oversight

Smallpox Vaccination: Implementation of National Program Faces Challenges

Published by the Government Accountability Office on 2003-04-30.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

             United States General Accounting Office

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



April 2003
             SMALLPOX
             VACCINATION
             Implementation of
             National Program
             Faces Challenges




GAO-03-578
                                               April 2003


                                               SMALLPOX VACCINATION

                                               Implementation of National Program
Highlights of GAO-03-578, a report to the
Chairman of the Committee on                   Faces Challenges
Governmental Affairs, U.S. Senate




Amid growing concerns about a                  Implementation of the smallpox vaccination program has proceeded more
potential smallpox attack, the                 slowly than CDC planned. Vaccinations are to be given to volunteers in two
Centers for Disease Control and                stages. CDC’s nationwide target for the first stage was an estimated 500,000
Prevention (CDC) is working with               health workers in 30 days. The number of health workers was based on the
62 state, local, and territorial               jurisdictions’ combined targets for their Smallpox Response Teams. In the
jurisdictions to implement the
civilian part of the National
                                               second stage, CDC plans to expand the program to as many as 10 million
Smallpox Vaccination Program.                  additional health workers and other emergency response personnel. On the
The goal is to increase the nation’s           official start date of vaccination, January 24, 2003, only one state began
response capacity by vaccinating               vaccinating. CDC reports that by week 10 (April 4, 2003) about 6 percent of
health workers for Smallpox                    the number of volunteers targeted for the first stage had been vaccinated.
Response Teams as quickly as is                Eight states accounted for about half of the vaccinees. Because of the slow
safely possible. A civilian program            pace, not enough data were generated by week 10 to evaluate whether the
using vaccination to bolster                   program is proceeding as safely as possible.
bioterrorism preparedness is
unprecedented, the health risks are            Implementation of the program is facing two major challenges. The first is
uncertain, and the public health               the program schedule, which placed heavy demands on CDC and the
system has had little recent
experience with smallpox. Safe
                                               jurisdictions. The second is hesitation on the part of the two main groups
implementation of such a program               needed to participate in the program—the state and local public health
will be complex. GAO was asked to              authorities and hospitals needed to implement it, and the health workers
examine implementation and its                 needed to volunteer to be vaccinated. Many implementers are concerned
challenges. GAO reviewed program               about insufficient resources to support the program and about liability
materials and data and interviewed             protection. Many potential volunteers are concerned about health risks to
CDC officials and representatives              themselves and their co-workers, families, and patients and about
of organizations involved.                     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
GAO recommends that the Director               participation in the program. Unless these efforts succeed in overcoming the
of CDC provide guidance to the                 hesitancy of the participants, it may be difficult to achieve the initial targets
jurisdictions for                              for the first stage. CDC has reconsidered the initial targets and said that as
                                               few as 50,000 vaccinated health workers nationwide would provide
•    estimating response capacity              sufficient response capacity. But as of late April, CDC had not set a new
     needs and revising targets for            nationwide target or requested that the 62 jurisdictions adjust their targets
     the first stage and                       for numbers and types of vaccinated health workers and distribution of
•    implementing the second                   response teams. CDC also has not said what the implications of this
     stage, that is, vaccination of
                                               potential change in targets for the first stage would be for the second stage.
     additional health workers and
     other emergency response                  In addition, although CDC announced that it would provide guidance for and
     personnel.                                request plans from the jurisdictions for the second stage, it has not yet done
                                               so.
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.
Contents


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




                       Page i                          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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Page ii                               GAO-03-578 National Smallpox Vaccination Program
United States General Accounting Office
Washington, DC 20548




                                   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).



                                   Page 1                                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, §
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 2                                 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 population8 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 3                                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
Results in Brief   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.


                   Page 4                          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 co-
workers, 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 5                           GAO-03-578 National Smallpox Vaccination Program
                         Since the terrorist attacks of September 11, 2001, and the subsequent
Background               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


Role of Vaccination in   The successful use of mass vaccinations to control deadly and debilitating
Public Health            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.


Smallpox Vaccination     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).




                         Page 6                                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   The National Smallpox Vaccination Program is unique in the history of
Vaccination Program     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.




                        Page 7                                 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 8                                    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 cidofovir14; 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 9                                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.


