a voluntary pre-event smallpox 
vaccination program.
    The Children's Hospital of Philadelphia is regarded as a 
world leader in pediatrics. We operate the largest pediatric 
health care system in the United States, handling more than 
770,000 outpatient visits each year. On our main campus in 
Philadelphia, we admit more than 20,000 children annually and 
have approximately 65,000 emergency department visits each 
year.
    Now, I recite these statistics not to impress the 
committee, but rather, to help you understand two points, first 
that we are fortunate to have some of the brightest people in 
pediatric medicine deliberating on this issue and, second, we 
must carefully consider the risks and benefits of introducing 
smallpox vaccination into a pediatric health care environment. 
This is critically important, since a high percentage of the 
patients we treat at the Children's Hospital of Philadelphia 
are very ill or have weakened immune systems.
    Let me share with you four questions we have posed, and 
some of our thinking to date. The first question: What is the 
risk of exposure to smallpox through bioterrorism? Fortunately, 
there have been no cases of smallpox seen in the world for 
approximately 25 years. Based on our current information, it is 
difficult to ascertain this risk at this time.
    The second question is: What are the risks of smallpox 
vaccination in this hospital environment? To consider this side 
of the equation, what do we know about the vaccine? Well, we 
know that the vaccinia virus, which is the virus used in the 
vaccine, is effective in preventing smallpox. We know that this 
vaccine protects against smallpox if a person is inoculated 
within days after exposure. We know that a person who is 
vaccinated may spread the virus to other people or other parts 
of their own body, and the vaccine certainly has its side 
effects, which have been outlined previously. Persons with 
immune systems that are weakened have a greater risk for these 
adverse events.
    Now, the next question that we think is important, again, 
viewing this from the vulnerable population in a hospital, is: 
What is the risk that vaccinia virus might spread from the arm 
of a health care worker to a hospitalized child? An article by 
Kent Sepkowitz, which will appear shortly in the New England 
Journal of Medicine, reviews the spread of smallpox vaccine 
virus in hospitals from 1907 until 1975. The spread of this 
vaccine virus has been reported 12 times in that interval. 
Eight of the 12 reports of spread within a hospital were in 
children, and in pediatric wards in children's hospitals. Most 
of the time, it is spread by a health care provider who 
transmits the virus on their hands to the patient.
    According to this review, the chance of being infected in 
the hospital could be as high as 10 percent. Nine of the 85 
people who were thus infected by contact died as a result of 
this infection from the vaccine virus, thus, our past 
experience with the vaccine shows that there are, indeed, 
potential risks to this in this vulnerable population within a 
hospital.
    The next and final question is: Are the risks for using the 
smallpox vaccine in 2003 greater than they were in the 1940s 
and 1950s and 1960s? Which is what we are drawing this 
information from, and we think the answer to this question is 
yes. Due to advances in medical treatment, both the risk and 
the risk pool have increased dramatically over the last 20 
years. For example, children and infants are on steroids, they 
are undergoing cancer chemotherapy, they are receiving kidney, 
heart, liver, bone marrow transplantation. All of these 
children are immunosuppressed.
    Second, in general, we are asked to vaccinate into a pool 
of young health care workers who are 30 years old or less, and 
who have not been vaccinated previously.
    Third, in addition to the thousands of sick children that 
we care for, we may have a health care worker who is 
immunocompromised actually in that environment, so therefore, 
weighing these risks and benefits, the Children's Hospital of 
Philadelphia does not currently recommend voluntary smallpox 
vaccinations for its frontline health care workers in our 
institution.
    Senator Specter. Dr. Bell, that is a very important 
conclusion. Would you elaborate why?
    Dr. Bell. Well, again, I think the issue is the vulnerable 
population that we serve, the concerns that, although perhaps 
not high, there is a risk. There is a risk that this virus 
vaccine could infect a severely ill or an immunocompromised 
child within this environment and potentially die.
    Senator Specter. We will come back for more questions in 
the Q and A, but just one follow-up at this point. You say 
because of the clientele you serve. If you were not serving 
children, but were serving adults, would you have a different 
conclusion?
    Dr. Bell. Well, I think that--I am not sure that the risks 
are tremendously different between the very sick adults and 
sick infants. However, with some of the data we have from 
prior, from the 1940s and 1950s and 1960s, it does seem that 
hospitalized children may be at increased risk, given the 
reports and the review of the data.
    Senator Specter. I pursue the question with you because it 
is rather startling an institution of your prestige would 
decline to inoculate.
    Dr. Bell. Well, I think this is a point in time. We are, at 
this moment, declining to do this. This is a very complicated 
issue. I think new data, new changes in what we know about the 
risk from the other side in terms of the risk of being exposed 
to smallpox will be a day-to-day affair in how we process this.

                           prepared statement

    I just want to make a point, though, that this decision in 
no way diminishes our willingness to enlist our hospital staff 
and resources should this unthinkable thing happen. We will be 
there and care for children if this does happen, but at this 
point in time, weighing these risks and benefits, and the risks 
to our patient population, we have made this decision.
    [The statement follows:]
                Prepared Statement of Dr. Louis M. Bell
    Good morning. It's a pleasure to have the opportunity to speak to 
this committee on the complex topic of smallpox vaccination and its 
particular impact on the pediatric hospital population. I am Dr. Louis 
M. Bell, and I have been a practicing pediatrician for almost 20 years. 
I am Division Chief of General Pediatrics at The Children's Hospital of 
Philadelphia and Chair of the Infection Control and Prevention 
Committee at the Hospital. I also hold an endowed chair in pediatric 
medicine at Children's Hospital and am co-author of a book entitled 
``Vaccines: What Every Parent Should Know.''
    I am board certified in both pediatric infectious diseases and 
pediatric emergency medicine. For more than a decade, I have been 
involved in research that has focused on vaccine education and 
improving vaccine delivery to urban children.
    I am here today representing the physicians, nurses, health care 
providers and administrators at The Children's Hospital of 
Philadelphia. I will attempt to summarize a number of issues that we, 
as a Hospital, have been considering in response to President Bush's 
December 13, 2002 call to develop a voluntary pre-event smallpox 
vaccination program.
    The Children's Hospital of Philadelphia is regarded as a world 
leader in pediatrics. We operate the largest pediatric healthcare 
system in the United States, handling more than 770,000 outpatient 
visits each year. On our main campus in Philadelphia, Children's 
Hospital handles more than 20,000 inpatient admissions annually, with 
approximately 65,000 emergency department visits each year. We provide 
primary, specialty and home care services to children and their 
families in more than 40 locations throughout Pennsylvania, New Jersey 
and Delaware.
    In addition, The Children's Hospital of Philadelphia is recognized 
as one of the world's leading pediatric research facilities. We rank 
second among children's hospitals in National Institutes of Health 
funding, making us one of the largest and most prestigious pediatric 
research programs in the nation.
    We are also a national resource, accepting referrals from hospitals 
across the United States, providing specialized cardiac care, fetal 
therapy, cancer treatment, organ transplantation and other specialty 
services to children of all ages, from before birth through young 
adulthood.
    I recite these statistics not to impress the Committee, but rather, 
to help you understand two points. First, that we have some of the best 
minds in pediatric medicine deliberating on this issue. Second, we must 
carefully consider the risks and benefits of introducing smallpox 
vaccination into a pediatric healthcare environment. This is critically 
important since a high percentage of the patients we treat at The 
Children's Hospital of Philadelphia are very ill or have weakened 
immune systems
    Let me share with you some of the questions we've posed and some of 
our thinking to date.
                         medical considerations
1. What is the risk of exposure to smallpox through bioterrorism?
    No case of smallpox has been seen in the world for approximately 25 
years. The only known way to introduce smallpox is through 
bioterrorism. Based on current information, it is difficult to 
ascertain the risks at this time.
2. What are the risks of the smallpox vaccine?
    To consider this from a risk/benefit equation, we can look back to 
previous experiences. What do we know about the vaccine? We know that 
the vaccinia virus, which is the virus used in the vaccine, is 
effective in preventing smallpox. This vaccine protects against 
smallpox if a person is inoculated within days after exposure. We also 
know that this is a live vaccine that is inoculated on the skin. After 
inoculation, the vaccine virus grows and forms a scab that falls off in 
2 to 3 weeks. As long as the scab is present, the person who is 
vaccinated may spread the virus to other people or to other parts of 
their body. The vaccine has its side effects, which are most severe in 
those who have never been vaccinated previously. In addition, persons 
whose immune systems are weakened or have eczema are at even a greater 
risk of adverse outcomes.
    Perhaps the most important question remains . . .
3. What is the risk that the vaccinia virus might spread from the arm 
        of the health care worker to a hospitalized child?
    An article by Dr. Kent Sepkowitz, which will appear shortly in the 
New England Journal of Medicine, reviews the spread of the smallpox 
vaccine in hospitals 12 times between 1907 and 1975. Eight of the 12 
reports involved hospitalized children. A total of 85 children and 
adults were infected by health care providers who transmitted the virus 
on their hands. According to this data, the chance of being infected in 
the hospital could be as high as 10 percent. In fact, nine of the 85 
people (11 percent) died as a result of the smallpox vaccine. Thus, our 
past experience with the vaccine shows that there are potential risks 
to its use.
4. Are the risks for using the smallpox vaccine in 2003 greater than in 
        the 1940s, 1950s and 1960s?
    We think the answer to this question is yes. Due to advances in 
medical treatment, both the risks and the risk pool have increased 
dramatically over the last 20 years. For example, children and infants 
on steroids, undergoing cancer chemotherapy, or receiving kidney, 
heart, liver or bone marrow transplantations are immune suppressed. 
Second, in general, we are vaccinating health care workers who are less 
than 30 years old and have never been vaccinated previously. Third, in 
addition to the thousand of sick children treated by our Hospital, we 
have healthcare workers who are also immunocompromised.
    Therefore, after carefully weighing these risks against the 
benefits, The Children's Hospital of Philadelphia does not currently 
recommend voluntary smallpox vaccinations for its frontline healthcare 
workers. This decision is based on thorough analysis of all available 
data, taking into account concerns about the safety and side effect 
profile of the vaccine for our staff as well as the potential impact on 
our patient population.
    As a tertiary care pediatric medical center, a high percentage of 
our young patient population is immunocompromised. We are concerned 
that the introduction of newly vaccinated healthcare workers could 
expose our patients and employees to unnecessary risks.
    We recognize that this is a complicated issue. Our policy will 
continue to be evaluated and assessed against new data, scientific 
advances such as the development of a new generation of smallpox 
vaccine and changes in world events.
    Lastly, we wish to emphasize that this decision in no way 
diminishes our willingness to enlist our hospital staff and resources 
should the unthinkable happen and there is a smallpox outbreak in the 
Philadelphia area.
                       operational considerations
    In addition to the medical issues raised above, healthcare 
institutions must also consider a number of operational impacts.
    1. Who will bear the medical cost of treating adverse reactions to 
the smallpox vaccine in health care providers who volunteer to be 
vaccinated?
    2. Taking into account that introducing the vaccine virus into a 
population of hospitalized children carries increased risk, should 
different consideration be given to pediatric institutions?
    3. Should administrative leave be granted for health care workers 
in children's hospitals who volunteer to be vaccinated?
    4. In addition to these considerations, we recommend that a 
centralized database collect information about adverse reactions which 
occur nationwide as a result of smallpox vaccination. This data should 
be made public.
                               conclusion
    Mr. Chairman, we share the administration's concern that the 
possibility of smallpox as a weapon of bioterrorism is real. We expect 
to participate fully in keeping this country safe. In our daily work as 
physicians and scientists, we carefully weigh the risks and benefits of 
keeping our patients safe.
    The issue of smallpox vaccination presents a complicated picture of 
risks that needs further clarification. We hope that our testimony will 
provide government policymakers and other healthcare institutions 
additional insight into the specific medical risks and operational 
impacts of smallpox vaccinations at pediatric hospitals.
    Mr. Chairman, I am ready to respond to any questions the Committee 
might have.

