Smallpox Vaccination
Implementation of National Program Faces Challenges Gao ID: GAO-03-578 April 30, 2003Amid growing concerns about a potential smallpox attack, the Centers for Disease Control and Prevention (CDC) is working with 62 state, local, and territorial jurisdictions to implement the civilian part of the National Smallpox Vaccination Program. The goal is to increase the nation's response capacity by vaccinating health workers for Smallpox Response Teams as quickly as is safely possible. A civilian program using vaccination to bolster bioterrorism preparedness is unprecedented, the health risks are uncertain, and the public health system has had little recent experience with smallpox. Safe implementation of such a program will be complex. GAO was asked to examine implementation and its challenges. GAO reviewed program materials and data and interviewed CDC officials and representatives of organizations involved.
Implementation of the smallpox vaccination program has proceeded more slowly than CDC planned. Vaccinations are to be given to volunteers in two stages. CDC's nationwide target for the first stage was an estimated 500,000 health workers in 30 days. The number of health workers was based on the jurisdictions' combined targets for their Smallpox Response Teams. In the second stage, CDC plans to expand the program to as many as 10 million additional health workers and other emergency response personnel. On the official start date of vaccination, January 24, 2003, only one state began vaccinating. CDC reports that by week 10 (April 4, 2003) about 6 percent of the number of volunteers targeted for the first stage had been vaccinated. Eight states accounted for about half of the vaccinees. Because of the slow pace, not enough data were generated by week 10 to evaluate whether the program is proceeding as safely as possible. Implementation of the program is facing two major challenges. The first is the program schedule, which placed heavy demands on CDC and the jurisdictions. The second is hesitation on the part of the two main groups needed to participate in the program--the state and local public health authorities and hospitals needed to implement it, and the health workers needed to volunteer to be vaccinated. Many implementers are concerned about insufficient resources to support the program and about liability protection. Many potential volunteers are concerned about health risks to themselves and their co-workers, families, and patients and about compensation for adverse events and lost income. Program officials and Congress have been working to address some of the major challenges but it is too soon to evaluate the impact of these efforts on participation in the program. Unless these efforts succeed in overcoming the hesitancy of the participants, it may be difficult to achieve the initial targets for the first stage. CDC has reconsidered the initial targets and said that as few as 50,000 vaccinated health workers nationwide would provide sufficient response capacity. But as of late April, CDC had not set a new nationwide target or requested that the 62 jurisdictions adjust their targets for numbers and types of vaccinated health workers and distribution of response teams. CDC also has not said what the implications of this potential change in targets for the first stage would be for the second stage. In addition, although CDC announced that it would provide guidance for and request plans from the jurisdictions for the second stage, it has not yet done so.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-03-578, Smallpox Vaccination: Implementation of National Program Faces Challenges
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Report to the Chairman, Committee on Governmental Affairs, U.S. Senate:
United States General Accounting Office:
GAO:
April 2003:
SMALLPOX VACCINATION:
Implementation of National Program Faces Challenges:
National Smallpox Vaccination Program:
GAO-03-578:
GAO Highlights:
Highlights of GAO-03-578, a report to the Chairman of the Committee on
Governmental Affairs, U.S. Senate
Why GAO Did This Study:
Amid growing concerns about a potential smallpox attack, the Centers
for Disease Control and Prevention (CDC) is working with 62 state,
local, and territorial jurisdictions to implement the civilian part of
the National Smallpox Vaccination Program. The goal is to increase the
nation‘s response capacity by vaccinating health workers for Smallpox
Response Teams as quickly as is safely possible. A civilian program
using vaccination to bolster bioterrorism preparedness is
unprecedented, the health risks are uncertain, and the public health
system has had little recent experience with smallpox. Safe
implementation of such a program will be complex. GAO was asked to
examine implementation and its challenges. GAO reviewed program
materials and data and interviewed CDC officials and representatives of
organizations involved.
What GAO Found:
Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. Vaccinations are to be given to volunteers in
two stages. CDC‘s nationwide target for the first stage was an
estimated 500,000 health workers in 30 days. The number of health
workers was based on the jurisdictions‘ combined targets for their
Smallpox Response Teams. In the second stage, CDC plans to expand the
program to as many as 10 million additional health workers and other
emergency response personnel. On the official start date of
vaccination, January 24, 2003, only one state began vaccinating. CDC
reports that by week 10 (April 4, 2003) about 6 percent of the number
of volunteers targeted for the first stage had been vaccinated. Eight
states accounted for about half of the vaccinees. Because of the slow
pace, not enough data were generated by week 10 to evaluate whether the
program is proceeding as safely as possible.
