Smallpox Vaccination: Implementation of National Program Faces	 
Challenges (30-APR-03, GAO-03-578).				 
                                                                 
Amid growing concerns about a potential smallpox attack, the	 
Centers for Disease Control and Prevention (CDC) is working with 
62 state, local, and territorial jurisdictions to implement the  
civilian part of the National Smallpox Vaccination Program. The  
goal is to increase the nation's response capacity by vaccinating
health workers for Smallpox Response Teams as quickly as is	 
safely possible. A civilian program using vaccination to bolster 
bioterrorism preparedness is unprecedented, the health risks are 
uncertain, and the public health system has had little recent	 
experience with smallpox. Safe implementation of such a program  
will be complex. GAO was asked to examine implementation and its 
challenges. GAO reviewed program materials and data and 	 
interviewed CDC officials and representatives of organizations	 
involved.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-03-578 					        
    ACCNO:   A06765						        
  TITLE:     Smallpox Vaccination: Implementation of National Program 
Faces Challenges						 
     DATE:   04/30/2003 
  SUBJECT:   Chemical and biological agents			 
	     Counterterrorism					 
	     Health care programs				 
	     Immunization programs				 
	     Infectious diseases				 
	     Internal controls					 
	     National preparedness				 
	     Program management 				 
	     Strategic planning 				 
	     National Smallpox Vaccination Program		 

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GAO-03-578

Report to the Chairman, Committee on Governmental Affairs, U. S. Senate

United States General Accounting Office

GAO

April 2003 SMALLPOX VACCINATION

Implementation of National Program Faces Challenges

GAO- 03- 578

Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. Vaccinations are to be given to volunteers in two
stages. CDC*s nationwide target for the first stage was an estimated
500,000 health workers in 30 days. The number of health workers was based
on the jurisdictions* combined targets for their Smallpox Response Teams.
In the second stage, CDC plans to expand the program to as many as 10
million additional health workers and other emergency response personnel.
On the official start date of vaccination, January 24, 2003, only one
state began vaccinating. CDC reports that by week 10 (April 4, 2003) about
6 percent of the number of volunteers targeted for the first stage had
been vaccinated. Eight states accounted for about half of the vaccinees.
Because of the slow

pace, not enough data were generated by week 10 to evaluate whether the
program is proceeding as safely as possible.

Implementation of the program is facing two major challenges. The first is
the program schedule, which placed heavy demands on CDC and the
jurisdictions. The second is hesitation on the part of the two main groups
needed to participate in the program* the state and local public health
authorities and hospitals needed to implement it, and the health workers
needed to volunteer to be vaccinated. Many implementers are concerned
about insufficient resources to support the program and about liability
protection. Many potential volunteers are concerned about health risks to
themselves and their co- workers, families, and patients and about
compensation for adverse events and lost income. Program officials and
Congress have been working to address some of the

major challenges but it is too soon to evaluate the impact of these
efforts on participation in the program. Unless these efforts succeed in
overcoming the hesitancy of the participants, it may be difficult to
achieve the initial targets for the first stage. CDC has reconsidered the
initial targets and said that as few as 50, 000 vaccinated health workers
nationwide would provide

sufficient response capacity. But as of late April, CDC had not set a new
nationwide target or requested that the 62 jurisdictions adjust their
targets for numbers and types of vaccinated health workers and
distribution of response teams. CDC also has not said what the
implications of this potential change in targets for the first stage would
be for the second stage. In addition, although CDC announced that it would
provide guidance for and request plans from the jurisdictions for the
second stage, it has not yet done so. Amid growing concerns about a

potential smallpox attack, the Centers for Disease Control and Prevention
(CDC) is working with

62 state, local, and territorial jurisdictions to implement the civilian
part of the National Smallpox Vaccination Program. The goal is to increase
the nation*s response capacity by vaccinating health workers for Smallpox

Response Teams as quickly as is safely possible. A civilian program using
vaccination to bolster bioterrorism preparedness is unprecedented, the
health risks are uncertain, and the public health system has had little
recent experience with smallpox. Safe implementation of such a program
will be complex. GAO was asked to examine implementation and its
challenges. GAO reviewed program

materials and data and interviewed CDC officials and representatives of
organizations involved.

GAO recommends that the Director of CDC provide guidance to the
jurisdictions for

 estimating response capacity needs and revising targets for the first
stage and  implementing the second stage, that is, vaccination of
additional health workers and other emergency response

personnel. CDC concurred with these recommendations.

www. gao. gov/ cgi- bin/ getrpt? GAO- 03- 578. To view the full report,
including the scope and methodology, click on the link above. For more
information, contact Marcia Crosse at (202) 512- 7119. Highlights of GAO-
03- 578, a report to the

Chairman of the Committee on Governmental Affairs, U. S. Senate

April 2003

SMALLPOX VACCINATION

Implementation of National Program Faces Challenges

Page i GAO- 03- 578 National Smallpox Vaccination Program Letter 1 Results
in Brief 4 Background 6 Implementation Is Slower Than CDC Planned 11 Major
Challenges Are Program Schedule and Hesitancy on Part of

the Two Main Groups Involved in Program 14 Major Challenges Have Not Been
Overcome and Continue to Affect Implementation 22 Conclusions 24
Recommendations 25 Agency Comments 25 Appendix I Comments from the Centers
for Disease Control

and Prevention 27

Appendix II GAO Contact and Staff Acknowledgments 29 GAO Contact 29
Acknowledgments 29 Related GAO Products 30

Tables

Table 1: Targets for the First Stage of the Program, as Initially Proposed
by the 54 Jurisdictions with CDC- Approved Plans 8 Table 2: Status of
National Smallpox Vaccination Program

Implementation, Day 1 through Week 10 12 Table 3: Key Events in National
Smallpox Vaccination Program Time Line as of April 2003 15 Contents

Page ii GAO- 03- 578 National Smallpox Vaccination Program Abbreviations

ASTHO Association of State and Territorial Health Officials CDC Centers
for Disease Control and Prevention DOD Department of Defense FDA Food and
Drug Administration HHS Department of Health and Human Services HIV human
immunodeficiency virus HRSA Health Resources and Services Administration
IOM Institute of Medicine NACCHO National Association of County and City
Health Officials VIG vaccinia immune globulin WHO World Health
Organization

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its entirety without further permission from GAO. It may contain
copyrighted graphics, images or other materials. Permission from the
copyright holder may be necessary should you wish to reproduce copyrighted
materials separately from GAO*s product.

Page 1 GAO- 03- 578 National Smallpox Vaccination Program

April 30, 2003 The Honorable Susan M. Collins Chairman Committee on
Governmental Affairs United States Senate

Dear Chairman Collins: On January 24, 2003, four physicians in Connecticut
became the first civilians in this country to receive the smallpox
vaccine* which has not been routinely administered in over 30 years* as
part of the administration*s National Smallpox Vaccination Program. The
program, which was announced by the President in December 2002, was
developed in response to growing concern that a terrorist or hostile
regime might have access to the smallpox virus and attempt to use it as an
agent of bioterrorism against the American people. In 1980, after a
successful eradication program, the World Health Organization (WHO)
declared the world free of naturally occurring smallpox. However, concern
remains

that stockpiles of the virus may exist in laboratories other than the two
repositories designated by WHO following eradication. 1 Although the
administration indicated that a terrorist attack involving smallpox is not
imminent, it determined that the program should proceed as quickly as is
safely possible.

The Centers for Disease Control and Prevention (CDC) is charged by the
Department of Health and Human Services (HHS) with implementing the
civilian part of the smallpox vaccination program. 2 The goal of the
program is to increase the nation*s smallpox preparedness capacity by
offering vaccinations safely to volunteer health workers to increase their
readiness to respond to a smallpox attack. 3 CDC planned for the

1 The two designated repositories are at the Centers for Disease Control
and Prevention in Atlanta, Georgia, and at the Russian State Centre for
Research on Virology and Biotechnology in Koltsovo, Russia.

2 The program also includes provision for the mandatory vaccination of
500,000 Department of Defense personnel, primarily those deployed in high-
threat areas, and offers vaccination on a voluntary basis to State
Department personnel deployed in the Middle East.