    Senator Specter. Thank you, Dr. Bell. Stand by. There will 
be some more questions for you.
STATEMENT OF PATRICK LIBBEY, EXECUTIVE DIRECTOR, 
            NATIONAL ASSOCIATION OF COUNTY AND CITY 
            HEALTH OFFICIALS
    Senator Specter. We turn now to Mr. Patrick Libbey, 
executive director of the National Association of County and 
City Health Officials. He had been director of the Thurston 
County Public Health and Social Service Department in Olympia, 
Washington. B.A. from Evergreen College in Washington State.
    Thank you for joining us, Mr. Libbey, and we look forward 
to your testimony.
    Mr. Libbey. Thank you. Good morning, Mr. Chairman, members 
of the committee. As noted, I, up until 5 months ago, had 
served as the director of a local health department in 
Washington State for the past 17 years. I thank you for the 
opportunity to address the committee from the perspective of 
the actual point of implementation of the smallpox vaccination 
program.
    Ultimately, all vaccinations will be given at a community 
level, most often by your local public health system. We are 
committed to successfully preparing the Nation for a smallpox 
outbreak, but success needs to be defined particularly in the 
first stage--this first phase--as being ready to appropriately 
respond to an initial smallpox case and being ready to rapidly 
begin vaccinating in greater numbers other first responders or 
the whole population if the assessment of threat is 
significantly increased, or should a case occur.
    We believe it is prudent to assure that there is a ready 
capacity of voluntarily pre-immunized people to perform disease 
investigation and containment, and able to treat an initial 
case, and ready to begin vaccination of a larger circle of 
people, up to and including the entire population.
    Success also means that clinician expertise and community 
awareness about smallpox disease and vaccination is improved, 
and that disease surveillance is in place that can rapidly 
detect and respond in the event of an outbreak.
    We also believe it is unfortunate that numerical goals, the 
use of 500,000, the use of 10 million as figures, which were 
simply earlier planning projections, appear to have replaced 
these true measures of what successful implementation of this 
first stage ought to be. It really should be a simple question: 
Are we ready, in the event a case is discovered, or if there is 
significant increase in the announcement relative to the 
threat?
    I also am here to say, smallpox vaccination is 
fundamentally different from any of our other current 
vaccination efforts. It is not like lining people up in a mall 
for a flu shot. There are three significant components to 
smallpox vaccination, to actually having the ability to deliver 
and carry this out on a voluntary pre-event basis.
    First is the necessary planning and community preparation. 
This includes the identification and recruitment of vaccinees, 
the community and clinician education, further targeted 
education to specific groups, including emergency medical 
technicians, other first responders, the issues of logistics, 
of receiving, storing, and securing the vaccine, the physical 
logistics, and the list goes on in terms of what is necessary 
to have that community preparation.
    Then there is the actual, clinical delivery of the 
vaccination itself. This is the part that most people see. In 
this vaccination effort for smallpox, it is much more complex 
in the required steps than other vaccinations. Following the 
CDC clinical guidelines for a post-event, there are a number of 
additional steps. Intake is more complex, the informed consent 
process is significantly more involved, a significant amount of 
screening, the administration of the vaccine is fundamentally 
different, and within that clinical setting, having to make 
sure that post-vaccination instructions are given and 
understood.
    Last, there is follow-up. Unlike other vaccinations, 
smallpox will require an extensive follow-up capacity. The 
vaccination site is recommended to be looked at daily, the take 
must be read, there must be an information and triage capacity 
in place to respond to concerns about reactions, and that 
includes both what are within probably normal reactions to 
smallpox, but outside the normal experience of people with 
immunizations, as well as those that would be considered 
adverse, and there must be a clear linkage and established 
referral pattern to treatment services in the event of an 
adverse. We know, by comparison, that these differences from 
other vaccinations are of significance, and we have begun 
costing those.
    Let me just--by comparison, your flu clinic, for example, 
requires virtually no significant amount of community 
preparation, other than generally making it known and 
available, promoting its availability, and there is no 
significant follow-up system. A well-run, planned flu clinic, 
you will have a patient enter and exit in a matter of very few 
minutes. Well-run can be as few as 5. The same for an emergency 
mass immunoglobulin clinic in the event of an outbreak of 
hepatitis A in a community.
    The smallpox clinic, on the other hand, requires the 
extensive community preparation, the follow-up capacity, and 
the much more complex vaccination phase. Three weeks ago, the 
Arlington County Health Department, at the request of the 
Secretary's office, conducted a mock clinic, vaccinating 1,000 
persons, using the CDC clinical guidelines, and this was 
reviewed by an HHS-selected time-motion consultant.
    It took about an hour for a potential vaccinee from the 
point of entry to the point of exit to go through those 
necessary steps. Compare that, again, to the notion of being in 
and out of a flu in a matter of 5 minutes or fewer. That also 
includes the 30 percent of people, by virtue of the system, 
that were screened out that were not appropriate to be 
vaccinated.
    With all respect to Dr. Gerberding, I must respectfully but 
strongly disagree with her assessment of the cost of doing this 
business. At CDC's request, we have been costing these stages. 
This is our business. This is what your local health 
departments do. We have the expertise in organizing and 
conducting vaccination efforts. We have now cost projections 
from four large metropolitan areas throughout the country. 
Taking these particular stages apart, and comparable 
activities, cost range currently for all three stages runs from 
a low of $142 to a high of $222.
    In Arlington County, the mock clinic that I had mentioned, 
for the vaccination stage only, not even setting it up, not the 
pre-community or post-follow-up, the costs that they came out 
of that with, reviewed by their HHS consultant, was about $100 
per person through that.
    What you see when you get a vaccination, and what it takes 
to do a vaccination, are not the same, and it is very easy for 
us to think from our own vaccination experience.
    I must also tell you that local health departments are 
diverting staff and funding from other bioterrorism 
preparedness efforts to work almost exclusively on smallpox 
vaccination. We know from a recent survey that local public 
health departments have made significant progress over the last 
year in improving their overall readiness, and most of this, 
frankly, can be attributed to the Federal resources that you 
collectively have made available to improve that readiness in 
the 16 critical areas Dr. Gerberding mentioned.
    Senator Specter. Mr. Libbey, you are 2 minutes over. Could 
you summarize, please?

                           prepared statement

    Mr. Libbey. I can. Two things I would say in conclusion. We 
are, in fact, diverting our bioterrorism resources, leaving us 
less prepared, and probably regressing in the progress we have 
made, and we are also starting to clearly see a number of 
communities that other public health plans, including chronic 
disease screenings, cancer screenings and the like, we are 
starting to draw resources from that to be able to speak 
specifically to smallpox. We need to progress. We need to do 
it, stay small, go slow, and assure that we have the resources 
to do it appropriately.
    Thank you.
    [The statement follows:]
                Prepared Statement of Patrick M. Libbey
    Good morning, Mr. Chairman and members of the subcommittee. I am 
Patrick M. Libbey. I am Executive Director of the National Association 
of County and City Health Officials (NACCHO). NACCHO is the 
organization representing the almost 3,000 local public health 
departments in the country. Before beginning work here in Washington, 
DC last year, I served as NACCHO's President and was Director of the 
Thurston County, Washington, Department of Health and Social Services 
for 17 years. I have been deeply engaged in bioterrorism preparedness 
at both the local and federal levels. I am here today to explain the 
challenges faced by local public health agencies in implementing the 
President's smallpox vaccination program and what resources we believe 
are needed to meet those challenges.
    NACCHO and its members are committed to doing everything within our 
power to achieve success in preparing the nation for an outbreak of 
smallpox, should that terrible event ever occur. Our definition of 
success is that the nation will have the ability to identify a smallpox 
outbreak as soon as possible, to ramp up and vaccinate as many persons 
as necessary to contain an outbreak, and to vaccinate voluntarily every 
medically eligible United States resident in a safe and timely manner 
should that become essential to save lives. The Department of Health 
and Human Services (HHS) has recognized that the plans and systems 
needed to achieve this success will vary greatly among states and 
localities. We fully concur with this approach. Therefore, we believe 
that success will not be measured in terms of numbers of persons 
vaccinated in the coming months. Rather, success will be measured by 
the ability of states and localities to demonstrate that there is a 
workable, tested plan in place to contain any smallpox outbreak, and 
sufficient numbers of public health and medical care personnel 
vaccinated to provide care for the initial cases, to do the 
epidemiologic footwork that will be necessary to identify persons who 
have been in contact with infected individuals, and to be the first 
vaccinators in a mass vaccination campaign.
                   smallpox vaccination is different
    We in public health have long experience in successfully mounting 
immunization campaigns to prevent such diseases as polio, measles, 
influenza, or Hepatitis A, in both routine and emergency circumstances. 
Smallpox vaccination, particularly in the absence of any known cases or 
known threat, is different. The live virus vaccine carries risks of 
side effects that are greater and more serious than the risks of any 
other vaccine we use. The only purchaser of the vaccine is the federal 
government. Planning, implementing, and evaluating a national smallpox 
vaccination program in a way that maximizes effectiveness and minimizes 
risk to individuals therefore involves many more components than 
routine immunization programs. There is much more to it than lining 
people up in a mall to get their flu shots.
    A smallpox vaccination program has three basic components. The 
first is community preparation, which involves planning, training, and 
community education. Many local public health agencies are assisting 
their states in identifying who should be vaccinated. This has involved 
intensive work both with public health staff and with hospitals and 
other health care providers, as well as the general public. The needs 
for education and information have been great. Planning a vaccination 
clinic includes components that would be expected for any such 
enterprise--identifying and arranging for a site, for security, for 
managing the flow of people, for staffing, for transportation and 
storage of vaccine and supplies, and for record-keeping. However, the 
novel and riskier nature of smallpox vaccination requires additional 
steps that take time and resources. There must be a communication plan 
to inform the community and the media about what is taking place. 
Existing information technology systems may require modification to 
handle special requirements for follow-up of persons vaccinated and 
reporting, tracking and management of adverse events.
    The second component is actual administration of the vaccine. The 
Centers for Disease Control and Prevention (CDC) has promulgated 
guidelines for post-event smallpox vaccination clinics and this model 
is being adapted for pre-event smallpox vaccination now. According to 
these guidelines, the personnel required at a clinic site include: a 
registration staff; a patient education staff to provide the 
information and obtain the documentation necessary to assure informed 
consent; medical screeners to review each prospective vaccinee's 
medical history forms and interview each person; medical assistants to 
prepare the vaccine and keep supplies at hand; persons trained to 
administer the vaccine and observe for any immediate reactions; 
administrative staff to assure proper record-keeping; staff to direct 
people and control clinic flow; security staff; and emergency medical 
personnel to address any serious medical events that might take place. 
All of these people must be trained in advance to conduct their jobs 
safely and effectively. The Arlington County (Virginia) Public Health 
Department recently conducted a mock clinic according to these 
guidelines and HHS is working on an evaluation so that the guidelines 
can be improved. That clinic required 80 staff on-site to serve 90-100 
prospective vaccinees per hour for eight hours.
    The third stage is post-vaccination follow-up and evaluation. The 
job is not over when a person has been pricked by a bifurcated needle 
15 times. The Advisory Committee on Immunization Practices recommends 
daily checks of the vaccination sites of health care workers to assure 
the site is properly dressed, to check for a proper take, and to spot 
any swelling, rash, or other adverse reaction. We also fully expect 
that a certain number of ``worried well'' who are vaccinated will 
request follow-up assessments. It is therefore necessary to plan for 
and designate staff to assess vaccination takes and assess or refer 
suspected adverse events. In addition, there must be a plan for 
obtaining and distributing vaccinia immune globulin (VIG), which is 
used to treat adverse reactions, and a cadre of medical professionals 
trained to diagnose and treat adverse reactions.
 impact of smallpox vaccination program on local public health agencies
    Implementing a smallpox vaccination program with all these 
components and complexities is a tall order indeed. We believe it can 
be done, given sufficient time and resources. State and local public 
health agencies, working with hospitals and physicians, are doing it 
now and we will continue. However, the crush of the current smallpox 
vaccination activity is taking a large toll on public health agencies. 
We do not believe it can be sustained without serious harm to a public 
health system that has already redoubled its efforts in order to 
improve the national's overall public health preparedness.
    NACCHO is monitoring the local experience with smallpox vaccination 
and conducted a brief Web-based survey last week to determine how the 
program has affected local public health agencies thus far. We received 
responses from 718 agencies, representing a broad range in terms of the 
size of population served, from under 20,000 to large metropolitan 
areas. A positive finding was that 37 percent of the respondents 
indicated that smallpox or other bioterrorism preparedness work is 
enhancing their other public health activities. We believe that this is 
because public health preparedness requires building new relationships 
and devising new ways of working within the community. Such new 
relationships--with hospitals, physicians, emergency responders--
improve the effectiveness of other public health activities, too.
    However, more than half (58 percent) reported that smallpox work is 
hurting their other bioterrorism preparedness efforts. Some agencies 
never received bioterrorism preparedness funding and therefore are 
spending other funds for smallpox vaccination. Others are rapidly 
spending down their bioterrorism funding on smallpox vaccination, 
rather than using it to fulfill many other requirements for 
bioterrorism preparedness described in CDC's cooperative agreements 
with the states. Our survey respondents were especially concerned about 
preparing to fulfill the public health role in responding to acts of 
terrorism using other agents, such as anthrax, ricin, or nuclear 
materials. This information confirms our concern that the emphasis on 
smallpox vaccination is indeed beginning to compromise our ability to 
prepare for other acts of terrorism. We are losing the most important 
potential of bioterrorism preparedness funding, which was to help 
states and localities build the capacities needed to address multiple 
public health threats.
    It is equally alarming to us that more than one-third (35 percent) 
of the survey respondents reported that smallpox already is negatively 
affecting other public health programs. Public health clinics that 
provide such services as childhood and influenza immunizations have 
been deferred, delayed, or canceled in 182 jurisdictions due to the 
demands of smallpox vaccination. Staff members who worked in 
communicable disease control are now focusing exclusively on smallpox, 
causing work such as control of tuberculosis and sexually transmitted 
diseases to lag. It is important to note that these negative impacts 
occurred even before a single person was vaccinated. We are gravely 
concerned that, if diversion of general public health resources to 
smallpox vaccination continues and grows, our communities will become 
more vulnerable to ongoing public health threats. We will compromise 
our ability to prevent and respond to influenza, childhood diseases, 
West Nile virus, contaminated drinking water, food-borne illness, and 
chronic diseases.
                     costs of smallpox vaccination
    Early estimates of the cost of smallpox vaccination to state and 
local governments were about $85 per person. We are now beginning to 
assess actual cost data, obtained from a small sample of jurisdictions 
using a template that ensures that the costs are comparable. We have 
available current estimates from four large urban public health 
agencies. The costs per vaccine are $142, $155, $177 and $220. They 
include all planning, training, communication, data management, clinic 
implementation and follow-up costs. We believe that this cost range is 
more realistic than smaller numbers that address clinic costs only. The 
Arlington County Health Department's cost per person for implementing a 
mock smallpox vaccination clinic using CDC's guidelines was about $100, 
a figure that does not include any of the planning and community 
preparation component or post-vaccination follow-up.
    If it became necessary to vaccinate a much larger group of persons 
than the initial public health and medical care response teams, certain 
fixed costs, such as planning and epidemiologic surveillance, would not 
change much and would be spread over a larger number of individuals. 
Other costs, such as staff time at clinics, might increase because more 
intensive education and screening would likely be required for 
vaccinees who are not already trained public health or medical 
personnel.
    We expect to obtain more extensive cost data as the smallpox 
vaccination program moves forward and will be pleased to share our 
information with the Committee. There clearly will be differences in 
cost among states and localities. However, we believe we have 
sufficient information now to demonstrate that smallpox vaccination 
costs are high, certainly far higher than $10 or $20 per person, and 
that state and local governments do not have the resources to bear 
these costs for much longer.
    Many local public health agencies are reporting that the amount of 
federal bioterrorism funds made available to them, if any, no longer 
covers the costs of what is expected now to vaccinate public health and 
medical teams, let alone any expanded number of vaccinees. Redirecting 
all our bioterrorism funds to smallpox halts our progress in 
bioterrorism preparedness and leaves us increasingly vulnerable to 
other agents. It is also detracting from ongoing local public health 
work to protect and provide service to local communities. We strongly 
urge the Committee to heed these reports from actual local public 
health practice and provide state and local health departments and 
other parties who must also bear these costs with the funds to fulfill 
the President's mandate.
    There are many other current obstacles to successful implementation 
of smallpox vaccination. I have attached a statement presented on 
NACCHO's behalf to the Institute of Medicine Committee on Smallpox 
Vaccination Implementation on December 19, 2002 that addresses other 
issues of great importance.
    Chairman Specter and Senator Harkin, you have been leaders in 
providing funding for public health preparedness and in recognizing 
that local public health departments serve on the front lines in 
battling public health crises of all types. We are grateful for your 
continuing support. I will be happy to answer any questions you have 
and to provide whatever other available information you may wish for 
the record. Thank you.