Implementation of the program is facing two major challenges. The first
is the program schedule, which placed heavy demands on CDC and the
jurisdictions. The second is hesitation on the part of the two main
groups needed to participate in the program”the state and local public
health authorities and hospitals needed to implement it, and the health
workers needed to volunteer to be vaccinated. Many implementers are
concerned about insufficient resources to support the program and about
liability protection. Many potential volunteers are concerned about
health risks to themselves and their co-workers, families, and patients
and about compensation for adverse events and lost income.
Program officials and Congress have been working to address some of the
major challenges but it is too soon to evaluate the impact of these
efforts on participation in the program. Unless these efforts succeed
in overcoming the hesitancy of the participants, it may be difficult to
achieve the initial targets for the first stage. CDC has reconsidered
the initial targets and said that as few as 50,000 vaccinated health
workers nationwide would provide sufficient response capacity. But as
of late April, CDC had not set a new nationwide target or requested
that the 62 jurisdictions adjust their targets for numbers and types of
vaccinated health workers and distribution of response teams. CDC also
has not said what the implications of this potential change in targets
for the first stage would be for the second stage. In addition,
although CDC announced that it would provide guidance for and request
plans from the jurisdictions for the second stage, it has not yet done
so.
What GAO Recommends:
GAO recommends that the Director of CDC provide guidance to the
jurisdictions for
* estimating response capacity needs and revising targets for the first
stage and
* implementing the second stage, that is, vaccination of additional
health workers and other emergency response personnel.
CDC concurred with these recommendations.
www.gao.gov/cgi-bin/getrpt?GAO-03-578.
To view the full report, including the scope
and methodology, click on the link above.
For more information, contact Marcia Crosse at (202) 512-7119.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Implementation Is Slower Than CDC Planned:
Major Challenges Are Program Schedule and Hesitancy on Part of the Two
Main Groups Involved in Program:
Major Challenges Have Not Been Overcome and Continue to Affect
Implementation:
Conclusions:
Recommendations:
Agency Comments:
Appendix I: Comments from the Centers for Disease Control
and Prevention:
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Acknowledgments:
Related GAO Products:
Tables:
Table 1: Targets for the First Stage of the Program, as Initially
Proposed by the 54 Jurisdictions with CDC-Approved Plans:
Table 2: Status of National Smallpox Vaccination Program
Implementation, Day 1 through Week 10:
Table 3: Key Events in National Smallpox Vaccination Program Time Line
as of April 2003:
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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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.[Footnote 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.[Footnote 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.[Footnote 3]
CDC planned for the 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.[Footnote 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.[Footnote 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.[Footnote
6]
CDC is implementing the smallpox vaccination program in collaboration
with 62 state, local, and territorial governments.[Footnote 7] Thus the
plan for the program is embodied in multiple federal guidance documents
and recommendations, the individual CDC-approved plans of the 62
jurisdictions, and the plans of thousands of individual hospitals
involved. Each of the jurisdictions and hospitals has tailored its
first-stage planning and targets for numbers and distribution of teams
and numbers and types of health workers on the teams to its own
particular circumstances. CDC has defined the program's targets for
national preparedness as the sum of the targets set by the
jurisdictions in their plans.
A large-scale public vaccination program against a disease that no
longer exists as a natural threat is unprecedented and presents many
challenges. The relatively small and known risks of adverse events
associated with vaccines in past vaccination programs have been
justified on the basis of the need to reduce a known incidence of
disease in the population. For smallpox, such justification no longer
exists. Both the nature and rates of adverse events to be expected in
today's population[Footnote 8] and the risk of a bioterrorist attack
are uncertain, making the development and safe implementation of a
program of smallpox vaccination especially challenging.
In recognition of the potential difficulties in implementation of the
smallpox vaccination program, you requested that we determine (1) how
implementation of the civilian part of the program is proceeding, (2)
what challenges have been encountered, and (3) whether these challenges
have been addressed.