3 Centers for Disease Control and Prevention, Supplemental Guidance for
Planning and Implementing the National Smallpox Vaccination Program
(Atlanta, Ga.: Nov. 22, 2002).

United States General Accounting Office Washington, DC 20548

Page 2 GAO- 03- 578 National Smallpox Vaccination Program

vaccinations to be carried out in two stages. The first stage began on
January 24, 2003, the date on which protection against liability for
injury or death arising from smallpox vaccine administration became
effective under the Homeland Security Act of 2002 for entities or
individuals involved in implementing the program. 4 CDC planned that
during the first stage the vaccine would be offered on a voluntary basis
to an estimated 500,000 public health and health care workers, who would
be formed into Smallpox Response Teams. 5 These teams would be responsible
for investigating an outbreak following a bioterrorist attack, caring for
patients, and vaccinating members of the public who may have been exposed
to the virus. CDC planned to complete the first stage in 30 days. During
the second stage, the program would be expanded to as many as 10 million
other health care workers, police officers, firefighters, and emergency
medical technicians, again on a voluntary basis. 6 CDC is implementing the
smallpox vaccination program in collaboration

with 62 state, local, and territorial governments. 7 Thus the plan for the
program is embodied in multiple federal guidance documents and
recommendations, the individual CDC- approved plans of the 62

4 Protected entities and individuals include manufacturers and
distributors of certain measures to counter bioterrorism using smallpox;
hospitals, clinics, and other health care entities under whose auspices
such measures are administered; and licensed health care professionals or
other individuals authorized to administer the measures under state law.

The Homeland Security Act of 2002, which was enacted on November 25, 2002,
provides that these entities and individuals are to be treated as federal
employees for purposes of liability arising from the administration of
certain measures to counter smallpox under the

smallpox vaccination program. Therefore the federal government would
become the defendant in claims for injury or death made in this context.
These provisions became effective 60 days after enactment. Homeland
Security Act of 2002, Pub. L. No. 107- 296, S: 304, 116 Stat. 2135, 2165
(2002). 5 We found in CDC files and statements of federal program
officials estimates ranging from about 400,000 to about 700,000 health
workers to be vaccinated in the first stage. These estimates were derived
using various assumptions. We have selected the estimate of 500,000
because it was the one provided to the public in conjunction with the
President*s announcement of the program. 6 Although HHS does not recommend
vaccination for the general public, it recognized that some members of the
public may want to be vaccinated and has stated its intention to work to
accommodate them later in the program.

7 In addition to the 50 states and the District of Columbia, the 62
jurisdictions include the nation*s three largest municipalities, New York
City, Chicago, and Los Angeles County, as well as the commonwealths of
Puerto Rico and the Northern Mariana Islands, American

Samoa, Guam, the U. S. Virgin Islands, the republics of Palau and the
Marshall Islands, and the Federated States of Micronesia.

Page 3 GAO- 03- 578 National Smallpox Vaccination Program

jurisdictions, and the plans of thousands of individual hospitals
involved. Each of the jurisdictions and hospitals has tailored its first-
stage planning and targets for numbers and distribution of teams and
numbers and types of health workers on the teams to its own particular
circumstances. CDC has defined the program*s targets for national
preparedness as the sum of the targets set by the jurisdictions in their
plans.

A large- scale public vaccination program against a disease that no longer
exists as a natural threat is unprecedented and presents many challenges.
The relatively small and known risks of adverse events associated with
vaccines in past vaccination programs have been justified on the basis of
the need to reduce a known incidence of disease in the population. For

smallpox, such justification no longer exists. Both the nature and rates
of adverse events to be expected in today*s population 8 and the risk of a
bioterrorist attack are uncertain, making the development and safe
implementation of a program of smallpox vaccination especially
challenging.

In recognition of the potential difficulties in implementation of the
smallpox vaccination program, you requested that we determine (1) how
implementation of the civilian part of the program is proceeding, (2) what
challenges have been encountered, and (3) whether these challenges have
been addressed.

In carrying out our work, we conducted a literature review and examined
program- related materials and data and interviewed officials and
representatives involved in the program. Specifically, we obtained
program- related materials and data on plans, numbers of health workers
vaccinated, shipments of vaccine, adverse events reported, and other
relevant information from CDC through the first 10 weeks of vaccination.
We obtained data about the jurisdictions from the Association of State and
Territorial Health Officials (ASTHO) and the National Association of

County and City Health Officials (NACCHO). We reviewed relevant materials
from the Department of Defense (DOD), the Institute of Medicine (IOM),
WHO, the 62 jurisdictions, and 25 organizations representing state and
local health authorities, hospitals, physicians,

8 Today*s civilian population has a larger proportion of people with
compromised immune systems due to HIV (human immunodeficiency virus),
cancer treatment, and organ transplantation, as well as higher rates of
some conditions that indicate against smallpox vaccination, such as
eczema, than the 1960s population from which most of the data about
smallpox vaccination come.

Page 4 GAO- 03- 578 National Smallpox Vaccination Program

nurses, and other health workers. In addition, we interviewed
representatives from some of those organizations, including the American
College of Emergency Physicians, the American Hospital Association, the
American Nurses Association, ASTHO, NACCHO, and the Service Employees
International Union, as well as CDC and IOM and selected jurisdictional
public health officials. We did not systematically review the
jurisdictional plans nor survey the jurisdictions, and thus we provide
information about jurisdictions only to illustrate the range of policies
and activities they encompass. We did not independently verify data
provided to us by CDC and organizations involved in the program; however,
we

tested the data and determined that they were adequate for our purposes.
We conducted our work from January 2003 through April 2003 in accordance
with generally accepted government auditing standards.

Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. On the start date of vaccination, most of the 62
jurisdictions were not prepared to begin vaccinating volunteers: More than
half had not yet requested vaccine from CDC, and most of the remaining
jurisdictions had requested that their vaccine not be shipped until after
the start date. On the first day, only one state began vaccinating. As
many jurisdictions had projected in their individual plans, the
vaccination of health workers in the first stage of the program is taking
longer than the 30 days set by CDC as an initial target. CDC reports that
by week 10 about 6

percent of the initial target (a total of 31,297 health workers) had been
vaccinated in 54 of the 62 jurisdictions. Eight states accounted for about
half of the vaccinees. As of week 10, there are not enough data to
precisely estimate rates of adverse events and other indicators of program
safety.

Implementation of the program is facing two major challenges* the program
schedule, which placed heavy demands on CDC and the jurisdictions, and
hesitation on the part of the two main groups needed to participate. CDC
developed extensive guidance, training and educational

programs, and other materials to support implementation, but the schedule
made it difficult for the agency to resolve all issues prior to the start
of vaccination. For example, a CDC data system for hospitals to track
adverse reactions was not available until more than 3 weeks after
vaccinations had begun. The jurisdictions had less than 3 weeks to develop
their plans and less than 2 months to prepare to begin vaccination.
Although generally supportive of the program*s goal, the two major groups
of participants* the state and local public health authorities and
hospitals needed to implement it, and the health workers needed to
volunteer to be vaccinated* have concerns and therefore are hesitating to
participate. Results in Brief

Page 5 GAO- 03- 578 National Smallpox Vaccination Program

Many implementers are concerned about insufficient resources to support
the program and about liability protection. Many potential volunteers are
concerned about safety and protection for themselves and their coworkers,
families, and patients and about compensation for adverse events and lost
income.