Attachment.
 statement of patrick libbey, executive director, national association 
  of county and city health officials, presented to the institute of 
  medicine committee on smallpox vaccination program implementation, 
                           december 19, 2002
    On behalf of the National Association of County and City Health 
Officials (NACCHO), I thank you for the opportunity to provide initial 
comments on the national smallpox vaccination program from the 
perspective of local public health agencies. This program has multiple 
practical complexities. We expect that new questions and concerns will 
continue to arise as states and localities gain experience. We look 
forward to working with the Committee on a continuous basis to identify 
new issues and lessons learned as implementation proceeds.
    NACCHO represents the nation's nearly 3000 local public health 
agencies. Many will be involved in planning and implementing smallpox 
vaccination in their communities, particularly as the program extends 
into its second phase of vaccinating up to ten million first 
responders, as the President has announced. This program has serious 
and far-reaching implications for local public health practice. Our 
message, based on the classic admonition, ``First, do no harm,'' is 
straightforward. It is, ``Slow down and stay small.''
    We all must respect the sense of urgency conveyed by the President. 
However, we also believe that, in light of the President's statement 
that there is no imminent risk of a smallpox outbreak, we owe it to our 
communities to proceed carefully and take the time to evaluate our 
vaccination activities as we go. We must also understand and document 
clearly the consequences of the necessary diversion of resources from 
other critical public health work to smallpox vaccination.
    localities need more assistance and flexibility in implementing 
                          smallpox vaccination
    Planning is well underway for the initial phase of vaccinating 
500,000 volunteer medical and public health response teams. Local 
public health agencies that will play a role in this phase are 
encountering many questions. Among these are the presence or absence of 
liability protection for entities engaged in vaccination and the 
availability of compensation for vaccinated persons who lose work time 
or incur medical care costs as a consequence. The Homeland Security Act 
and state workers' compensation laws do not adequately address these 
concerns, which remain substantial barriers.
    Local public health agencies also need consistent guidance in 
several areas. They need accurate, uniform guidelines for clinical 
practice. They need guidance for communicating with potential 
vaccinees. They need guidance for communicating with their communities, 
particularly in explaining the program as the President has established 
it and in explaining the particular course of action that their state 
has adopted. It is appropriate and expected that state plans for 
initial vaccinations will vary, but it is essential that local public 
health officials be able to explain why the types and numbers of people 
who will be asked to volunteer for vaccination vary markedly among the 
states.
    It is also essential that the federal government take the time to 
evaluate the initial experience of vaccination. This should include: 
monitoring side effects; identifying unexpected logistical barriers to 
vaccination; consulting more thoroughly with the next larger cohort to 
be vaccinated; and instituting measures for quality assurance. CDC has 
undertaken a training program that relies on distance-based training 
and a ``train the trainer'' model for administering vaccinations. It is 
essential to evaluate the effectiveness of that training, so that there 
is greater assurance that vaccines are administered and ``takes'' are 
evaluated properly. We do not believe it will be appropriate for any 
community to move forward with vaccinating a larger population until we 
have identified what training methods are effective and implemented 
them to prepare the larger number of vaccinators that will be required.
implementation of vaccination of up to 10 million first responders will 
           take more time and resources than are now planned
    The logistics for vaccinating the first 500,000 volunteers 
nationally remain incomplete, but we are confident that states and 
localities can master them. However, those same plans and logistics 
will not work when the objective expands by a factor of 20 to encompass 
up to 10 million first responders. The broader program cannot be 
successful unless we take the time not only to apply the lessons 
learned in the first phase of the program, but also to tackle 
significantly greater logistical problems. We have only begun to 
identify the potential issues. These include: Who will provide 
vaccinations and how will they be indemnified? How do we get vaccine to 
a larger group of vaccinators and assure its proper storage, handling 
and administration? How do we train vaccinators? How do we ensure that 
emergency and routine first responders can be vaccinated without 
disrupting essential community services? Local public health agencies 
have long experience in mounting immunization programs, but the unique 
characteristics of the smallpox vaccine raise a host of new questions. 
We must take the time to answer them before we can expect to launch an 
effective vaccination program.
    We also need to assess the costs of such a program. We know that 
they will be great. States and localities already are diverting 
significant resources to smallpox vaccination and there is no endpoint 
in sight. We are greatly concerned about two effects of such a 
diversion. First, staff hired through the state and local grants for 
bioterrorism preparedness cannot also pursue the other important 
preparedness activities that are now underway. We already see these 
activities slowing or halting in many locations. A disproportionate 
amount of resources may be spent on smallpox vaccination for an 
indefinite time, at the expense of other bioterrorism and emergency 
preparedness programs.
    Second, the magnitude of a program to vaccinate ten million 
persons, and possibly also other members of the general public, will 
drain general public health resources at an alarming rate for an 
unknown period of time. In some jurisdictions, new staff have been 
hired with federal bioterrorism preparedness funds because they have 
the skills to improve public health capacities in the five focus areas 
of the cooperative agreements, including epidemiology, communication, 
and the application of information technology. These staff cannot 
readily be transferred into smallpox vaccination, which requires a 
different set of competencies. In many other jurisdictions, existing 
staff has taken on the additional job of preparing for bioterrorism. In 
either case, it is inevitable that existing staff in maternal and child 
health, immunization, or other clinical programs will be diverted even 
more into smallpox vaccination. This will further disrupt essential 
community services. We recommend a more measured, thoughtful 
implementation, whereby the capacity for smallpox vaccination is 
incorporated more gradually into routine public health practice. We 
cannot afford to exact a sudden, dramatic toll on routine disease 
prevention and health promotion activities.
          the scope of smallpox vaccination should be limited
    We have grave reservations about offering smallpox vaccination on 
demand to members of the general public, in the absence of a heightened 
threat assessment. Smallpox vaccine is inherently less safe than 
immunizations we advocate and offer routinely. We are greatly concerned 
about both inflicting harm unnecessarily and compromising our 
effectiveness in routine immunizations. Adverse reactions to smallpox 
vaccine will be well publicized and we would expect such publicity to 
have a chilling effect on both childhood and adult immunization 
efforts. Our best chance to minimize this effect is to limit explicitly 
the use of smallpox vaccine, thereby distinguishing it from routine 
immunizations, and to ratchet up our ongoing public education about the 
relative risks and benefits of routine childhood and adult 
immunization.
    For all these reasons, we urge a slower, measured approach to 
smallpox vaccination. We urge that the program be kept at minimal 
levels and grow only as rapidly as threat assessment demands, so as not 
to disrupt other basic community health protections or cause 
unnecessary harm.