In carrying out our work, we conducted a literature review and examined
program-related materials and data and interviewed officials and
representatives involved in the program. Specifically, we obtained
program-related materials and data on plans, numbers of health workers
vaccinated, shipments of vaccine, adverse events reported, and other
relevant information from CDC through the first 10 weeks of
vaccination. We obtained data about the jurisdictions from the
Association of State and Territorial Health Officials (ASTHO) and the
National Association of County and City Health Officials (NACCHO). We
reviewed relevant materials from the Department of Defense (DOD), the
Institute of Medicine (IOM), WHO, the 62 jurisdictions, and 25
organizations representing state and local health authorities,
hospitals, physicians, 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.
Results in Brief:
Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. On the start date of vaccination, most of the
62 jurisdictions were not prepared to begin vaccinating volunteers:
More than half had not yet requested vaccine from CDC, and most of the
remaining jurisdictions had requested that their vaccine not be shipped
until after the start date. On the first day, only one state began
vaccinating. As many jurisdictions had projected in their individual
plans, the vaccination of health workers in the first stage of the
program is taking longer than the 30 days set by CDC as an initial
target. CDC reports that by week 10 about 6 percent of the initial
target (a total of 31,297 health workers) had been vaccinated in 54 of
the 62 jurisdictions. Eight states accounted for about half of the
vaccinees. As of week 10, there are not enough data to precisely
estimate rates of adverse events and other indicators of program
safety.
Implementation of the program is facing two major challenges--the
program schedule, which placed heavy demands on CDC and the
jurisdictions, and hesitation on the part of the two main groups needed
to participate. CDC developed extensive guidance, training and
educational programs, and other materials to support implementation,
but the schedule made it difficult for the agency to resolve all issues
prior to the start of vaccination. For example, a CDC data system for
hospitals to track adverse reactions was not available until more than
3 weeks after vaccinations had begun. The jurisdictions had less than 3
weeks to develop their plans and less than 2 months to prepare to begin
vaccination. Although generally supportive of the program's goal, the
two major groups of participants--the state and local public health
authorities and hospitals needed to implement it, and the health
workers needed to volunteer to be vaccinated--have concerns and
therefore are hesitating to participate. 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.
Background:
Since the terrorist attacks of September 11, 2001, and the subsequent
anthrax cases, there has been heightened public awareness and fear of
potential bioterrorist attacks, including an attack involving smallpox.
Smallpox is a contagious disease whose symptoms include fever and a
distinctive progressive skin rash. It is fatal in about 30 percent of
cases and is considered by CDC to be one of the six biological agents
that pose the greatest potential threat for adverse public health
impact and have a moderate to high potential for large-scale
dissemination.[Footnote 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.[Footnote 10]
Role of Vaccination in Public Health:
The successful use of mass vaccinations to control deadly and
debilitating diseases worldwide is one of the great public health
achievements of the past century. Routine immunization programs have
been built around safe and effective vaccines targeted at smallpox,
poliomyelitis, measles, rubella, tetanus, diphtheria, influenza, and
other infectious diseases. Although vaccination programs have provided
great benefits, they also carry some risk. Most vaccines, like most
medications, have a very small rate of severe adverse reactions.
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.
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.[Footnote 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.[Footnote 12]
Previous experience with the vaccine has shown that it spreads to other
parts of the vaccinee's body at a rate of 25 to 532 per million
individuals vaccinated and spreads from the vaccinee to others at a
rate of 20 to 60 per million.
The National Smallpox Vaccination Program:
The National Smallpox Vaccination Program is unique in the history of
civilian immunization programs in that it is not a public health
program in the traditional sense but rather a program of bioterrorism
preparedness. The population to be vaccinated in the first and second
stages of the civilian part of the program is not the general public as
in traditional programs, but key public health, health care, and
emergency response workers. Smallpox Response Teams vaccinated in the
first stage would receive vaccine not solely to protect their own
health but primarily to increase the nation's capacity to respond to a
smallpox attack by investigating an outbreak, caring for patients, and
vaccinating members of the public who may have been exposed. Because
vaccination soon after exposure can prevent or reduce the severity of
the disease, planners project that there will be sufficient time for
these key workers to vaccinate members of the public as needed to
contain a smallpox outbreak after it has been recognized.
CDC's guidance allows the 62 jurisdictions some flexibility in forming
their Smallpox Response Teams. For example, it provides recommendations
for 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.[Footnote 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:
Planned duration of first stage (in days); Targets: Average: 55;
Targets: Minimum: 7; Targets: Maximum: 126.