CDC and HHS have been working to address the major challenges, but to date
they have not been able to overcome them. With regard to the challenging
program schedule, CDC has reconsidered the initial target of vaccination
of 500,000 public health and health care workers in 30 days. It has said
that there is no longer a deadline for the first stage and that as few

as 50,000 vaccinated health workers nationwide would provide sufficient
capacity to respond to a smallpox attack. But as of late April, CDC had
not set a new nationwide target or requested that the 62 jurisdictions
adjust their targets for numbers and types of vaccinated health workers
needed to effectively investigate an outbreak, care for patients, and
vaccinate members of the public with fewer, smaller, or differently
distributed

Smallpox Response Teams. CDC also has not said what the implications of
this potential change in targets for the first stage would be for the
second stage involving police, fire, and other workers. In addition,
although CDC announced that it would provide guidance for and request
plans from the jurisdictions for the second stage, it has not done so.
Program officials have also worked to address the concerns impeding
participation by the implementers and volunteers, but many of these remain
unresolved. To address the implementers* concern about resources, HHS
announced in late March that up to 20 percent of 2003 bioterrorism
preparedness funding would be available to the jurisdictions immediately
upon approval of their applications by CDC, but HHS has not yet specified
this application procedure. In addition, in mid- April Congress
appropriated other funds to support implementation of the smallpox
vaccination program. To address the volunteers* concern about
compensation, on April 24, 2003, Congress presented legislation to the
President for his signature that provides benefits to public health and
health care team members participating in a smallpox emergency response
plan and public safety personnel who are injured as a result of receiving
the vaccine. It is

too soon to evaluate the impact of these legislative efforts on
participation in the program.

We are making recommendations to the Director of CDC to provide guidance
to the jurisdictions for revising targets for the first stage of the
smallpox vaccination program and for expansion of the program in the
second stage. CDC concurred with our recommendations and provided
information about guidance it is planning to issue.

Page 6 GAO- 03- 578 National Smallpox Vaccination Program

Since the terrorist attacks of September 11, 2001, and the subsequent
anthrax cases, there has been heightened public awareness and fear of
potential bioterrorist attacks, including an attack involving smallpox.
Smallpox is a contagious disease whose symptoms include fever and a
distinctive progressive skin rash. It is fatal in about 30 percent of
cases and is considered by CDC to be one of the six biological agents that
pose the greatest potential threat for adverse public health impact and
have a moderate to high potential for large- scale dissemination. 9 There
is no specific treatment for smallpox, but according to CDC it can be
prevented or its course can be significantly modified in most people
through vaccination within 3 days of exposure, and vaccination 4 to 7 days
after exposure will probably offer some protection or may lessen the
severity of the symptoms. 10 The successful use of mass vaccinations to
control deadly and debilitating

diseases worldwide is one of the great public health achievements of the
past century. Routine immunization programs have been built around safe
and effective vaccines targeted at smallpox, poliomyelitis, measles,

rubella, tetanus, diphtheria, influenza, and other infectious diseases.
Although vaccination programs have provided great benefits, they also
carry some risk. Most vaccines, like most medications, have a very small
rate of severe adverse reactions.

Public vaccination for smallpox began in the United States in the early
1800s, when Massachusetts began to require smallpox vaccinations for its
residents. By the late 1800s, smallpox was coming under control in the
United States as the practice of vaccination became more routine. By the
1960s, experience had shown that for every 1 million people vaccinated for

the first time, between 14 and 52 could experience serious and potentially
life- threatening adverse events and 1 to 2 could die. But these risks
were deemed acceptable to control this contagious and often fatal disease.
By 1972 the risk of smallpox in the United States was sufficiently remote
that routine vaccinations were discontinued, 8 years before WHO*s
announcement that the disease had been eradicated worldwide.

9 The other agents in the group are anthrax, botulism, plague, tularemia,
and viral hemorrhagic fevers. 10 Centers for Disease Control and
Prevention, Smallpox Fact Sheet: Vaccine Overview

(Atlanta, Ga.: Dec. 9, 2002). Background

Role of Vaccination in Public Health

Smallpox Vaccination

Page 7 GAO- 03- 578 National Smallpox Vaccination Program

Immunity to the virus that causes smallpox* the variola virus* is
conferred through inoculation with a vaccine made from the closely related
vaccinia virus. The smallpox vaccine does not contain the variola virus
and cannot cause smallpox. The smallpox vaccine is a *live virus*

vaccine; that is, the vaccinia virus it contains is living and may produce
mild reactions, including rash, fever, and head and body aches. 11 In
certain groups of people, including those with compromised immune systems
and certain skin conditions such as eczema, adverse events associated with
the

vaccine can be severe. Because the virus is live, it can be transmitted to
other parts of the body or to other people, who could also face
potentially serious complications, and so care has to be taken to minimize
the risk of

spreading the vaccinia virus from the vaccination site. 12 Previous
experience with the vaccine has shown that it spreads to other parts of
the vaccinee*s body at a rate of 25 to 532 per million individuals
vaccinated and spreads from the vaccinee to others at a rate of 20 to 60
per million.

The National Smallpox Vaccination Program is unique in the history of
civilian immunization programs in that it is not a public health program
in the traditional sense but rather a program of bioterrorism
preparedness. The population to be vaccinated in the first and second
stages of the civilian part of the program is not the general public as in
traditional programs, but key public health, health care, and emergency
response workers. Smallpox Response Teams vaccinated in the first stage
would receive vaccine not solely to protect their own health but primarily
to increase the nation*s capacity to respond to a smallpox attack by
investigating an outbreak, caring for patients, and vaccinating members of
the public who may have been exposed. Because vaccination soon after
exposure can prevent or reduce the severity of the disease, planners
project that there will be sufficient time for these key workers to
vaccinate members of the public as needed to contain a smallpox outbreak
after it

has been recognized. CDC*s guidance allows the 62 jurisdictions some
flexibility in forming their Smallpox Response Teams. For example, it
provides recommendations for

11 Live virus vaccines, like all other licensed vaccines, are considered
safe and effective for most people with healthy immune systems. Other live
virus vaccines include those for measles, mumps, rubella, and chickenpox.

12 For more information on smallpox and the smallpox vaccine, see CDC*s
smallpox fact sheets at http:// www. cdc. gov/ smallpox. The National
Smallpox

Vaccination Program

Page 8 GAO- 03- 578 National Smallpox Vaccination Program

the types of workers to be included in the two types of Smallpox Response
Teams* the Public Health Smallpox Response Teams and the Healthcare
Smallpox Response Teams* but leaves the numbers of workers and exact
composition of teams to the jurisdictions to decide on the basis of their
particular needs. For the public health teams, which are based at state
and local public health agencies, the guidance states that each team
should have a medical expert as team leader and should include public
health advisors, medical epidemiologists, disease investigators,
laboratory

workers, nurses, and vaccinators. For the health care teams, which are
based at hospitals, the criteria for choosing which health care workers to
include are to be developed locally. Each jurisdiction was to have formed
at least one public health team and as many other public health and health
care teams as it deemed necessary by 30 days from the announced start date
of vaccination. The jurisdictions* plans vary widely in terms of the time
line for the first stage of vaccination and their targets for the numbers
of teams and workers to be vaccinated (see table 1). The jurisdictions
with CDC- approved plans proposed to vaccinate 1,101 public health teams
and 4,532 health care teams, for a total of 415,691 vaccinated volunteers
nationwide. 13 Although CDC had called for the first stage of vaccinations
to be completed in 30 days, many jurisdictions expected vaccinations to
take longer than that to complete.

Table 1: Targets for the First Stage of the Program, as Initially Proposed
by the 54 Jurisdictions with CDC- Approved Plans

Targets Average Minimum Maximum

Planned duration of first stage (in days) 55 7 126 Planned number of
Public Health Smallpox Response Teams 21 1 107 Planned number of
Healthcare Smallpox Response Teams 92 2 375 Planned number of volunteers
to be vaccinated 7,997 323 40,000 Planned number of volunteers to be
vaccinated per million population 1,903 81 8,772

Source: GAO analysis of CDC data. Note: The plans for the territories had
not been approved as of January 2003.

13 The plans for the territories were not yet approved when CDC derived
these figures, which therefore represent the totals from the plans for the
50 states, the District of Columbia, New York City, Chicago, and Los
Angeles County.