    Senator Specter. Thank you very much, Mr. Libbey.
STATEMENT OF JAMES AUGUST, DIRECTOR, HEALTH AND SAFETY, 
            AMERICAN FEDERATION OF STATE, COUNTY, AND 
            MUNICIPAL EMPLOYEES
    Senator Specter. We now turn to Mr. James August, director 
of Health and Safety for the American Federation of State, 
County, and Municipal Employees. In that position, he oversees 
the development of training on the identification and control 
of chemical, biological, ergonomic safety and security hazards 
in the workplace. Master of public health from the University 
of California at Los Angeles.
    Thank you for joining us, Mr. August, and we look forward 
to your testimony.
    Mr. August. Mr. Chairman and members of the committee, I am 
James August, and I direct the occupational health and safety 
program for the American Federation of State, County, and 
Municipal Employees, a labor union of 1.3 million members, 
including over 350,000 health care workers and first 
responders. We appreciate the opportunity to address a matter 
of great importance to our members, their families, coworkers, 
and patients.
    Earlier this month, AFSCME president Gerald McEntee and 
other union leaders called on President Bush to delay 
implementation of the smallpox vaccination plan until a number 
of very serious safety concerns and workplace issues are 
resolved. I will quickly summarize our concerns, and I have 
submitted more extensive written testimony for the record.
    It is our position that the vaccination program should be 
delayed until a comprehensive plan is implemented with the 
following safeguards, many of which mirror what is being done 
in the military smallpox plan. Prior to receiving the vaccine, 
workers must be educated about the risks of vaccination to 
themselves and the potential for transmitting the vaccinia 
virus to patients, family members and other contacts. Workers 
must not be pressured in any way into volunteering by their 
employers, and there must be no reprisals against workers who 
decline to be vaccinated for any reason.
    Given the potential serious side effects of smallpox 
vaccine which others have described, workers must be carefully 
screened. Prevention is extremely important here. Those who 
might have a contraindication for the vaccine must be offered 
free and confidential medical testing. There must be vigilant 
medical surveillance following vaccinations to rapidly respond 
to adverse reactions. Workers must have access to necessary 
medical treatment, including the availability of VIG.
    The Food and Drug Administration needs to quickly approve 
the use of bifurcated needles with a built-in safety feature to 
administer the vaccine, consistent with the Needle Stick Safety 
and Protection Act which Congress passed in 2002. It is 
absolutely crucial that public health systems be provided 
resources to safely implement a vaccination program, and should 
not be forced to divert funds from core public health programs, 
as the previous witness described.
    As you know, the States are facing their worst fiscal 
crisis since World War II. The challenges and risks of the 
smallpox program are far too great to impose on State and local 
health departments and hospitals without additional funding.
    Last, I will address the compensation issue, which I was 
specifically asked to comment on. In short, State and Federal 
Worker's Compensation programs do not provide an adequate 
safety net. Some Worker's Compensation programs may not cover 
claims of workers who have an adverse reaction because they 
have volunteered to be vaccinated.
    Some State Worker's Compensation programs do not require 
coverage for all workers. Other States exclude, or permit 
exclusion of self-employed workers, which is a particular 
concern in hospitals that rely on self-employed agency and 
contract workers, and since Worker's Compensation only applies 
to injuries that are work-related, a household member or a 
patient who becomes sick or disabled from the vaccinia due to 
contact with a vaccinated worker will not be eligible for any 
benefits at all.
    Now, even where Worker's Compensation is applicable, 
workers will not be fully compensated. Most programs replace 
only two-thirds of workers' earnings. There are also limits on 
the maximum weekly benefits, which means the more highly 
compensated health care workers cannot receive anything 
approaching adequate replacement of their lost income. Also, 
due to waiting periods, Worker's Compensation will not apply to 
the estimated one-third of workers who will have a reaction 
that will make them too ill to work from one to a few days. In 
addition, there are caps on medical care, posing a particular 
problem for workers who suffer a severe side effect.
    In short, Worker's Compensation programs will not provide 
the compensation and medical care that injured workers or 
individuals made ill by contact with vaccinated workers would 
need and deserve.
    The Federal Government has initiated the vaccination 
program to protect the country against an intentional release 
of smallpox. It is unacceptable to ask health care and 
emergency workers to volunteer to be on the front lines in the 
defense of the Nation and at the same time tell them that if 
they or their family members are harmed by the vaccine, they 
are on their own regarding medical care and compensation. 
Therefore, it is necessary and appropriate for the Federal 
Government to establish uniform protections.
    The National Vaccine Injury Compensation Program for 
children is an adaptable model for a Federal no-fault smallpox 
compensation program. It must be easy to access, provide prompt 
payment, and fully reimburse affected individuals with respect 
to income and medical costs.
    In conclusion, the current smallpox vaccination program 
raises a number of serious safety and workplace problems. The 
prudent course of action at this time is to pause, look at the 
problems more closely, and then let us correct the problems 
that exist. We are eager to assist in designing a program that 
protects the Nation and addresses the concerns of frontline 
health care and public safety workers.

                           prepared statement

    Thank you for allowing me to present our views on this 
important matter and, at the appropriate time, I would be 
pleased to answer any questions you may have.
    [The statement follows:]

                   Prepared Statement of James August

    I am James August and I direct the Occupational Health and Safety 
program for the American Federation of State, County and Municipal 
Employees (AFSCME), a labor union of 1.3 million members. AFSCME 
represents over 350,000 health care workers and first responders, many 
of whom will be asked to receive the smallpox vaccine in the coming 
months under the vaccination program launched last week. I appreciate 
the opportunity to address a matter of great importance and urgency to 
our members, their families, coworkers and patients.
    AFSCME has closely monitored the development of the Centers for 
Disease Control and Prevention's (CDC) Smallpox Response Plan, 
particularly the evolution of the smallpox vaccination component. In 
the fall of 2001, the plan called for inoculating 150 CDC staff, who 
would investigate and respond to a confirmed or suspected case(s), and 
initiate a vaccination program anywhere in the country within twelve 
hours. There was widespread opinion that such a small number of 
vaccinated medical personnel employing the ring vaccination strategy 
used during the worldwide smallpox eradication effort would not be 
sufficient in this modern and mobile society, particularly if smallpox 
was intentionally released simultaneously in multiple locations. At the 
June 2002 Institute of Medicine (IOM) meeting to examine the risks and 
appropriate responses to a smallpox attack, CDC and other government 
agencies involved in bioterrorism response planning were discussing the 
need to vaccinate between 10,000 and 20,000 health care workers. In 
October 2002, the Advisory Committee on Immunization Practices (ACIP) 
recommended that approximately 500,000 health care workers be 
vaccinated. Near the end of last year, President Bush called for 10 
million additional health care and emergency workers to be vaccinated 
in a second wave.
           the need to delay the smallpox vaccination program
    AFSCME agrees with the Institute of Medicine Committee's statement 
that: ``Given this profile of high vaccination risk and likely very low 
to zero benefit, the administration's policy to offer vaccination to 
public health, medical, and emergency workers must be implemented in a 
most prudent and cautious manner.'' Earlier this month, AFSCME 
President Gerald W. McEntee and other union leaders called on President 
Bush to delay implementation of the smallpox vaccination plan until a 
number of serious safety concerns and workplace issues were 
satisfactorily resolved. Local unions and nurse associations in a 
number of states, including AFSCME's Local 1199 in Philadelphia, are 
recommending that their members not volunteer to participate until 
these issues are addressed. AFSCME recognizes the need to prepare the 
nation for a range of possible biological attacks. However, we have 
grave concerns that the smallpox vaccination program is being 
implemented without a comprehensive and federally funded plan that will 
ensure that the vaccinations are administered safely and that those who 
suffer adverse effects from the vaccination and exposure to the 
vaccinia virus will receive compensation and medical care. The absence 
of a federally funded, comprehensive approach to the civilian 
vaccination program is in stark contrast to the Department of Defense's 
more thorough program for the military.
protecting smallpox responders and the public during implementation of 
                              the program
    The vaccination program should be delayed until a comprehensive 
plan is designed and implemented with the following safeguards.
  --Vaccinations should be administered only with full and informed 
        consent.
  --Prior to receiving the vaccine, workers must be trained about the 
        risks and benefits of vaccination to themselves, as well as the 
        potential for and consequences of transmitting the vaccinia 
        virus to patients, family members and other contacts. 
        Educational information must also be made available to family 
        members of potential vaccination volunteers.
  --Workers must be informed about the availability of compensation, or 
        lack thereof, in the event of side effects that require time 
        from work. Workers must also be informed about the availability 
        of medical care in the event of an adverse reaction.
  --Potential responders should be fully informed of their job 
        responsibilities in the event there are smallpox cases.
  --Workers should not be pressured into volunteering by their 
        employers, and there should be no discrimination or reprisals 
        against workers who decline to be vaccinated for any reason. In 
        addition, there must be no discrimination against workers who 
        experience an adverse reaction to the vaccinia.
  --Given the well-known and serious side effects of the smallpox 
        vaccine, workers must be carefully screened, including an 
        interview with an appropriate health care professional. Those 
        persons who might have a contraindication for the vaccine must 
        be offered free and confidential medical testing.
  --There must be vigilant active medical surveillance following 
        vaccinations to rapidly identify and respond to adverse 
        reactions. Workers must have access to necessary medical 
        treatment, including the availability of Vaccinia Immune 
        Globulin (VIG). There must also be surveillance and medical 
        treatment available to those who suffer accidental transmission 
        of the vaccinia virus from a vaccinated worker.
  --The Food and Drug Administration (FDA) must expeditiously approve 
        the use of bifurcated needles with a built-in safety feature 
        consistent with the requirements of the Needlestick Safety and 
        Protection Act of 2000. The needles included in the smallpox 
        kits being shipped to the states do not include an integrated 
        safety feature to prevent needlestick injuries that can 
        transmit bloodborne diseases from patients to health care 
        workers. Safety-designed devices for vaccinations have been 
        approved for marketing by the FDA. However, the safer devices 
        cannot be used by health departments and hospitals until the 
        FDA approves the substitution of safer devices for the unsafe 
        needles included in the smallpox kit.
  the need for new federal resources for implementation in the states
    Public health systems, including state and local health 
departments, hospitals, laboratories, and other entities included in 
the smallpox response plan, must be provided with new and adequate 
federal resources to safely and effectively implement the smallpox 
vaccination program. Adequate funding and requirements for educating, 
screening, monitoring and treating workers must be provided to avoid 
serious vaccine induced adverse effects. Public health departments and 
hospitals should not be forced to divert resources from core public 
health programs or other bioterrorism preparedness activities in order 
to carry out the smallpox vaccination program. When authorizers 
designed requirements for states to receive bioterrorism preparedness 
grants early last year, they did not include requirements for 
implementing a vaccination program. Furthermore, the CDC's Notice of 
Cooperative Agreement Award announcing the requirements for 
biopreparedness grants, issued in February 2002, did not include the 
implementation of a smallpox vaccination program as one of the seven 
activities to be funded under awarded grants. Collectively, states are 
facing a $67 billion budget shortfall for fiscal year 2003 and another 
$60 to $85 billion for fiscal year 2004, the worst fiscal crisis the 
states have experienced since World War II. The costs, challenges, and 
risks of the smallpox program are too great to impose on state and 
local governments without new federal funding.
    inadequacy of compensation and care under workers' compensation
    Congress must address the need for compensation and medical care 
for persons who are injured as the result of receiving the vaccine, or 
individuals who are harmed as a result of contact with a person who has 
been vaccinated. State and federal workers' compensation programs do 
not provide an adequate safety net. In a survey of the states, the 
Association of State and Territorial Health Officials revealed that 
there is great uncertainty about whether workers' compensation will be 
applicable. Indeed, American Insurance Association's chief counsel on 
workers' compensation has declared, ``I do not see where comp would pay 
for either the [smallpox] vaccine or for the adverse effects of an 
inoculation.''----(Business Insurance, January 13, 2003.)
    The gaps in coverage and applicability are significant. Some 
workers' compensation programs may not cover the claims of workers who 
have adverse reactions because they have voluntarily agreed to be 
vaccinated. In a classic Catch-22 situation, one AFSCME local has 
reported that due to the voluntary nature of the vaccination, medical 
expenses resulting from a serious injury will not be covered by the 
workers' compensation program. These same workers have also been 
informed that their health insurance coverage will not apply because 
the injury would be considered work-related. Other states exclude or 
permit exclusion of self-employed workers, a particular concern in 
hospitals that rely upon self-employed, agency and contract workers 
including nurses and emergency room physicians. In Texas, workers' 
compensation is not compulsory for private employers. Finally, since 
workers' compensation only applies to injuries that are work-related, a 
family member or patient who becomes sick or disabled from the vaccinia 
due to contact with a vaccinated health care worker, will not be 
eligible to file claims under state workers' compensation programs.
    Even where workers' compensation plans recognize adverse effects 
from smallpox vaccine as work-related and compensable, workers will not 
be fully compensated. Most state workers' compensation programs replace 
only two-thirds of workers' earnings. The same is true for the program 
covering federal workers who are vaccinated. There are also limits on 
the maximum weekly benefits, which means that more highly compensated 
health care workers cannot receive adequate replacement of their lost 
income. For example, the 2002 maximum weekly payment for Total 
Temporary Disability in California is $490, and only $400 in New York. 
(See www.aflcio.org/yourjobeconomy/safety/wc/upload/unemploy.pdf for 
more information on benefits levels available under state workers' 
compensation programs.) All states have a waiting period before any 
compensation is provided, usually in the range of three to seven days. 
Wages lost during this time will not be compensated unless the worker 
is off work for an extended period, which is typically 14 to 28 days. 
Therefore, workers' compensation will not apply to the estimated one-
in-three workers who will have a reaction that will make them too ill 
to work from one to a few days. In addition, there are caps on medical 
care, posing a particular problem for workers who suffer severe illness 
or injury as a result of the vaccinia. Death benefits also vary widely. 
In Florida, the death benefit is only $103,000, regardless of the size 
of a worker's family or income at the time of death.
    The federal government has initiated the vaccination program to 
protect the country against an intentional release of smallpox. Since 
the smallpox vaccination program is a national effort, there should be 
uniform protections that adequately compensate injured workers. It is 
unacceptable to ask health care and emergency workers to volunteer to 
be on the front lines in the defense of the nation and at the same time 
tell them that if they or their family members are harmed by the 
vaccine, they are on their own regarding medical care and compensation. 
The National Vaccine Injury Compensation Program, for children injured 
by vaccines, provides a model, with adaptation for workers, for a 
federal no-fault compensation system. A smallpox compensation system 
must be easy to access, provide prompt payments, and fully reimburse 
affected individuals with respect to income and medical costs.
                               conclusion
    The President's smallpox vaccination program raises a number of 
serious and unresolved safety and workplace issues. The prudent course 
of action at this time is to pause, carefully examine the problems, and 
correct the deficiencies. We are prepared to assist in designing and 
implementing a program that protects this nation from an intentional 
release of biological agents and that adequately addresses the health, 
safety and livelihood of front line health care workers and first 
responders, their families and their patients.