Initial Federal Funding for   The initial federal funding for the smallpox vaccination program came
the Smallpox Vaccination      from CDC’s bioterrorism preparedness funding. Since fiscal year 1999,
Program                       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).




                              Page 10                              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
Implementation Is   slowly than CDC planned. Because of the slow pace, not enough data have
Slower Than CDC     been generated to determine whether implementation is proceeding as
                    safely as possible according to the program’s goal.
Planned
                    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.




                    Page 11                               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              As of week 4        As of week 10
                          (January 24, 2003)       (February 21, 2003)       (April 4, 2003)
    Number
    (percent) of
    jurisdictions that
    had requested
    vaccinea                            27 (44%)            52 (84%)             55 (89%)
    Number
    (percent) of
    jurisdictions that
    had received
    vaccinea                            8 (13%)             52 (84%)             55 (89%)
    Number
    (percent) of
    jurisdictions that
    had initiated
    vaccinationsa                       1   (2%)            40 (65%)             54 (87%)
    Number
    (percent) of
    volunteers
    vaccinatedb                         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 events20 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 12                                     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 13                               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
Major Challenges Are     challenges. One is the program schedule, and the other is hesitancy on the
Program Schedule         part of the two main groups involved in the program—those needed to
                         implement it and those needed to volunteer to be vaccinated.
and Hesitancy on Part    Although these two groups have generally expressed support for the goals
of the Two Main          of the program, they have concerns regarding the availability of resources
                         to implement the program, liability protection, safety, and workers’
Groups Involved in       compensation.
Program
Program Schedule Has     The program schedule is challenging and has placed heavy demands on
Challenged CDC and the   CDC and the jurisdictions (see table 3). CDC has developed a wide range
Jurisdictions            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.




                         Page 14                              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 15                                          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 16                              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.


Implementers and            The smallpox vaccination program is to be implemented in the
Organizations That          jurisdictions by state and local public health authorities and individual
Represent Them Are          hospitals. But these implementers are hesitating to participate in the
                            program because of concerns about adequacy of resources and liability
Hesitating to Participate   protection.
Because of Concerns
about Adequacy of           State and local health officials have stated that they are committed to the
Resources and Liability     safe and timely implementation of the smallpox vaccination program;
Protection                  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.




                            Page 17                                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 18                        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


Volunteers and              Many of the organizations that represent the public health and health care
Organizations That          workers who are needed to volunteer to be vaccinated have expressed
Represent Them Are          their willingness to participate in the smallpox vaccination program.
                            However, they have concerns about the possibility of experiencing
Primarily Concerned about   adverse reactions to the vaccine, ranging from fatigue to death, and the
Safety and Compensation     possibility of transmitting the vaccinia virus to coworkers, family
for Injury                  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).




                            Page 19                               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 safety-
engineered 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 20                              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, one-
third of vaccinees will experience mild to moderate reactions that may cause them to miss
at least 1 day of work.




Page 21                              GAO-03-578 National Smallpox Vaccination Program
                     CDC and HHS have been working to address the major challenges of
Major Challenges     program schedule and hesitancy of participants, but to date they have not
Have Not Been        been able to overcome them. With regard to the challenging program
                     schedule, CDC has reconsidered whether the initial targets for time for
Overcome and         completion and the total number of vaccinated health care workers are
Continue to Affect   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
Implementation       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


                     Page 22                         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 23                               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
Conclusions   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).




              Page 24                              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
Recommendations       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
Agency Comments       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.




                      Page 25                          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




Page 26                         GAO-03-578 National Smallpox Vaccination Program
              Appendix I: Comments from the Centers for Disease Control and Prevention
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




Page 28                             GAO-03-578 National Smallpox Vaccination Program
                  Appendix II: GAO Contact and Staff
Appendix II: GAO Contact and Staff
                  Acknowledgments



Acknowledgments

                  Michele Orza, (202) 512-6970
GAO Contact
                  Other key contributors to this report are George Bogart, Barbara
Acknowledgments   Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and
                  Roseanne Price.




                  Page 29                              GAO-03-578 National Smallpox Vaccination Program
             Related GAO Products
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             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.




             Page 30                      GAO-03-578 National Smallpox Vaccination Program
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           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)
           Page 31                      GAO-03-578 National Smallpox Vaccination Program
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