Page 9 GAO- 03- 578 National Smallpox Vaccination Program

CDC has said that safety is the top priority in implementing this program.
To enable jurisdictions to implement this program in the safest manner
possible, the agency has provided guidance and materials for critical
elements of the program, including

 education and training of health workers who will be administering the
vaccinations;  education and screening of volunteers to rule out those
who may be at

greater risk for severe reactions;  care of the site of vaccination on
the vaccinee*s body to prevent secondary infection or transmission to
others;

 monitoring of adverse events;  distribution of the two investigational
drugs used in treating certain

adverse reactions caused by the vaccine, vaccinia immune globulin (VIG)
and cidofovir 14 ; and  systems for ongoing collection, management, and
analysis of program

data* including adverse events, 15 transmissions of the vaccinia virus to
individuals the vaccinee was in contact with following the vaccination (or
*secondary transmission*), requests for VIG or cidofovir, needlestick
injuries to vaccinators, 16 and vaccine wastage* to evaluate the program
and make adjustments as necessary.

In addition, CDC is sponsoring an advisory group, the IOM Committee on
Smallpox Vaccination Program Implementation, to provide advice to program
officials at CDC on selected aspects of program implementation, including
guidelines and instruments for screening; measures to ensure the early
recognition, evaluation, and appropriate treatment of adverse events;
plans for collecting and analyzing data; and the achievement of

14 VIG, which is recommended as the first line of therapy, and cidofovir
are available for civilians only through CDC following consultation with
CDC staff. 15 Most of these systems are passive surveillance systems,
which rely on patients or staff

involved in their care to take the initiative to provide data. Adverse
events that require hospitalization or outpatient care (such as
encephalitis, eczema vaccinatum, progressive vaccinia, and inadvertent
inoculation) are being tracked by CDC and state health departments
primarily using the Vaccine Adverse Events Reporting System, which is a
passive system. CDC expects adverse events of this kind to be well
captured by a passive system, but less severe adverse events that do not
require treatment (such as low- grade fever, headache, mild skin rash, and
nausea) to be underreported.

16 Procedures involving needles pose the risk that either the person using
the needle or someone involved in its disposal will be unintentionally
stuck, thereby potentially coming in contact with whatever substance the
needle delivered and the blood of the person on whom it was used.

Page 10 GAO- 03- 578 National Smallpox Vaccination Program overall goals
of the smallpox vaccination program. This committee has issued two of a
planned series of reports.

Originally, the program had no provisions to compensate anyone for lost
time from work, health care costs, disability, or death due to adverse
events. Instead, it was expected that workers would be covered by existing
mechanisms such as workers* compensation and insurance.

The initial federal funding for the smallpox vaccination program came from
CDC*s bioterrorism preparedness funding. Since fiscal year 1999, HHS has
distributed funding for bioterrorism preparedness to state and local
health departments in the 62 jurisdictions primarily through CDC*s
Bioterrorism Preparedness and Response Program. 17 In January 2002, HHS
announced the availability of supplemental funding through the CDC program
and a Health Resources and Services Administration (HRSA) program. Under
the CDC program, $918 million in supplemental funding was made available
to jurisdictions for general bioterrorism preparedness. 18 HHS required
jurisdictions to submit their applications for these funds by April 15,
2002. Each jurisdiction was to develop a plan during 2002 to improve
general bioterrorism preparedness within six

categories: preparedness planning and readiness assessment, surveillance
and epidemiology capacity, laboratory capacity for biological agents,
communications and information technology, risk communication and health
information dissemination, and education and training. At the same

time, under the Bioterrorism Hospital Preparedness Program, HRSA made $125
million available through cooperative agreements to the jurisdictions to
enhance the capacity of hospitals and associated health care entities to
respond to bioterrorist attacks, as well as other public health
emergencies. In March 2002, CDC announced the extension of its
Bioterrorism

Preparedness and Response Program through August 2005, without indicating
whether additional funds would be available. On November 22,

17 U. S. General Accounting Office, Bioterrorism: Federal Research and
Preparedness Activities, GAO- 01- 915 (Washington, D. C.: Sept. 28, 2001).
Also see the *Related GAO Products* section at the end of this report. 18
The funds were appropriated by the Department of Defense and Emergency
Supplemental Appropriations for Recovery from and Response to Terrorist
Attacks on the United States Act, Pub. L. No. 107- 117, 115 Stat. 2230,
2314 (2002), and the Department of Health and

Human Services and Education, and Related Agencies Appropriations Act for
Fiscal Year 2002, Pub. L. No. 107- 116, 115 Stat. 2186, 2198 (2002).
Initial Federal Funding for

the Smallpox Vaccination Program

Page 11 GAO- 03- 578 National Smallpox Vaccination Program 2002, CDC
notified the jurisdictions that they were to plan and implement the
National Smallpox Vaccination Program by utilizing and redirecting

the monies previously disbursed under the Bioterrorism Preparedness and
Response Program. These plans for the first stage of smallpox vaccination
were due to CDC on December 9, 2002.

Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. Because of the slow pace, not enough data have
been generated to determine whether implementation is proceeding as

safely as possible according to the program*s goal. Specifically,
vaccination of health workers in the first stage has proceeded slowly.
CDC*s initial target date for completion of the first stage has passed. As
of the start date for vaccination, January 24, 2003, most of the
jurisdictions were not ready to begin vaccinating: More than half of the
jurisdictions had not yet requested vaccine from CDC, and most of the
remaining jurisdictions had requested that their vaccine not be shipped
until after the start date. (See table 2.) On the first day, four health
care workers in one jurisdiction* Connecticut* were vaccinated. As many
jurisdictions had projected in their individual plans, the vaccination of
health workers in the first stage of the program is taking longer than the
30 days set by CDC as an initial target. By the end of the tenth week,
April 4,

2003, 7 jurisdictions had yet to request vaccine, but the rest had
requested and received their shipments. Although CDC reported that a total
of 31,297 health workers (about 6 percent of the initial target) had been
vaccinated in 54 of the 62 jurisdictions by week 10, about half of those
vaccinated

were distributed across eight states: Florida, Minnesota, Missouri,
Nebraska, North Carolina, Ohio, Tennessee, and Texas. Sixty- two percent
of those vaccinated were Healthcare Smallpox Response Team members, and 33
percent were Public Health Smallpox Response Team members;

the remaining 4 percent were *other,* which includes public officials who
are not part of a Smallpox Response Team. 19 As of late April, CDC did not
have information about the number of complete response teams formed. As of
week 10, CDC reported that roughly one- third of an estimated 5,000 acute
care hospitals in the jurisdictions began vaccinations. Almost half of
these hospitals are in seven jurisdictions: Florida, Louisiana, Missouri,
Nebraska, Ohio, Tennessee, and Texas.

19 Due to rounding, the percents do not total to 100. Implementation Is

Slower Than CDC Planned

Page 12 GAO- 03- 578 National Smallpox Vaccination Program Table 2: Status
of National Smallpox Vaccination Program Implementation, Day 1 through
Week 10

As of day 1 (January 24, 2003)

As of week 4 (February 21, 2003)

As of week 10 (April 4, 2003)

Number (percent) of jurisdictions that had requested vaccine a 27 (44%) 52
(84%) 55 (89%) Number (percent) of jurisdictions that had received vaccine
a 8 (13%) 52 (84%) 55 (89%)

Number (percent) of jurisdictions that had initiated vaccinations a 1 (2%)
40 (65%) 54 (87%) Number (percent) of volunteers vaccinated b 4 (< 1%)
7,354 (< 2%) 31,297 (6%)

Source: CDC. a Percent of total of 62 jurisdictions.

b Percent of initial estimated target of 500,000.

Because progress has been slow, to date there are not enough data to
precisely gauge indicators of the safety of implementation. For example,
too few health care workers have been vaccinated and too little time has
passed since their vaccination to precisely estimate rates of adverse
events. Therefore it cannot yet be determined whether the rates are the
same as would have been anticipated on the basis of historical data or
different enough to trigger reconsideration of how the program should
proceed. As of April 4, 2003, CDC had received reports of 68 moderate to
severe adverse events 20 and 250 less severe adverse events, such as fever
and rash, potentially related to smallpox vaccination. In addition, CDC
had received reports that two volunteers who had been vaccinated died of
heart attack, but CDC has not yet determined whether the deaths were

20 These reports include cases of generalized vaccinia, inadvertent
inoculation, myocarditis, pericarditis, and ocular vaccinia, but no
reports of other severe adverse events, such as progressive vaccinia,
eczema vaccinatum, encephalitis, encephalomyelitis, or vaccinia
transmission.