    Senator Specter. Thank you very much, Mr. August.
STATEMENT OF JANE COLACECCHI, DIRECTOR, IOWA DEPARTMENT 
            OF PUBLIC HEALTH
ACCOMPANIED BY MARY JONES, DIVISION DIRECTOR, EPIDEMIOLOGY, EMS AND 
            DISASTER OPERATIONS, IOWA DEPARTMENT OF PUBLIC HEALTH

    Senator Specter. Our final witness on this panel is Ms. 
Jane Colacecchi, interim director of the Iowa Department of 
Public Health, previously served in the Governor's Office as 
policy advisor to Governor Vilsack, a graduate of the 
University of Southern California, and she is accompanied by 
Ms. Mary Jones, who is the program director of the Office of 
Medical and Public Health Disaster Preparedness in the Iowa 
Department of Public Health.
    Welcome, and the floor is yours.
    Ms. Colacecchi. Thank you. We are here today representing 
Iowa on the need to implement the State's vaccination program. 
Mary Jones is with me, and serves in a leadership capacity for 
the organizational oversight and responsibility for disaster 
terrorism activities within the context of the State's overall 
public health system. She is here today to assist with any 
specific questions you may have on operations.
    We are honored to appear before the subcommittee today, and 
particularly Senator Harkin of Iowa, an important long-time 
advocate for public health. We would like to thank Chairman 
Specter and Senator Harkin for their dedication and commitment 
to securing funding for this important initiative. The Iowa 
Department of Public Health greatly appreciates your 
leadership.
    We are also honored to provide testimony on one of the most 
critical issues facing our Nation, bioterrorism preparedness, 
specifically the smallpox vaccination program. The comments 
that we provide are from the perspective of a State health 
department as it interacts with Federal agencies and with our 
local public health, hospital, and first responder partners.
    In April 2002, Iowa was awarded $11.5 million from the CDC 
to upgrade State and local public health jurisdictions in 
preparedness for and response to bioterrorism and other 
outbreaks of infectious disease and other public health threats 
and emergencies. Additionally, Iowa was awarded $1.3 million 
from HRSA to upgrade hospital, EMS, and other health care 
entities in preparedness for and response to bioterrorism.
    From the CDC and HRSA funds we have allocated at the local, 
regional, and State levels. Through the use of these funds, we 
have established six planning regions for public health and 
health care, with membership from local public health, 
hospitals, EMS, and emergency management. Each region meets 
monthly and is actively engaged in development of regional 
bioterrorism preparedness and response plans.
    We have conducted a series of educational sessions on 
bioterrorism and have held multiple conference calls with local 
public health and hospitals regarding smallpox planning. We 
have implemented a Statewide plan to request and receive 
pharmaceuticals and medical supplies from the Federal 
Government to distribute on a regional basis to local 
communities for public use. We have implemented a 24-7 
emergency notification system for each county health department 
through a Statewide paging system, and we have disseminated 
public information materials on bioterrorism and smallpox 
through a supplement in every newspaper in the State.
    Since December 13, 2003, when President Bush announced his 
policy on vaccination for smallpox and receipt of subsequent 
guidance from the CDC, Iowa has been diligently developing a 
voluntary smallpox vaccination plan and operation procedures 
for public health and health care smallpox teams. No funding 
has been allocated for the smallpox vaccination program. 
Rather, it has been recommended that States redirect funds from 
the CDC bioterrorism cooperative agreement to the smallpox 
vaccination program. As a result, our priority has been changed 
from building a system of multithreat bioterrorism preparedness 
to preparedness for a single biological agent.
    Redirecting of funds from the CDC bioterrorism cooperative 
agreement to develop and implement State smallpox plans will 
affect our ability to build a system of bioterrorism 
preparedness and response by not funding certain critical 
capacities benchmarks and recipient activities. Smallpox 
vaccination planning and implementation is damaging other 
aspects of bioterrorism preparedness, not to mention other 
public health programs, such as prevention and treatment of 
sexually transmitted disease, childhood immunizations, or flu 
immunizations. Without additional resources, some of these 
programs may have to be delayed or canceled to meet the needs 
of the smallpox vaccination program.
    Cost estimates were assembled in an attempt to reflect the 
State's cost to develop and implement the phase 1 pre-event 
smallpox program. It is estimated that the cost per vaccine for 
Iowa is approximately $400. This cost includes all associated 
costs, and is not limited to just the administration of the 
vaccine.
    This includes program development, coordination, 
management, including education, training, adverse event 
surveillance, data management reporting, statistical service, 
public information and education, pre-vaccination screening, 
volunteer interviewing to exclude from vaccination those with 
contraindications, education, collecting demographic data and 
medical data and screening interviews, vaccine and vaccination 
clinics, which includes vaccine receipt distribution, stockpile 
management, storage, vaccination administration, providing 
bandages, supplies to volunteers, clinic set-up and operations, 
staffing, record-keeping, and security, with vaccinators, with 
initial vaccinator training and education materials, salary, 
travel, lodging to staff clinics, volunteer vaccines, or 
reimbursement volunteer salaries for vaccination time and 
vaccine take check time, and then adverse events, both direct 
and indirect costs of complications of smallpox vaccine for 
adults.
    Iowa is developing 15 health care smallpox teams, six 
regional and public health smallpox response teams, with an 
estimated total vaccine plan of approximately 1,000 public 
health and health care workers for the phase 1 program, for a 
total cost of $400,000.
    Vaccination is expected to arrive in Iowa by the end of 
this week. Vaccinator training is scheduled for February 3 
through 4 of 2003, with clinics to commence at the end of 
February. It should be noted that cost estimates for the 
program will be reduced in subsequent phases, as some 
activities will become maintenance or not be necessary.
    We must not lose sight of our mission to build a 
comprehensive system of public health and health care 
preparedness for and response to bioterrorism, outbreaks of 
infectious disease and other public health threats and 
emergencies. It is critical that we sustain the mission of 
building public health and health care infrastructure, 
personnel systems, response capacity, and training for 
bioterrorism. By sustaining the development and implementation 
of Iowa's multidisciplinary and multiuse system of bioterror 
preparedness and response, we will be prepared and able to 
respond in any biological crisis effectively and efficiently. 
Therefore, additional funding for the smallpox vaccination is 
needed.

