[Senate Hearing 108-221]
[From the U.S. Government Publishing Office]
S. Hrg. 108-221
IMPLEMENTATION OF SMALLPOX VACCINATION PLAN
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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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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
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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
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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
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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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