Page 13 GAO- 03- 578 National Smallpox Vaccination Program related to the
smallpox vaccine. 21 CDC officials maintain that the low number of severe
adverse events associated historically with smallpox

vaccination strongly suggests that screening efforts and measures to
prevent transmission of vaccinia virus to contacts have been effective.
However, the experience of more vaccinees would have to be examined in
order to derive precise rates of how often the rare but most severe
adverse events occur. 22 Further, because more than half of the
individuals were

vaccinated during weeks 6 through 10, some of the adverse events that can
occur weeks after vaccination would not yet have been detected. Moreover,
not all planned vaccination monitoring systems were in place until more
than 3 weeks after vaccination began, and some jurisdictions report
ongoing difficulties in using the systems required by CDC. 23 Therefore
some of the experience to date may not have been captured by these
systems.

The data obtained as of week 10 are also insufficient to answer other
important safety questions. For example, although CDC had reported no
needlestick injuries as of late April, too few vaccinations have been
given

21 CDC announced on March 25, 2003, that volunteers with heart disease
should not be vaccinated until further notice. CDC also issued modified
smallpox vaccination program implementation materials that reflected this
new exclusion. Nine states announced that they were temporarily suspending
their vaccination programs until the new guidance was released. As of late
April, all but two of these states had resumed vaccinations. 22 DOD has
reported on experience with vaccinating over 350, 000 personnel as of
March 31, 2003, more than 8,000 of which were health care workers. As of
that date, DOD reports 82 adverse events and that 3 percent of vaccinees
took an average of 1. 5 days of sick leave.

DOD also reports that one vaccinee died of heart attack but states that
smallpox vaccination was unlikely to be the cause of death. Although the
DOD experience is informative and DOD is sharing information with HHS, the
military program differs from the civilian one in several respects that
limit the ability to generalize results from one program to the other. For
example, the DOD program is not voluntary, the military setting provides
more options for keeping vaccinated personnel separated from others, and
the

military population is on average younger than the general population.
Thus, for example, data from the DOD program could contribute to
understanding the rates of adverse events in properly screened vaccinees,
but would have less relevance for determining the effectiveness of the
educational and screening process for volunteers in the civilian program.
23 CDC developed the voluntary, Web- based Hospital Smallpox Vaccination
Monitoring

System for hospitals to track such indicators as workdays lost and
symptoms reported by vaccinees (ranging from mild to severe), but that
system was not available until February 18, 2003. Because this system is
designed to be used by hospitals to track vaccinees in real- time, it
could be part of an active surveillance system. In contrast to a passive
system, an active surveillance system would seek out the vaccinees to
collect data on them.

Page 14 GAO- 03- 578 National Smallpox Vaccination Program to precisely
estimate the rate of such injuries. Similarly, there are not enough data
to evaluate the effectiveness of the screening process, the

effectiveness of measures to prevent the spread of vaccinia virus, the
safety and effectiveness of VIG and cidofovir, and the effectiveness of
CDC*s distribution system for these investigational drugs. 24
Implementation of the smallpox vaccination program is facing two major

challenges. One is the program schedule, and the other is hesitancy on the
part of the two main groups involved in the program* those needed to
implement it and those needed to volunteer to be vaccinated.

Although these two groups have generally expressed support for the goals
of the program, they have concerns regarding the availability of resources
to implement the program, liability protection, safety, and workers*
compensation.

The program schedule is challenging and has placed heavy demands on CDC
and the jurisdictions (see table 3). CDC has developed a wide range of
implementation materials, which it has distributed through multiple
channels. These materials include guidance documents and educational and
training programs. The effort to produce materials quickly has led to
difficulties. Some of the materials that were distributed needed to be
revised, and some were inconsistent or untested. Some key materials were
not available until after the start of vaccination. For example, the
package of materials to be used to obtain informed consent for vaccination
from volunteers was first made available 8 days before the start of
vaccination, and the revised version was issued the day before vaccination
was to start.

The delayed availability of these materials created difficulties for those
trying to implement the program. In addition, CDC has provided conflicting
information about the precise method for administering the vaccine.
Further, the materials used to educate and screen volunteers were not
tested for comprehensibility to ensure that the screening process would
function as intended. Moreover, while CDC provided preliminary guidance
for adverse event monitoring in November, it hosted training on this issue
2 days before the program began and did not issue detailed guidance about
the adverse event monitoring system until 2 weeks after vaccination had
begun.

24 CDC reports that it shipped VIG to two states and made no shipments of
cidofovir. Major Challenges Are

Program Schedule and Hesitancy on Part of the Two Main Groups Involved in

Program Program Schedule Has Challenged CDC and the Jurisdictions

Page 15 GAO- 03- 578 National Smallpox Vaccination Program Table 3: Key
Events in National Smallpox Vaccination Program Time Line as of April 2003

Date Event

November 22, 2002  CDC issued guidance to jurisdictions for developing
plans for first stage of vaccination.

November 25, 2002  Homeland Security Act of 2002 enacted. December 9,
2002  Jurisdictional plans for first stage were due to CDC. December 12,
2002  CDC completed initial review of jurisdictional plans for

first stage. December 13, 2002  President announced National Smallpox
Vaccination

Program. December 18- 20, 2002  CDC- sponsored IOM Committee on Smallpox
Vaccination Program Implementation held first meeting.

January 16, 2003  CDC- sponsored IOM Committee on Smallpox Vaccination
Program Implementation issued first report. January 21, 2003 
Jurisdictions that requested vaccine began receiving

smallpox vaccine from CDC. January 24, 2003  Liability provisions of
Homeland Security Act of 2002

went into effect.

 HHS authorized start of vaccination program.

 First stage of vaccination began. February 13- 14, 2003  CDC- sponsored
IOM Committee on Smallpox Vaccination Program Implementation held second
meeting.

February 22, 2003  CDC*s original target date for completion of first
stage of vaccination.

March 21, 2003  CDC- sponsored IOM Committee on Smallpox Vaccination
Program Implementation issued second report. April 16, 2003  President
signed Emergency Wartime Supplemental Appropriations Act, 2003, which
includes additional

funding that can be used for smallpox vaccination program. April 24, 2003
 Congress presented H. R. 1770, Smallpox Emergency

Personnel Protection Act of 2003, to President for his signature.

Source: HHS, IOM, and the Library of Congress.

The program schedule has pressured the advisory process that CDC has set
up through IOM to help ensure that the program achieves its goals safely,
and the advisory committee has been concerned that the schedule might not
allow for a thorough evaluation of the program. Little time was

available for IOM*s Committee on Smallpox Vaccination Program
Implementation to undertake its first review and for CDC to respond to the
committee*s first report, which was issued 8 days before the start of the

Page 16 GAO- 03- 578 National Smallpox Vaccination Program vaccination
effort. 25 Consequently, many of the IOM recommendations that relate to
ensuring the safety of the program and facilitating

implementation had not been addressed at the start of vaccination. For
example, the IOM committee recommended that the materials to be used to
screen volunteers be pretested for comprehensibility before vaccination

started, but CDC responded that the schedule of the program precluded such
testing and initiated vaccination with the untested screening materials.
To ensure that the program proceeds safely, IOM also called for a thorough
evaluation by IOM and others following the first stage, prior to beginning
the second stage, as one of its key recommendations. CDC has

said that because of the need to implement the program rapidly there is no
distinction between the first and second stages and it does not expect to
identify a formal end to the first stage. Instead, CDC expects that
evaluation will be ongoing. In its second report, IOM reiterated its
concern that a too rapid expansion of the program could preclude the
opportunity to learn from the first stage before proceeding, and it again
urged CDC to

comprehensively evaluate the smallpox vaccination program and its outcomes
in order to improve its implementation and to protect the vaccinees and
the public. 26 The program schedule has also placed heavy demands on the
jurisdictions.