                           prepared statement

    Thank you again for the opportunity to provide testimony on 
this matter of critical national importance. We would be happy 
to answer any questions.
    [The statement follows:]
                 Prepared Statement of Jane Colacecchi
    Mr. Chairman, Members of the Subcommittee, I am Jane Colacecchi, 
Interim Director of the Iowa Department of Public Health and with me is 
Mary Jones, Director for the Division of Epidemiology, EMS, and 
Disaster Operations at the Iowa Department of Public Health. She has 
served in a leadership capacity for organizational oversight and 
operational responsibility for disaster/terrorism activities within the 
context of the state's overall public health system. We are here today 
representing Iowa on the immediate need for funding to develop and 
implement the state's smallpox vaccination program.
    We are honored to appear before the subcommittee today, and 
particularly Senator Harkin, as one of Iowa's Senators and an 
important, longtime advocate for public health. We would like to thank 
Chairman Specter and Senator Byrd for their dedication and commitment 
to securing funding for this important initiative. The Iowa Department 
of Public Health greatly appreciates your leadership.
    We are also honored to provide testimony on one of the most 
critical issues facing our nation: bioterrorism preparedness, 
specifically the Smallpox Vaccination Program. The comments that we 
will provide are from the perspective of a state health department as 
it interacts with federal agencies and with our local public health, 
hospital, and first responder partners.
    In April of 2002 Iowa was awarded $11.5 million from CDC to upgrade 
state and local public health jurisdictions in preparedness for and 
response to bioterrorism, other outbreaks of infectious diseases, and 
other public health threats and emergencies. Additionally, Iowa was 
awarded $1.3 million from HRSA to upgrade hospital, EMS, and other 
health care entities in preparedness for and response to bioterrorism. 
This funding has been critical as we begin building the nation's public 
health and healthcare bioterrorism preparedness program. This funding 
must be maintained to support ongoing bioterrorism system development 
as well as preparedness for other public health emergencies. We would 
like to acknowledge and thank you for the work you have done in 
securing this funding for public health and healthcare.
    Funds from CDC and HRSA have been allocated at the local, regional 
and state levels. Through the use of these funds we have:
  --Established six planning regions for public health and health care 
        with membership from local public health, hospitals, EMS and 
        emergency management. Each region meets monthly and they are 
        actively engaged in development of regional bioterrorism 
        preparedness and response plans.
  --Conducted a series of educational sessions on bioterrorism and have 
        held multiple conference calls with local public health and 
        hospitals regarding smallpox planning.
  --Implemented a statewide plan to request and receive pharmaceuticals 
        and medical supplies from the federal government to distribute 
        on a regional basis to local communities for public use.
  --Implemented a 24/7 emergency notification system for each county 
        health department through a statewide paging system.
  --Disseminated public information materials on bioterrorism and 
        smallpox through a supplement in every newspaper in the state.
    Each of the cooperative agreements outline mandated critical 
capacities, benchmarks, and recipient activities that must be funded 
and completed during the cooperative agreement period. These activities 
all significantly contribute to building a statewide system of public 
health and healthcare infrastructure in preparedness for and response 
to bioterrorism. Thousands of hours have been invested by state and 
local public health, healthcare, and emergency management agencies and 
personnel in development of these activities in order to build an 
efficient, and effective statewide system of public health and 
healthcare bioterrorism services that is fully integrated into Iowa's 
Homeland Security and Emergency Response Plan.
                         background and problem
    Since December 13, 2003 when President Bush announced his policy on 
vaccination for smallpox and receipt of subsequent guidance from CDC, 
Iowa has been diligently developing a voluntary state smallpox 
vaccination plan and operational procedures for public health and 
healthcare smallpox teams. No funding has been allocated for the 
smallpox vaccination program; rather it has been recommended that 
states redirect funds from the CDC Bioterrorism Cooperative Agreement 
to the Smallpox Vaccination Program. As a result, our priority has been 
changed from building a system of multi-threat bioterrorism 
preparedness to preparedness for a single biological agent. Redirecting 
of funds from the CDC Bioterrorism Cooperative Agreement to develop and 
implement state smallpox plans will affect our ability to build a 
system of bioterrorism preparedness and response by not funding certain 
critical capacities, benchmarks and recipient activities.
    Smallpox vaccination planning and implementation is damaging other 
aspects of bioterrorism preparedness, not to mention other public 
health programs such as: prevention and treatment of sexually 
transmitted diseases, childhood immunizations, or flu immunizations. 
Some of these programs may have to be delayed or canceled to meet the 
needs of the smallpox vaccination program.
    The risk of a widespread domestic smallpox attack may be low, and 
the benefits of a vaccination program may be limited if our citizens 
are never exposed to the smallpox virus. However in the event of 
exposure to the virus, the benefits of a vaccination program for our 
citizens may be very high. Therefore Iowa is fully committed to 
participation in the public health component of the national 
bioterrorism preparedness strategy.
    Funding is one of the greatest obstacles facing state success in 
program development and implementation. The pre-event smallpox 
vaccination program is a statewide effort to coordinate and manage 
public health and healthcare smallpox teams, create medical specialty 
referral mechanisms, plan and assure the availability of the vaccine 
and vaccination clinics, and monitor and manage adverse events. 
Appropriations for the smallpox program should build capacity to move 
states into the Phase 2 vaccination program and at the same time build 
local infrastructure for mass vaccination or treatment if the need 
should ever arise. Planning for and responding to terrorism or to any 
other public health threat or emergency requires full resources of all 
local, state, and federal entities.
      smallpox vaccination program implementation cost estimations
    Cost estimations for Iowa's Pre-Event Phase 1 Smallpox Vaccination 
Program are based on information obtained from ``Cost Estimations of 
Vaccinating Adults with Smallpox (Vaccinia) in the U.S.: Stage 1 
Vaccination Program'': prepared by Ismael Ortega-Sanchez and Benjamin 
Schwartz, CDC, National Immunization Program, Epidemiology Surveillance 
Division. Draft Version dated November 6, 2002 and from estimations 
made by the Iowa Department of Public Health.
    Cost estimations were assembled in an attempt to reflect state 
costs to develop and implement the Phase 1 Pre-Event Smallpox Program. 
It is estimated that the cost per vaccinee is $400.00. This includes 
costs associated with:
  --Program.--development, coordination, and management (education, 
        training, adverse event surveillance, data management, 
        reporting, statistical services, public information and 
        education),
  --Pre-Vaccination Screening.--volunteer interviewing (exclude from 
        vaccination those with contraindications, education, collecting 
        demographic data, medical data and screening interviews),
  --Vaccine and Vaccination Clinics.--includes vaccine receipt, 
        distribution, stockpile management, storage, vaccination 
        administration, providing bandage supplies to the volunteers, 
        clinic set-up and operations, staffing, record keeping and 
        security,
  --Vaccinators.--initial vaccinator training and education materials, 
        salary, travel and lodging to staff clinics,
  --Volunteer Vaccinees.--reimburse volunteer salaries for vaccination 
        time and vaccine take-check time,
  --Adverse Events.--both direct and indirect costs of complications of 
        smallpox vaccination for adults.
    Iowa is developing 15 healthcare smallpox teams, 6 regional public 
health smallpox response teams with an estimated total vaccination plan 
of approximately 1,000 public health and health care workers for the 
Phase 1 program for a total cost of $400,000. Vaccination is expected 
to arrive in Iowa by the end of this week. Vaccinator training is 
scheduled for February 3--4, 2003 with clinics to commence at the end 
of February. It should be noted that cost estimates for the program 
will be reduced in subsequent phases since some activities will become 
maintenance only, or not be necessary. Caution must be used when 
considering costs for adverse events, medical care, and liability given 
the ongoing debate of what will and will not be covered by health 
insurance, workers compensation, and protections provided by the 
enactment of the Homeland Security Act.
                                summary
    Public health is a new and vital partner in homeland security and 
national defense for bioterrorism and as such, must build a system of 
preparedness and response that may be integrated into existing state 
and federal emergency response and homeland security plans.
    We must not lose sight of our mission to build a comprehensive 
system of public health and healthcare preparedness for and response to 
bioterrorism, outbreaks of infectious diseases and other public health 
threats and emergencies. It is critical that we sustain the mission of 
building public health and health care infrastructure: personnel, 
systems, response capacity and training for bioterrorism. By sustaining 
the development and implementation of Iowa's multidisciplinary and 
multi-use system of bioterrorism preparedness and response, we will be 
prepared and able to respond in any biological crisis effectively and 
efficiently. Therefore, additional funding for the smallpox vaccination 
program is needed.
    Thank you again for the opportunity to provide testimony on this 
matter of critical national importance. We would be happy to answer 
questions.