Planned number of Public Health Smallpox Response Teams; Targets:
Average: 21; Targets: Minimum: 1; Targets: Maximum: 107.
Planned number of Healthcare Smallpox Response Teams; Targets: Average:
92; Targets: Minimum: 2; Targets: Maximum: 375.
Planned number of volunteers to be vaccinated; Targets: Average: 7,997;
Targets: Minimum: 323; Targets: Maximum: 40,000.
Planned number of volunteers to be vaccinated per million population;
Targets: Average: 1,903; Targets: Minimum: 81; Targets: Maximum: 8,772.
Source: GAO analysis of CDC data.
Note: The plans for the territories had not been approved as of January
2003.
[End of table]
CDC has said that safety is the top priority in implementing this
program. To enable jurisdictions to implement this program in the
safest manner possible, the agency has provided guidance and materials
for critical elements of the program, including:
* education and training of health workers who will be administering
the vaccinations;
* education and screening of volunteers to rule out those who may be at
greater risk for severe reactions;
* care of the site of vaccination on the vaccinee's body to prevent
secondary infection or transmission to others;
* monitoring of adverse events;
* distribution of the two investigational drugs used in treating
certain adverse reactions caused by the vaccine, vaccinia immune
globulin (VIG) and cidofovir[Footnote 14]; and:
* systems for ongoing collection, management, and analysis of program
data--including adverse events,[Footnote 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,[Footnote 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
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 Smallpox Vaccination Program:
The initial federal funding for the smallpox vaccination program came
from CDC's bioterrorism preparedness funding. Since fiscal year 1999,
HHS has distributed funding for bioterrorism preparedness to state and
local health departments in the 62 jurisdictions primarily through
CDC's Bioterrorism Preparedness and Response Program.[Footnote 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.[Footnote 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,
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 Is Slower Than CDC Planned:
Implementation of the smallpox vaccination program has proceeded more
slowly than CDC planned. Because of the slow pace, not enough data have
been generated to determine whether implementation is proceeding as
safely as possible according to the program's goal.
Specifically, vaccination of health workers in the first stage has
proceeded slowly. CDC's initial target date for completion of the first
stage has passed. As of the start date for vaccination, January 24,
2003, most of the jurisdictions were not ready to begin vaccinating:
More than half of the jurisdictions had not yet requested vaccine from
CDC, and most of the remaining jurisdictions had requested that their
vaccine not be shipped until after the start date. (See table 2.) On
the first day, four health care workers in one jurisdiction--
Connecticut--were vaccinated. As many jurisdictions had projected in
their individual plans, the vaccination of health workers in the first
stage of the program is taking longer than the 30 days set by CDC as an
initial target. By the end of the tenth week, April 4, 2003, 7
jurisdictions had yet to request vaccine, but the rest had requested
and received their shipments. Although CDC reported that a total of
31,297 health workers (about 6 percent of the initial target) had been
vaccinated in 54 of the 62 jurisdictions by week 10, about half of
those vaccinated were distributed across eight states: Florida,
Minnesota, Missouri, Nebraska, North Carolina, Ohio, Tennessee, and
Texas. Sixty-two percent of those vaccinated were Healthcare Smallpox
Response Team members, and 33 percent were Public Health Smallpox
Response Team members; the remaining 4 percent were "other," which
includes public officials who are not part of a Smallpox Response
Team.[Footnote 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.
Table 2: Status of National Smallpox Vaccination Program
Implementation, Day 1 through Week 10:
Number (percent) of jurisdictions that had requested vaccine[A]; As of
day 1: (January 24, 2003): 27; As of day 1: (44%); As of week 4:
(February 21, 2003): 52; As of week 4: (84%); As of week 10: (April 4,
2003): 55; As of week 10: (89%).
Number (percent) of jurisdictions that had received vaccine[A]; As of
day 1: (January 24, 2003): 8; As of day 1: (13%); As of week 4:
(February 21, 2003): 52; As of week 4: (84%); As of week 10: (April 4,
2003): 55; As of week 10: (89%).
Number (percent) of jurisdictions that had initiated vaccinations[A];
As of day 1: (January 24, 2003): 1; As of day 1: (2%); As of week 4:
(February 21, 2003): 40; As of week 4: (65%); As of week 10: (April 4,
2003): 54; As of week 10: (87%).
Number (percent) of volunteers vaccinated[B]; As of day 1: (January 24,
2003): 4; As of day 1: (