CDC required the jurisdictions to develop plans and targets for the first
stage of vaccination in less than 3 weeks. It provided some guidance on
the types of workers to be vaccinated on each type of team, but no
guidance for estimating the number of workers on teams or the number and
distribution of teams within a jurisdiction needed to provide sufficient
smallpox response capacity. 27 CDC expected the jurisdictions to be ready
to begin vaccinating less than 2 months after it approved their plans. The
jurisdictions are dependent on the guidance, educational and training
programs, and other materials produced by CDC, but these materials have
been changing since the program started. In accord with IOM*s
recommendation, some jurisdictions have also indicated that they would

25 Institute of Medicine, Committee on Smallpox Vaccination Program
Implementation,

Review of the Centers for Disease Control and Prevention*s Smallpox
Vaccination Program Implementation: Letter Report #1 (Washington, D. C.:
Jan. 16, 2003).

26 Institute of Medicine, Committee on Smallpox Vaccination Program
Implementation,

Review of the Centers for Disease Control and Prevention*s Smallpox
Vaccination Program Implementation: Letter Report #2 (Washington, D. C.:
Mar. 21, 2003).

27 CDC*s guidance on the types of workers to be vaccinated for health care
teams was not formalized until February 26, 2003.

Page 17 GAO- 03- 578 National Smallpox Vaccination Program benefit from an
evaluation of the first stage of the program before proceeding to the
second. CDC has indicated that the jurisdictions are to

proceed to the second stage as they determine they are ready to do so.
However, CDC has not provided guidance to help them plan and implement the
second stage of the program.

The smallpox vaccination program is to be implemented in the jurisdictions
by state and local public health authorities and individual hospitals. But
these implementers are hesitating to participate in the program because of
concerns about adequacy of resources and liability protection.

State and local health officials have stated that they are committed to
the safe and timely implementation of the smallpox vaccination program;
however, some have expressed concerns about the availability of resources
to implement this program. CDC initially provided no cost estimates, but
in testimony given in late January the Director estimated the basic cost
of administering the vaccine at $13 per vaccinee. 28 State and local
health officials assert that CDC has underestimated the cost of planning
and implementing the program. According to recent ASTHO and NACCHO
surveys, estimates of the cost of the whole first- stage vaccination
process* from planning through follow- up* range from $79 to $1,784 per
vaccinee. 29 ASTHO and NACCHO estimate that the average cost per vaccinee
is $265 and $204, respectively. CDC expects jurisdictions to

redirect funds made available through bioterrorism cooperative agreements
to pay for the smallpox vaccination program. However, state and local
health officials report that as of March 2003 most of these funds were
already committed to other bioterrorism activities; on average only 7
percent of these funds remain available. Thus in order to meet the

28 Statement of Director, Centers for Disease Control and Prevention,
Department of Health and Human Services, before the Senate Subcommittee on
Labor, Health and Human Services, Education and Related Agencies,
Committee on Appropriations, Hearing on Implementation of Smallpox
Vaccination Plan, 108th Cong., 1st sess. (Jan. 29, 2003), and Statement of
Director, Centers for Disease Control and Prevention, Department of Health
and Human Services, before the Senate Committee on Health, Education,
Labor, and Pensions, Hearing on the Administration*s Smallpox Vaccination
Plan: Challenges and Next Steps, 108th Cong., 1st sess. (Jan. 30, 2003).

29 In addition to the costs for administration of the vaccine, these
estimates include costs such as planning, education, training, screening,
communication, data management, vaccine clinic implementation, monitoring
of the vaccination site, surveillance, and treatment of adverse events.
Implementers and

Organizations That Represent Them Are Hesitating to Participate Because of
Concerns about Adequacy of Resources and Liability Protection

Page 18 GAO- 03- 578 National Smallpox Vaccination Program demands of the
smallpox vaccination program, they would need to divert funds supporting
other bioterrorism preparedness efforts and other public health services.
According to a recent NACCHO survey, about 79 percent

of local public health agency respondents reported that smallpox work is
adversely affecting their other bioterrorism preparedness efforts. About
53 percent reported that resources for other public health services such
as childhood immunization have been diverted to smallpox and other
bioterrorism efforts. ASTHO and some of the jurisdictions have told us
that although they are working to manage the first stage of smallpox
vaccination by diverting resources from other efforts, they anticipate
that it will be difficult if not impossible to find resources to implement
the second stage.

Organizations representing hospitals have indicated that hospitals are
generally committed to participating in the program, but many have
concerns about inadequate resources and about the balance between the
risks and benefits of vaccination. Hospitals are concerned that they may
have to assume the costs of implementing the program and note that they
lack adequate resources to do so. Hospitals include in their cost

calculations staff time to receive, administer, and follow up on
vaccinations; materials (e. g., forms) and supplies (e. g., bandages);
treatment for adverse events; and sick leave. Hospitals contend that the
$125 million previously provided by HRSA to states for use on the creation
of regional hospital response plans has proved insufficient for that
purpose and cannot cover the additional costs of the smallpox vaccination
program. However, resources are not the primary concern for all hospitals.
Hundreds of hospitals have opted not to participate in the smallpox
vaccination program at this time, contending that the risks outweigh the
benefits. Because the administration has characterized the threat of a
smallpox attack as being low, some hospitals estimate that the
countervailing risks to their patients of vaccinating hospital staff are
too great. These hospitals have indicated that they would reconsider their
decisions regarding participation should the risk of an attack increase or
cases of smallpox appear.

State and local health officials and hospital representatives are also
concerned about the scope of liability protection provided by the Homeland
Security Act of 2002 and have requested clarification. These officials are
requesting amendments to the act that would provide explicit liability
protection to vaccination program participants not specifically

protected by the act, such as public health departments and public health
workers. In addition, since the act provides no apparent protection for
entities that do not participate in the smallpox vaccination program,

Page 19 GAO- 03- 578 National Smallpox Vaccination Program hospital
representatives are concerned that a nonparticipating hospital, for
example, may not be protected if one of its health care workers who was

vaccinated elsewhere transmits vaccinia virus to one of its patients. 30
Many of the organizations that represent the public health and health care
workers who are needed to volunteer to be vaccinated have expressed their
willingness to participate in the smallpox vaccination program. However,
they have concerns about the possibility of experiencing adverse reactions
to the vaccine, ranging from fatigue to death, and the possibility of
transmitting the vaccinia virus to coworkers, family

members, or patients who could also face mild to severe complications.
They also have concerns about compensation for such injuries.

Volunteers are concerned about the adequacy of CDC*s screening process for
ruling out volunteers with conditions that may put them at greater risk
for severe reactions. For example, CDC recommends screening volunteers for
pregnancy or HIV, either of which can put a volunteer at greater risk.
However, volunteers do not believe they should have to undertake the
effort and expense to independently be tested for these conditions. The
provision of free testing for these risk factors as part of the screening
process is left to the discretion of the individual participating
jurisdictions and institutions. Volunteers are concerned that the lack of
free, routine testing could hinder identification of potential vaccinees
who may not be aware that they are pregnant or have HIV.

Volunteers who work in hospitals are concerned about the possibility of
transmission of vaccinia virus to their patients. CDC asserts that
following optimal infection control practices, such as using special
bandages and checking them daily, wearing clothing that covers the
vaccination site, and

hand washing, should essentially eliminate the risk of vaccinated health
care workers transmitting vaccinia virus to patients. Therefore, CDC
guidance does not require that vaccinated workers be kept separate from
patients until they can no longer transmit vaccinia virus. Volunteers are

uncertain whether the practices that CDC recommends will be sufficient.
Moreover, it is left to the individual participating jurisdictions and

30 Although the Secretary of HHS issued a letter implying protection for
such a hospital, the Secretary*s Declaration Regarding Administration of
Smallpox Countermeasures

indicates that hospitals would receive protection from liability under the
act if they designate employees to receive the vaccine. It is unclear
whether nonparticipating hospitals are in a position to make such
designations. 68 Fed. Reg. 4212, 4213 (2003). Volunteers and

Organizations That Represent Them Are Primarily Concerned about Safety and
Compensation for Injury

Page 20 GAO- 03- 578 National Smallpox Vaccination Program hospitals to
determine whether any leave taken to avoid contact with patients will be
paid for by the institution or the health care worker. Thus,

workers are concerned that they may lose income if they choose or are
required to be kept separate from patients.