    Senator Specter. Thank you very much for your testimony, 
Ms. Colacecchi.
    We will now begin another round of questions, and I would 
like for our earlier two witnesses, Dr. Gerberding and Dr. 
Fauci, to join us. I begin on a focus on the issue of risk, and 
that is obviously very difficult to assess. What is the 
likelihood that someone will attack the United States with 
smallpox?
    Dr. Fauci testified that you cannot quantify--he said that 
it could be weaponized. We know from the experience in the 
Soviet Union. Dr. Bell says that it is difficult to ascertain, 
and this subcommittee will pursue this question beyond the 
confines of the medical experts. We will inquire of the 
intelligence agencies as well to see if we can find out more as 
to what the risk factor is.
    It is instructive that there are a number of hospitals 
around the country who are declining to vaccinate. USA Today 
published on January 20 a survey for which they purport to have 
contacted by telephone the public health officials in all 50 
States, and they came to the conclusion that the dissenters are 
a tiny fraction of the 3,000 hospitals recruited by State 
health officials to vaccinate doctors, but there are some more 
than 80 hospitals from every region in the United States, 
including leading teaching hospitals and large urban public 
hospitals, which are forgoing the vaccinations.
    There is an interesting commentary by doctors at the 
Medical College of Virginia Hospitals, where they say that 
instead of having a vaccination program, they would like to 
have 4,000 vaccines locked up in a refrigerator so that they 
could then vaccinate the staff where a problem arose, because 
the vaccine can be taken up to 4 days after exposure and still 
be effective.
    Dr. Fauci, let me start with you. Do you agree that the 
vaccine can be taken up to 4 days after exposure and still be 
effective?
    Dr. Fauci. There are data from a number of studies, 
including one from Bangladesh many years ago, that if you 
vaccinate someone following exposure, there is a window of 
about 3 to 4 days in which, if you can get them vaccinated, 
there is a high probability that you could prevent them from 
getting infected. You could extend that out a little bit more 
if you think in terms of muting the extent of the infection, or 
the complications subsequent to the infection, and so there are 
data from a number of studies suggesting that, in fact, you do 
have a window of approximately 3 or so days.
    Senator Specter. Dr. Gerberding, when there are going to be 
vaccinations, you have a fairly substantial group which will be 
vaccinated, and then you can have some better idea as to what 
the risk factors are when you talk about one to two people out 
of a million dying and 14 to 52 with life-threatening 
reactions, and 1,000 per million with serious reactions such as 
rash, will the people who are accepting voluntary inoculations 
provide a significant base to make an evaluation as to whether 
those risk estimates are accurate?
    Dr. Gerberding. I think we have a long history of using 
this exact same vaccine product and the same protocol, and we 
have the old data. Our concern is, the old data does not 
necessarily apply to the conditions of our current population, 
so we do need to monitor as we go forward, and we will have 
more accurate information as the program evolves.
    Senator Specter. How many people are going to be vaccinated 
under the current plans?
    Dr. Gerberding. The States have requested vaccination for 
about 450,000 people during this first phase. The number in the 
second phase, where we expand to include the people at 
occupational risk in the police, fire department and other 
health care workers, could be up to 10 million, although we do 
not think that immunizing all 10 million is likely.
    Senator Specter. Well, certainly it is not a desirable 
situation to be one of those who is vaccinated with these 
risks, and to use them as a basis for making a further 
determination, but if you vaccinate people into the millions, 
you will have a better evidentiary base to assess risk, will 
you not?
    Dr. Gerberding. We will have more data as we go forward, 
and that is why it is so important that we collect this 
information as we go, and we are also learning from the 
military, because there is a military immunization program.
    Senator Specter. And how many are likely to be vaccinated 
in the military?
    Dr. Gerberding. I do not have the figures. Part of the 
information is not publicly disclosed at this time because it 
has to do with force readiness, but they are anticipating 
immunizing many thousands of people.
    Senator Specter. Well, the uncomplimentary phrase comes to 
my mind of being guinea pigs here, really, which we do not want 
to subject anybody to, but if it is accepted on a voluntary 
basis--of course, the military is not voluntary, but we may 
have a better evidentiary base to shed some light on what Dr. 
Bell is concerned about.
    This is obviously going to be an ongoing matter, but we 
lack any real, quantifiable assessment of risk of attack here, 
and there are comments about North Korea and Iraq likely having 
the smallpox virus, and then we have to quantify it and 
evaluate it in terms of all this other long list, so it is 
going to require a lot of analysis, thought and further study.
    Senator Harkin.
    Senator Harkin. Thank you, Mr. Chairman. I think, Mr. 
Chairman, you have raised the basic issue that I think we 
really have to get at here. You said the issue of risk, and I 
think we need to have some clearheaded thinking on this, and we 
need the best information we can have from the experts, Dr. 
Fauci, Dr. Gerberding, about the experience.
    It is not as though we have never experienced smallpox 
before, but we have a wealth of experience about smallpox, how 
it is transmitted, what the effects are. We also know from past 
experiences how it can be contained, so I think we have to 
begin to think about this in terms of what the real threat is.
    Ms. Colacecchi, I think, in her testimony, and I underline 
this, because I think, again, she is talking about this in 
terms of: ``Are we going in the direction that is going to 
siphon off a lot of money for one threat, as opposed to 
building a system that will protect our people against 
multithreats in this country.'' As a result, to quote Ms. 
Colacecchi: ``our priority has been changed from building a 
system, a multithreat bioterrorism preparedness, to 
preparedness for a single biological agent.''
    So again, what is this threat? For example, I read in one 
of the magazines, Newsweek, Time, I do not know what it was, 
about how Saddam Hussein, if he has this smallpox, what he 
would do is, he would find a willing martyr, inoculate that 
person with the smallpox virus, put that person on an airline, 
the airline flies to the United States, it has got 200 or 300 
people on board, they all disembark in New York, and they go to 
this place and that place and this place, all carrying the 
smallpox virus. A very scary scenario.
    How real is that, Dr. Fauci? How is the smallpox virus 
transmitted? If you have it, can you transmit it from you to me 
right here?
    Dr. Fauci. I would not be able to transmit it from me to 
you where we are staying. It usually occurs, with some 
exceptions--in all of biology, there is a bell-shaped curve, 
there is what usually happens and then there are exceptions. 
There are exceptions if you have very close contact and you do 
not get infected, and there are exceptions if you do not have 
extremely close contact and you do, but for the most part, it 
is accepted through close personal contact, usually within 
family members, or people who spend a lot of time in close 
quarters together.
    That could be in a hospital setting from a health worker 
who is taking care of a patient who comes in either with 
recognized smallpox or unrecognized smallpox, or if someone is 
infected and they go home and there is the close household 
setting. That is the usual way that smallpox is transmitted.
    Senator Harkin. I think we need to get to this, because not 
too long ago, not too many years ago, 15 years ago, where we 
got in all kinds of scary scenarios on how HIV was transmitted, 
until finally the medical experts said ``No, there are certain 
ways, and then, beyond that, you cannot transmit it and contact 
HIV virus.''
    Dr. Fauci. Just to make one other point, that is the way 
that naturally occurring smallpox is transmitted. What that 
does not take into account is an unknown--and getting back to 
the statement that I made before, I cannot or we cannot 
quantitate that risk, but in a situation in which, for example, 
a material might be spread in an aerosolized way, that breaks 
the paradigms of someone just getting it and going into the 
home and having the very close personal contact within a 
family.
    Again, I do not know the likelihood of that, but the 
information that we have on how we disseminate smallpox is 
based on the natural evolution of a naturally occurring 
epidemic, and you just need to take that into consideration. I 
do not know what weight you want to give to it, but you at 
least need to consider it.
    Senator Harkin. I agree we need to consider it, but we need 
to consider it, again, in the framework of what data and what 
facts we know about viruses or about smallpox virus in 
particular here. I have heard about the aerosolization of 
smallpox virus, but how long would the smallpox virus live in 
the atmosphere?
    Dr. Fauci. Quantitatively, significantly less than, for 
example, anthrax spores, but certainly not just seconds. When 
the Soviets were making their weaponized form of smallpox, it 
was for the purpose of putting it in bomblets to be used 
through missiles. Again, this is something that we know 
happened. Whether it is applicable today, given our current 
situation, we cannot quantitate that, but even if you have the 
virus that does not last long in the sunlight, which would 
certainly weaken if not kill it within a reasonable period of 
time, the aerosolized component is something that we do not 
have experience with.
    You very appropriately, Senator, made the point that we 
know a lot about smallpox. We know a lot about naturally 
occurring smallpox. We do not know anything about weaponized, 
deliberate bioterrorist smallpox.
    Senator Harkin. Do we know anything at all, from your data, 
about the virus itself and whether it--can it be, has it been 
modified? Has it been changed? We do not know that, do we?
    Dr. Fauci. That is a possibility, but we do not have any 
definitive evidence that there has been genetically mutated 
smallpox. We have no data on that.
    Senator Harkin. And no information that I am aware of that 
we have on that. So again, I come back to making sure that we 
have adequate data, or at least information available on 
smallpox, on the virus, how it is transmitted, and the threat 
assessment.
    Now, correct me if I am wrong, but it just seems to me that 
if there is any kind of an outbreak of smallpox, that CDC has 
developed over time procedures to be followed for building 
these rings of protection around any kind of an outbreak, so 
again, if we are prepared, and we have that in place, that 
would answer not just smallpox, but other possible viral 
outbreaks, or anthrax, or whatever it might be, that might be 
used as a weapon, but if we are just zeroing in only on 
smallpox, are we taking a threat that might be very small, 
spending a lot of money getting everybody very upset and 
excited about this, and perhaps causing some unknown, 
unanticipated illnesses and deaths, rather than building the 
system that will truly protect the American people not just 
against smallpox, but against all other kinds of threats that 
might come along?
    Dr. Gerberding. Senator, we appreciate so much your 
perspective on this. This is basically the whole premise of the 
CDC's terrorism preparedness program, that we need to build a 
foundation of capacity to deal with all threats, but having 
said that, the investments we are making in this capacity to 
immunize responders for smallpox, and then getting them into a 
shape where we could immunize the entire population, is a 
capacity that will serve us well for whatever countermeasure we 
have to deliver, so if we can do this for smallpox, we can 
deliver antibiotics efficiently for anthrax, we could deliver 
botulism toxin efficiently if we have a botulism exposure, so 
it is not totally unrelated to the principle that you are 
articulating.
    If I could just make a quick statement here to give you 
some idea about how this works, when we get a call that says 
there is a highly suspect case of smallpox, or something that 
could be smallpox, two things happen immediately. One is, we 
get the clinicians in that place to get the sample to the 
nearest laboratory that our appropriation from this committee 
helped support, and get that example to CDC so we can very 
quickly know for sure if it is or it is not, and we can do that 
in about 12 hours.
    Simultaneously with that, we send our smallpox advance 
teams on a plane that we can charter if necessary, even if the 
air space is closed, carrying one of these kits, which carries 
enough vaccine to immunize 1,500 people, and our response teams 
would take this right to that ring of the contacts, and do 
everything possible to prevent the spread from that circle of 
the initial case and the contacts therein, so that helps us.
    Once we have an exposure, we know what to do to contain 
spread, but we also believe that once we have a single case of 
smallpox, the expectation in all communities will be, now the 
threat is no longer questionable, it has happened, and so 
everyone will need immunization, and we need to be able to be 
prepared to respond to that as well.
    Senator Harkin. Thank you very much, Dr. Gerberding.
    Mr. Libbey. Senator, if I might, from the point of the 
actual implementation I would agree with Dr. Gerberding to the 
extent that preparing for smallpox in some areas, particularly 
the phase that we described as community preparation, ties us 
into the issue managing the stockpile for other issues and the 
like, but the level of resources specific to the vaccination 
itself, and to the necessary follow-up care, have limited 
application to other forms of preparedness.
    Senator Specter. Thank you very much, Senator Harkin.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman, and 
thank you, really, to all of our witnesses today. I think that 
all of us are hearing a lot of concerns from our communities 
about what their responsibility is going to be and how they are 
going to pay for this, weighed against the risks that clearly 
have been outlined, but how real they are, and Mr. Libbey, I am 
glad you responded, because I did want to ask you, Dr. 
Gerberding is speaking from a national perspective and putting 
a model together, and certainly in the case of where smallpox 
actually occurred, I think we all know that is different from 
what we are looking at right now, which is prevention, and you 
responded shortly to that, but I would like to ask you 
specifically, do you see that model being in place?
    You talked in your testimony about diverting from other 
resources and other public health care crises. Does this model 
help you, or does it take it away from other things that public 
health officials are trying to do?
    Mr. Libbey. It has helped in some regards in terms of the 
public health community making better and stronger connections 
with the medical care community, other parts of the emergency 
management systems of their community. In that regard, it has 
been helpful, but that would be the case of overall 
bioterrorism preparedness.
    What we have heard in a survey of about 715 respondents, 
two-thirds said it has detracted from their ability to provide 
other public health services, as well as from other 
bioterrorism more broadly, that general preparedness.
    Senator Murray. Because of a singular focus on one issue?
    Mr. Libbey. Because of the singular focus to the issue. 
There will likely be, I would not disagree, some residual level 
of value to preparedness, but to suggest that it is an 
equivalent transfer suitable for other agents or other issues, 
we would question.
    Senator Murray. You in your testimony said that in 
metropolitan areas it would cost between $142 and $222 a person 
to inoculate. I was actually out in Mason County, which is not 
far from where used to be--a very small rural community who 
were very concerned about the costs. Rural communities, would 
the price be higher, because you do not have as many people?
    Mr. Libbey. I think the difference expressed by Iowa is a 
very good example of that, the time travel, the distance, and 
the fewer numbers.
    Ms. Colacecchi. We have larger per capita numbers because 
we have taken a rather conservative approach in the number of 
people that we are inoculating, but we do have increased costs 
due to the rural nature of our State in terms of travel, and 
the ability to train people on a Statewide basis.
    Senator Murray. I think that is what we are hearing from a 
lot of our communities, is how, with all the other burdens they 
are in right now, they are going to pay for this risk, and 
whether the risk is worth it. Certainly, these are difficult 
questions for all of us.
    Dr. Gerberding, I wanted to go back to you again, because I 
listened carefully to Dr. Bell and his testimony in thinking 
through the process at his hospital and deciding not to 
inoculate their health care officials. I know I am hearing from 
several hospitals in my State that have gone through the same 
process and come to the same conclusion, not children's 
hospitals, other hospitals, because patients in hospitals today 
are much sicker than they were 30 or 40 years ago, and could 
possibly be at much higher risk, and weighing those risks is a 
very difficult decision for any hospital administrator.
    How do you respond to Dr. Bell or to the hospitals in my 
State and argue to them a case that is a different conclusion 
than they have come to?
    Dr. Gerberding. I am very respectful of the perspective of 
the panel, in fact of all the panelists. I think we are all 
struggling to find the right balance here between risk and 
preparedness and expediency and, as I said in my testimony, the 
safety of the individuals and the patients involved, and this 
really has to be the highest imperative for us.
    When we put together this implementation plan, we were very 
cognizant of what our goal was. Our goal was to ensure that we 
had sufficient preparedness capacity so that, should we have a 
smallpox attack, we would have the initial infrastructure and 
personnel to be able to mount a much broader population 
campaign. That does not require every hospital to participate. 
It requires that, in a jurisdiction, there are sufficient 
resources in the health care delivery system to take care of 
the initial cases of smallpox.
    So we knew that not every hospital would choose to 
participate. We anticipated that in our calculations, and I am 
very respectful of the decision of individual hospitals, but 
having said that, I must also say that we are concerned about 
spread to patients when we are immunizing health care 
personnel, and we have gotten expert input from two advisory 
committees, our Advisory Committee on Immunization Practices, 
as well as our Specialist in Hospital Infection Control, to 
help us identify what are the hazards to patients and what we 
need to do to protect them.
    So we have a number of steps that would be required in a 
facility to ensure that patients are safe, and that includes 
the hygiene, the covering of the wound, and a daily check of 
each immunized health care worker to make sure that their 
inoculation site is not spreading and that it is properly 
covered, and that the hazard to patients is minimized.
    Senator Murray. And are you concerned that in many 
communities, they do not have the resources, so given this 
concern now, they are diverting resources from other public 
health issues they may have?
    Dr. Gerberding. I really look forward to working with 
NACCHO and other organizations that are assessing that. We 
received progress reports from the jurisdictions in November to 
assess where they were in terms of their implementation of the 
expectations from the appropriation that went out in June. Our 
feedback from that progress report was that people had taken 
excellent steps toward achieving the expected capacities, but 
if there has been a change in that, we will need to get it 
again as we go out for the next round of evaluation, and so we 
will take that concern very seriously.
    Senator Murray. I know my time is running out, but Dr. 
Fauci, I wanted to ask you one other question. We know there 
are risks to children and pregnant women. What research is 
taking place at the institutes that will help us better 
evaluate the long-term impacts on early childhood development, 
or pregnant women, or fetal development? Is there any research 
going on, and what do we know today?
    Dr. Fauci. To my knowledge, no. I would have to get back to 
you on that. That would be through the National Institute of 
Child Health and Development, so that would not be in our 
institute, but I can get that back to you, Senator Murray.
    Senator Murray. Okay. I would really like to know that. 
Thank you.
    Thank you, Mr. Chairman.
    Senator Specter. Thank you very much, Senator Murray.
    On the issue of containment, as opposed to prevention, 
Senator Santorum and I were at Carnegie Mellon recently, and 
the University of Pittsburgh Medical Center, where they are 
collaborating on software to identify people who have signs 
which might be some bioterrorist attack, and they collate 
material from hospitals and from doctors and other medical 
centers in a context of putting all the pieces together to try 
to determine if we are in the incipient beginning stage of a 
bioterrorist attack.
    Now, if we have 4 days--Dr. Fauci, you were not definitive 
on that. You told me about the Bangladesh data, but you did not 
tell me what Dr. Fauci thought about it, but if we really have 
4 days--do we have 4 days, Dr. Fauci, in your judgment?
    Dr. Fauci. I would only have to look at the data, because 
we do not have experience. The last case of smallpox that 
occurred in the United States, I was 9 years old, so I do not 
have experience in that regard, but with regard to the 
information in the literature, I would say that that is a 
strong suggestion that, indeed, you do have a 3- to 4-day 
window.
    Senator Specter. Well, how far along are we on detection? 
The New York Times had a front page story a few days ago about 
eight centers being designated in the United States to collate 
the material to try to predict at a very early stage whether we 
are being subjected to an anthrax attack, or to a smallpox 
attack.
    How good are we at that, and how good could we become, and 
if we could really catch it at the outset, and had 4 days, and 
had the suggestion made by the Richmond medical facility to 
have vaccines in the refrigerator, then we do not have to 
vaccinate all these people and take all these risks if we could 
really contain it with that time interval.
    What do you think Dr. Gerberding?
    Dr. Gerberding. We want to be able to detect this virus at 
its release, if it is an aerosol release. We are not there yet. 
Even with the detection systems that have been deployed, we 
cannot guarantee that we would be able to detect it.
    Senator Specter. We are not there yet. When you say yet, 
are there prospects for getting there?
    Dr. Gerberding. I think the technology is rapidly evolving. 
Some of the research NIH and others are doing will get us 
there.
    Senator Specter. Is the NIH doing the research?
    Dr. Gerberding. The NIH is doing some research.
    Senator Specter. Well, they have lots of money. Dr. Fauci 
has lots of money.
    We have loaded them up with money, $12 billion to $27 
billion. On what date will we have the answer? On what date 
next month will we have the answer to that, Dr. Fauci?
    Dr. Fauci. You know, Mr. Chairman----
    Senator Specter. Do you want a good appropriation this year 
again?
    Dr. Fauci. I am going to give you the right answer for that 
appropriation, Mr. Chairman. We have fundamentally not 
environmental sensor-type research, but we have research to 
detect in the very, very early stage if someone is exposed.
    For example, you can do molecular diagnostics where, prior 
to the virus being in a form where it could be culturable, when 
someone comes in with a suspected case, you would send a 
specimen down to the CDC for identification.
    What we are striving for in the research that is going on 
at the NIH is to develop molecular techniques that can actually 
detect either the genetic material of the smallpox prior to the 
point where it is obvious that it has turned into a disease, in 
other words, post-exposure, but prior to the symptomatology 
stage.
    Senator Specter. How practical is it to follow the 
recommendation of the Richmond medical unit to have 4,000 
vaccines in a refrigerator to be able to spring into action? 
Can that be disseminated and dispersed around the country, so 
that we are in a position to respond within 4 days?
    Dr. Gerberding. The most important part of detection for 
this problem is the astute clinician who recognizes the first 
patient. If they miss the first patient, we will miss the 4-day 
window.
    Senator Specter. Well, how good is our dissemination of 
information? We really ought to be able to educate the 
clinicians on this, should we not?
    Dr. Gerberding. We are doing everything we can. That is 
part of the 3\1/2\ million kits that we are sending out to all 
clinics this month.
    Senator Specter. These are clinicians who went to medical 
school. Did the medical school teach them?
    Dr. Gerberding. That is right, but, you know, they did not 
see a case. I do not think there was much emphasis on any of 
these agents when we were in school, because they are such rare 
diseases.
    Senator Specter. Are the medical schools responding now?
    Dr. Gerberding. Yes, they are.
    Senator Specter. They are now teaching it?
    Dr. Gerberding. Yes, they are.
    Senator Specter. And the medical publications are carrying 
information to educate those who might not know it?
    Dr. Gerberding. The major medical journals have all carried 
articles. For example, the Journal of the American Medical 
Association, which is probably the most widely read journal, 
has had information for clinicians on every one of the select 
agents.
    Senator Specter. Well, in the event that any clinician is 
now watching C-SPAN, Dr. Gerberding, tell them what to look 
for. This is a great educational tool.
    Dr. Gerberding. You are absolutely right. Any patient who 
presents with fever and a rash, particularly a rash that has 
evolved over several days in the context of someone who is 
quite ill and has the characteristic appearance of the----
    Senator Specter. Symptoms?
    Dr. Gerberding. Symptoms of smallpox include high fevers, 
muscle aches, head aches, and, in general, one of the reasons 
why we can contain it after a case has developed is because the 
people who have it are so sick that they are not out in the 
community spreading it, they are home in bed, sometimes 
infecting their contacts.
    Senator Specter. What should the clinician do after 
observing such symptoms?
    Dr. Gerberding. If there is a suspicion, the immediate step 
is to isolate the patient from others in the health environment 
so there is no spread in the emergency room or the clinic. The 
second thing is to call the----
    Senator Specter. And what kind of facility should hospitals 
have for isolating? I said that 2 days ago Senator Santorum and 
I were at UPMC, University of Pittsburgh Medical Center, and 
they had a decontamination room, if the next step is isolation, 
give a little description to the hospitals as to what they 
ought to be doing to prepare for that.
    Dr. Gerberding. Well, as Dr. Fauci said, this virus is 
primarily spread by close contact. We call that droplet 
transmission, occasionally through the air, but most of the 
transmission is through close contact, so simply taking the 
person and putting them in a separate room, and preferably a 
room that has the same kind of air circulation that we use for 
tuberculosis patients, and which most facilities have now, 
because they had to do it as TB came back in, so that you 
isolate them from spreading the virus through their skin to 
other patients, and also through the air.
    Senator Specter. Is there any real risk from moving the 
patient from the time the clinician spots the symptoms to some 
room on the sixth floor, or some distant part of the hospital?
    Dr. Gerberding. Well, we would like to be able to get 
patients to that kind of area with the minimum amount of direct 
contact with other health care workers and other patients.
    Senator Specter. So you would recommend that this room be 
close to the emergency entry?
    Dr. Gerberding. That would be ideal.
    Senator Specter. What other tips do you have for the 
hospital?
    Dr. Gerberding. I think the hospitals really need to think 
about how they will get all of the people in the front line of 
the delivery system alert to this, because the infectious 
disease doctors and the skin doctors are aware of it, but not 
all of the primary care doctors, not all of the residents and 
interns, so there has to be a comprehensive commitment and 
education of all the clinicians who are doing triage.
    Senator Specter. So the hospitals ought to disseminate this 
information.
    Dr. Gerberding. The hospitals need to do it, and CDC and 
HHS are working very hard to make sure they do have the tools.
    Senator Specter. Does CDC have a nice booklet that could be 
distributed to the hospitals to give to all the clinicians?
    Dr. Gerberding. We do. So far, we have distributed 70,000 
copies of something called the fever rash poster, which 
outlines how to diagnose and identify this disease and, as I 
said, this 3\1/2\ million mailing is going out as soon as we 
get all of the addresses of the nurses and the clinicians at 
the local level.
    Senator Specter. 3\1/2\ million?
    Dr. Gerberding. Correct.
    Senator Specter. Is that adequate?
    Dr. Gerberding. Well, it is the biggest step we have ever 
taken to provide direct information in the hands of clinicians, 
but it comes on top of the Internet, the satellite broadcast, 
CD-ROM's, the medical publications, our speaking at medical 
conventions and so on.
    Senator Specter. Is this information on symptoms available 
on the Internet?
    Dr. Gerberding. Absolutely. This is a picture of the poster 
that we have distributed to so many clinicians. This is a 
miniature version of it. This is easily available on our web 
site.
    Senator Specter. So tell anybody who is listening or 
watching C-SPAN what to look for on the Internet.
    Dr. Gerberding. Go to www.cdc.gov, and one of the first 
headings there will link you directly to our smallpox page, and 
we have a special service there that is just for clinicians, so 
they can go into a segment of our web that gives them the 
specialized information that a nurse or a physician or other 
medical provider would need.
    Senator Specter. Dr. Gerberding, we are sort of winging it 
here as to how you inform clinicians, but would you give some 
thought and get back to the committee in a week as to what 
ought to be done in a systematic way?
    Dr. Gerberding. Absolutely.
    Senator Specter. And what you might require by way of 
funding to get it done promptly, and maybe some allocation of 
current resources, with a commitment by the Congress to 
reimburse you so you can go ahead and get this information 
available?
    Dr. Gerberding. Thank you, sir.
    Senator Specter. Mr. Libbey, when smallpox vaccinations 
were administered routinely in the 1950s and 1960s, did the 
public health system carry out the follow-up actions, the 
extensive follow-up that you say is now necessary, and what has 
changed since then that would require the extensive and costly 
follow-up that you have testified about?
    Mr. Libbey. Several conditions, to my knowledge, and I may 
have been even younger then 9 at that point. There was not that 
same level of extensive follow-up, a couple of reasons 
different. The issue of risk and threat was different, because 
the disease was present. I suspect if the disease were present 
now, we would have less involved processes both in the 
vaccination and potentially in the follow-up. We do know and 
anticipate that there will be adverse reactions.
    We also know, absent 30 years of providing this 
vaccination, people are going to see the reaction and not 
understand that it is within, may well be within what is 
normally to be expected, there will be inquiry that will demand 
time and attention, and that there will be adverse reactions 
that need to be screened.
    I would also suggest that one of the changes in the last 30 
years in some ways is a change, as was mentioned earlier, the 
potential vulnerability of the population, but I would also 
suggest the nature, the litigious nature of our society has 
changed somewhat, that makes having these pieces in place.
    I would also point to, these are requirements of the 
program guidelines provided to us for clinical operation of the 
program from our Federal partners.
    Senator Specter. Dr. Gerberding, you wanted to show your 
vaccination.
    Dr. Gerberding. Yes. I just wanted to make sure that the 
committee was aware of what the needles look like and what the 
vaccine would come like. I mentioned the Vaccipack that would 
be taken out. If we had to vaccinate the population, we have 
already kitted and ready to go the smallpox vaccine for 150,000 
doses per kit that our national pharmaceutical stockpile would 
deliver, and what a kit looks like is basically this.
    There is a small vial of vaccine that we would add a 
diluent to using this needle, and then the vaccine needles that 
we are using right now, we are distributing to you and the 
other members of the committee, which is a little needle that 
looks like a miniature salad fork or cocktail fork that would 
be poked into the arm 3 to 15 times to administer the 
inoculation, and I think one of the achievements of the 
appropriation that we have received this year is that our 
national pharmaceutical stockpile can do this efficiently and 
effectively, and we can simultaneously deliver this vaccine to 
every major jurisdiction in the country within 24 hours, just 
like Federal Express.
    We can get this out from the stockpile repositories to the 
front end very, very quickly. That is an enormous step forward 
in our capacity, and we absolutely would not have been able to 
do that without the support from this committee, both because 
we now have enough vaccine to immunize everybody, so we have 
the supply, but we also have this logistical system to get it 
to people if we need it, so our preparedness has improved, and 
we really thank you so much for that investment.
    Senator Specter. Well, we are pleased to hear that the 
funding the subcommittee has initiated has been so fruitful.
    Well, we thank all of you for coming today. I think this 
has been a very, very productive hearing in terms of 
identifying very, very key factors, and perhaps in educating 
people as to what we need to do, but a great deal more needs to 
be done, and this subcommittee intends to pursue the question 
of risk.
    Dr. Fauci, just one more question to you. Do you have any 
indication as to which countries have smallpox potential for 
bioterrorism attacks?
    Dr. Fauci. No, I do not, Mr. Chairman. The only thing I 
have is what I believe you have also, is what we have read in 
the newspapers about various intelligence reports, but I do not 
have information of intelligence that you do not have yourself.
    Senator Specter. Well, what we need to do is to try to make 
the intelligence available to the public, if there is any, and 
we may not be dealing with much to work on. We can pursue the 
line that the Soviet Union had weaponized smallpox. That is an 
important factor.
    This sort of comes under the same category as our effort to 
buy down their nuclear weapons, the so-called Nunn-Lugar buy-
down, where have put in hundreds of millions of dollars, but we 
need to get a better assessment on risk, and we need to have a 
better assessment as to the 4-day interval and move ahead with 
the identification of these symptoms, and to try to educate 
clinicians as to what ought to be done, and then to try to get 
the hospitals to have the isolation rooms like the one I saw on 
Monday to move ahead.
    And I think time is of the essence. We cannot take anything 
for granted. We have had a year-and-a-half, but who knows what 
is going to come next.
    Well, we will all pursue the matter together.

                         CONCLUSION OF HEARING

    Thank you all very much for being here, that concludes our 
hearing.
    [Whereupon, at 11:40 a.m., Wednesday, January 29, the 
hearing was concluded, and the subcommittee was recessed, to 
reconvene subject to the call of the Chair.]

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