Nursing associations and unions representing health care workers are
concerned about the two- pronged needle that CDC provides for use with the
smallpox vaccine, noting that it lacks safety features such as a
protective sheath available with other needles. 31 Health care workers
assert that the needles being used in the program may increase the risk of
needlesticks and exposure to the blood of vaccinees, both for those
administering the vaccine and for those along the path of needle disposal.
32 They have recommended that an alternative needle with safety features
be used instead. CDC has stated that it does not provide these alternative

needles because it has determined that no commercially available
safetyengineered two- pronged needle is an appropriate replacement for the
one included in the prepackaged kit it is distributing for the smallpox
vaccination program. Many of the organizations representing health care
workers have

expressed support for the goal of the program. However, in the literature
some individual physicians have questioned the program and raised concerns
that the risks of smallpox vaccination to workers, their families, and
patients may outweigh the benefits to society of preparedness for a
smallpox attack. Like some hospital administrators, these physicians are
recommending against vaccination at this time because program officials
have characterized the risk of an attack with smallpox as very low and
because there is a window in which vaccination is effective even after
exposure. They too have indicated that they would reconsider their
decision should the risk of smallpox increase.

The decision that health care workers face about whether to be vaccinated
is further complicated by potentially confusing educational and screening
31 The Dryvax vaccine kit approved for use by the Food and Drug
Administration (FDA) in the current smallpox vaccination program includes
100 two- pronged needles produced by the original manufacturer of the two-
pronged needle. A different manufacturer produces an FDA- approved two-
pronged safety needle, which has a plastic sheath that slides forward
after use to cover the tip of the needle and prevent injury.

32 See also U. S. General Accounting Office, Occupational Safety: Selected
Cost and Benefit Implications of Needlestick Prevention Devices for
Hospitals, GAO- 01- 60R (Washington, D. C.: Nov. 17, 2000).

Page 21 GAO- 03- 578 National Smallpox Vaccination Program materials for
volunteers. For example, some CDC materials specifically mention that
certain asthma patients who are taking immune- suppressing drugs should be
excluded. Other CDC materials screen out asthma

patients for different reasons, and still others do not mention asthma
patients at all. The differences in these materials may create confusion
for individuals with asthma who are trying to determine if they should be
excluded from vaccination. Also, because each jurisdiction can tailor some
of the guidance and materials provided by CDC according to its own
judgment, health care workers who live and work in separate jurisdictions
could receive inconsistent materials. For example, CDC does not recommend
against vaccinating individuals with an infant at home, but some
jurisdictions have decided to exclude such volunteers from vaccination
because of the seriousness of vaccinia virus in infants.

Organizations representing health workers are further concerned about
whether the costs to volunteers and their families would be covered should
they experience an adverse event and require time off from work, 33 need
medical treatment, become disabled, or die. HHS officials have stated that
they expect costs due to adverse events to be covered by sick leave,

workers* compensation, or individual, institutional, or jurisdictional
insurance policies. However, sick leave benefits vary from institution to
institution, and thus some workers may lose income. Health care coverage
also varies by institution and by policy, and thus not all volunteers are
guaranteed to have coverage for the costs of treating their adverse
reactions. For example, sick volunteers may have to pay co- payments for
medical care. In addition, ASTHO has surveyed states and found wide
variation in workers* compensation programs. Some states anticipate that
vaccinated volunteers will be covered under their workers* compensation
programs. However, given that workers* compensation eligibility is
determined on a case- by- case basis, many states refrain from
generalizing about such coverage. Even when applicable, workers*
compensation may provide only a percentage of salary and may not provide
coverage for individuals who received vaccinia virus from a vaccinated
volunteer.

33 Based on available data, CDC estimates that, among properly screened
volunteers, onethird of vaccinees will experience mild to moderate
reactions that may cause them to miss at least 1 day of work.

Page 22 GAO- 03- 578 National Smallpox Vaccination Program CDC and HHS
have been working to address the major challenges of program schedule and
hesitancy of participants, but to date they have not

been able to overcome them. With regard to the challenging program
schedule, CDC has reconsidered whether the initial targets for time for
completion and the total number of vaccinated health care workers are
required to achieve the goal of preparedness. Although CDC has said that
it expected the first stage to take more than 30 days, it has not set a
new

target for completion of the first stage. The Director of CDC has stated,
however, that it may not be necessary to vaccinate 500,000 health care
workers to achieve the goal of preparedness. She has indicated that as few
as 50,000 would suffice but has not explained how CDC arrived at that
number. CDC has not said how these workers should be organized and

distributed within the Smallpox Response Teams and across the nation. As
of late April, CDC had yet to set new targets for the first stage or to
request that the jurisdictions reconsider their plans to meet new targets.
Most of the jurisdictions have initiated the first stage of vaccination as
they had originally planned, although many have started later and have
vaccinated

fewer workers than they anticipated. Some jurisdictions have indicated
that they are attempting to follow their original plans while awaiting
resolution of the liability and compensation issues, and others have said
that they have begun to revise their targets downward for the first stage
without waiting for a request from CDC.

CDC has not said what the implications of this potential change in targets
for the first stage would be for the second stage. In addition, although
CDC announced that it would provide guidance for and request plans from
the jurisdictions for the second stage, it has not done so. Thus the
jurisdictions cannot determine how the workers to be vaccinated in the
second stage will be used to expand response capacity. Specifically, they
do not have guidance for how they should estimate their targets for the
types, number, and distribution of the additional workers to be
vaccinated. CDC and HHS have made some progress in addressing the two
major

concerns regarding resources and liability that are contributing to the
hesitancy of the implementers to participate in the program. CDC has
indicated that it is developing cost estimates and working to identify
additional resources to support implementation. In late March, HHS
announced that jurisdictions would be allowed to obtain up to 20 percent
of their 2003 federal bioterrorism preparedness funding immediately upon
approval of their application by CDC. One of the activities that this
funding may be requested for is smallpox vaccination. As of late April,
the application procedure for obtaining these funds had not been
specified. With regard to the liability concerns, CDC officials reported
that they have Major Challenges

Have Not Been Overcome and Continue to Affect Implementation

Page 23 GAO- 03- 578 National Smallpox Vaccination Program worked with HHS
to clarify the scope of the protection provided by the Homeland Security
Act of 2002. HHS issued a letter and a declaration from the Secretary, and
CDC published guidance and question- and- answer

documents. Nonetheless, implementers continue to have questions and say
they would prefer changes in the act itself to be assured of liability
protection.

In addition, Congress has taken steps to address implementers* concerns
about resources. On April 16, 2003, legislation was enacted appropriating
$100 million to the Public Health and Social Services Emergency Fund
intended to support implementation of the smallpox vaccination program. 34
However, because CDC still has not estimated costs, it is unclear whether
these funds will be sufficient to address the resource concerns of the
implementers. Furthermore, details on how funds will be made available to
jurisdictions have yet to be outlined.

Although CDC is working to address the volunteers* safety concerns that
are leading to their hesitancy to participate, some concerns have not been
resolved to the volunteers* satisfaction. CDC has decided not to change
its guidance on several safety issues important to volunteers but has
agreed to study some of these issues further. For example, it has not
changed its recommendation that health care workers do not need to be
routinely separated from patients while they are capable of transmitting
vaccinia virus because it maintains that if the recommended safety
measures, such

as special bandaging, are followed they will provide sufficient
protection. Further, CDC said that in making its decision about whether to
change the needles provided with the vaccine kits, it reviewed an HHS
evaluation of the alternative needle and concluded it was not safer. It
does not intend to change the needles at this time, but it does intend to
study the issue

further and in the meantime to monitor unintentional needlesticks.
Finally, CDC has not changed its recommendations regarding the provision
of testing for pregnancy and HIV as part of the screening process. Thus,
it is still at the discretion of jurisdictions to provide such testing
routinely and free of charge. CDC plans to maintain a registry of pregnant
women who may have been exposed to smallpox vaccine. Volunteers are,
however, still concerned about these safety issues. 34 Emergency Wartime
Supplemental Appropriations Act, 2003, Pub. L. No. 108- 11, 117 Stat.

559, 586 (2003). The Conference Committee Report states that this amount
is to assist state and local health authorities with costs associated with
the smallpox vaccination program. H. R. Conf. Rep. No. 108- 76, at 86
(2003).

Page 24 GAO- 03- 578 National Smallpox Vaccination Program Congress has
taken steps to address volunteers* compensation concerns. On April 24,
2003, it presented legislation to the President for his signature

to create a smallpox vaccination compensation program. This program would
provide benefits to public health and health care response team members
participating in a smallpox emergency response plan and public safety
personnel who are injured as a result of receiving the smallpox

vaccine. 35 Organizations representing public health and health care
workers have reacted positively to the new legislation. Other legislation
that addresses challenges facing the smallpox vaccination program in
addition to compensation, such as the safety concerns raised by
volunteers, has been introduced in the House of Representatives. 36 We
recognize that CDC and the jurisdictions have been trying to mount a

large effort in a short time. The National Smallpox Vaccination Program is
unprecedented and complex. Our public health system has not had experience
with either smallpox or smallpox vaccination in over 30 years. Further,
the context for the program is one of great uncertainty about both

the risk of a smallpox attack and the individual health risks involved in
vaccination. As might be expected with such a complex program, challenges
have been encountered. Implementers and volunteers have indicated that
they are unlikely to participate in the smallpox vaccination program in
the numbers needed to achieve the initial targets unless their major
concerns have been addressed. Because many concerns remain unresolved, it
may be difficult to achieve the initial targets for the first stage. It is
also too soon to

evaluate the impact on participation in the program of steps that have
been taken to provide additional resources and compensation for injuries.
However, CDC and some of the jurisdictions have indicated that as the
program unfolds and they learn more, they are less concerned about
achieving their initial targets and are considering revising them.
However, if the estimates are reduced for the numbers and types of
vaccinated health workers in Smallpox Response Teams, CDC would need to
provide guidance to ensure that smaller or fewer teams are organized and

35 Smallpox Emergency Personnel Protection Act of 2003, H. R. 1770, 108th
Cong. (2003) (enrolled). 36 Smallpox Vaccine Compensation and Safety Act
of 2003, H. R. 865, 108th Cong. (2003) (introduced). Conclusions

Page 25 GAO- 03- 578 National Smallpox Vaccination Program distributed in
a manner that will provide adequate response capacity* that is, the
capacity to effectively investigate an outbreak, care for patients, and
vaccinate members of the public. Setting revised targets for the total

number of vaccinations necessary would also provide a basis for more
accurately estimating what is needed to address the major concerns of
implementers and volunteers regarding resources, liability, and
compensation for adverse events.

A change in targets for the first stage would likely have implications for
the second stage. CDC has not provided guidance for determining how the
workers to be vaccinated in the second stage will be used to expand
response capacity. Thus it may be difficult for the jurisdictions to
estimate targets and plan implementation of the second stage.

With regard to the top priority for implementation* safety* the important
questions cannot yet be answered. To answer these questions and ensure
that program implementation proceeds through the first stage as safely as
possible, CDC and the jurisdictions need to collect and analyze data on an

ongoing basis. To date, not enough data have been collected to provide the
needed information. Answers to these questions are also important for
ensuring safe expansion to as many as 10 million additional volunteers in
the second stage of the program.

To ensure that the National Smallpox Vaccination Program successfully
develops adequate response capacity for a potential terrorist attack
involving smallpox, we recommend that the Director of CDC

 provide guidance and specific parameters to the jurisdictions for
estimating response capacity needs and work with the jurisdictions to
revise local and national targets for the first stage and  provide
guidance to the jurisdictions for implementing the second stage of the
program.

In its comments on a draft of this report, CDC concurred with our
recommendations, and indicated that it will issue guidance to assist
jurisdictions in their efforts to identify, train, and vaccinate
appropriate responders (see appendix I). CDC also provided technical
comments, which we incorporated as appropriate. Recommendations

Agency Comments

Page 26 GAO- 03- 578 National Smallpox Vaccination Program We are sending
copies of this report to the Director of CDC and other interested
officials. We will also provide copies to others upon request. In

addition, the report will be available at no charge on GAO*s Web site at
http:// www. gao. gov. If you or your staff have any questions about this
report, please call me at (202) 512- 7119. Another contact and key
contributors are listed in appendix II. Sincerely yours,

Marcia Crosse Acting Director, Health Care* Public

Health and Science Issues

Appendix I: Comments from the Centers for Disease Control and Prevention
Page 27 GAO- 03- 578 National Smallpox Vaccination Program Appendix I:
Comments from the Centers for Disease Control and Prevention

Appendix II: GAO Contact and Staff Acknowledgments

Page 29 GAO- 03- 578 National Smallpox Vaccination Program Michele Orza,
(202) 512- 6970 Other key contributors to this report are George Bogart,
Barbara

Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and Roseanne Price.
Appendix II: GAO Contact and Staff

Acknowledgments GAO Contact Acknowledgments

Related GAO Products Page 30 GAO- 03- 578 National Smallpox Vaccination
Program Bioterrorism: Preparedness Varied across State and Local
Jurisdictions.

GAO- 03- 373. Washington, D. C.: April 7, 2003.

Homeland Security: Voluntary Initiatives Are Under Way at Chemical
Facilities, but the Extent of Security Preparedness Is Unknown. GAO- 03-
439. Washington, D. C.: March 14, 2003.

Weapons of Mass Destruction: Observations on U. S. Threat Reduction and
Nonproliferation Programs in Russia. GAO- 03- 526T. Washington, D. C.:
March 5, 2003.

Food- Processing Security: Voluntary Efforts Are Under Way, but Federal
Agencies Cannot Fully Assess Their Implementation. GAO- 03- 342.
Washington, D. C.: February 14, 2003. Chemical and Biological Defense:
Observations on DOD*s Risk

Assessment of Defense Capabilities. GAO- 03- 137T. Washington, D. C.:
October 1, 2002.

Anthrax Vaccine: GAO*s Survey of Guard and Reserve Pilots and Aircrew.
GAO- 02- 445. Washington, D. C.: September 20, 2002.

Bioterrorism: The Centers for Disease Control and Prevention*s Role in
Public Health Protection. GAO- 02- 235T. Washington, D. C.: November 15,
2001.

Bioterrorism: Review of Public Health Preparedness Programs. GAO- 02-
149T. Washington, D. C.: October 10, 2001.

Bioterrorism: Public Health and Medical Preparedness. GAO- 02- 141T.
Washington, D. C.: October 9, 2001.

Bioterrorism: Coordination and Preparedness. GAO- 02- 129T. Washington, D.
C.: October 5, 2001.

Bioterrorism: Federal Research and Preparedness Activities. GAO- 01- 915.
Washington, D. C.: September 28, 2001.

Chemical and Biological Defense: Improved Risk Assessment and Inventory
Management Are Needed. GAO- 01- 667. Washington, D. C.: September 28,
2001. Related GAO Products

Related GAO Products Page 31 GAO- 03- 578 National Smallpox Vaccination
Program Occupational Safety: Selected Cost and Benefit Implications of
Needlestick Prevention Devices for Hospitals. GAO- 01- 60R. Washington, D.
C.: November 17, 2000. Food Safety: Agencies Should Further Test Plans for
Responding to

Deliberate Contamination. GAO/ RCED- 00- 3. Washington D. C.: October 27,
1999.

Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of
Chemical and Biological Attacks. GAO/ NSIAD- 99- 163. Washington, D. C.:
September 14, 1999.

Chemical and Biological Defense: Program Planning and Evaluation Should
Follow Results Act Framework. GAO/ NSIAD- 99- 159. Washington, D. C.:
August 16, 1999.

Combating Terrorism: Observations on Biological Terrorism and Public
Health Initiatives. GAO/ T- NSIAD- 99- 112. Washington, D. C.: March 16,
1999.

(290262)

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