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entitled 'Smallpox Vaccination: Implementation of National Program 
Faces Challenges' which was released on April 30, 2003.

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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 
nations 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. CDCs 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 programthe 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: (<1%); As of week 4: (February 21, 2003): 7,354; 
As of week 4: (<2%); As of week 10: (April 4, 2003): 31,297; As of week 
10: (6%).

Source: CDC.

[A] Percent of total of 62 jurisdictions.

[B] Percent of initial estimated target of 500,000.

[End of table]

Because progress has been slow, to date there are not enough data to 
precisely gauge indicators of the safety of implementation. For 
example, too few health care workers have been vaccinated and too 
little time has passed since their vaccination to precisely estimate 
rates of adverse events. Therefore it cannot yet be determined whether 
the rates are the same as would have been anticipated on the basis of 
historical data or different enough to trigger reconsideration of how 
the program should proceed. As of April 4, 2003, CDC had received 
reports of 68 moderate to severe adverse events[Footnote 20] and 250 
less severe adverse events, such as fever and rash, potentially related 
to smallpox vaccination. In addition, CDC had received reports that two 
volunteers who had been vaccinated died of heart attack, but CDC has 
not yet determined whether the deaths were related to the smallpox 
vaccine.[Footnote 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.[Footnote 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.[Footnote 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 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.[Footnote 24]

Major Challenges Are Program Schedule and Hesitancy on Part of the Two 
Main Groups Involved in Program:

Implementation of the smallpox vaccination program is facing two major 
challenges. One is the program schedule, and the other is hesitancy on 
the part of the two main groups involved in the program--those needed 
to implement it and those needed to volunteer to be vaccinated. 
Although these two groups have generally expressed support for the 
goals of the program, they have concerns regarding the availability of 
resources to implement the program, liability protection, safety, and 
workers' compensation.

Program Schedule Has Challenged CDC and the Jurisdictions:

The program schedule is challenging and has placed heavy demands on CDC 
and the jurisdictions (see table 3). CDC has developed a wide range of 
implementation materials, which it has distributed through multiple 
channels. These materials include guidance documents and educational 
and training programs. The effort to produce materials quickly has led 
to difficulties. Some of the materials that were distributed needed to 
be revised, and some were inconsistent or untested. Some key materials 
were not available until after the start of vaccination. For example, 
the package of materials to be used to obtain informed consent for 
vaccination from volunteers was first made available 8 days before the 
start of vaccination, and the revised version was issued the day before 
vaccination was to start. The delayed availability of these materials 
created difficulties for those trying to implement the program. In 
addition, CDC has provided conflicting information about the precise 
method for administering the vaccine. Further, the materials used to 
educate and screen volunteers were not tested for comprehensibility to 
ensure that the screening process would function as intended. Moreover, 
while CDC provided preliminary guidance for adverse event monitoring in 
November, it hosted training on this issue 2 days before the program 
began and did not issue detailed guidance about the adverse event 
monitoring system until 2 weeks after vaccination had begun.

Table 3: Key Events in National Smallpox Vaccination Program Time Line 
as of April 2003:

Date: November 22, 2002; Event: * CDC issued guidance to jurisdictions 
for developing plans for first stage of vaccination.

Date: November 25, 2002; Event: * Homeland Security Act of 2002 
enacted.

Date: December 9, 2002; Event: * Jurisdictional plans for first stage 
were due to CDC.

Date: December 12, 2002; Event: * CDC completed initial review of 
jurisdictional plans for first stage.

Date: December 13, 2002; Event: * President announced National Smallpox 
Vaccination Program.

Date: December 18-20, 2002; Event: * CDC-sponsored IOM Committee on 
Smallpox Vaccination Program Implementation held first meeting.

Date: January 16, 2003; Event: * CDC-sponsored IOM Committee on 
Smallpox Vaccination Program Implementation issued first report.

Date: January 21, 2003; Event: * Jurisdictions that requested vaccine 
began receiving smallpox vaccine from CDC.

Date: January 24, 2003; Event: * Liability provisions of Homeland 
Security Act of 2002 went into effect.; * HHS authorized start of 
vaccination program.; * First stage of vaccination began.

Date: February 13-14, 2003; Event: * CDC-sponsored IOM Committee on 
Smallpox Vaccination Program Implementation held second meeting.

Date: February 22, 2003; Event: * CDC's original target date for 
completion of first stage of vaccination.

Date: March 21, 2003; Event: * CDC-sponsored IOM Committee on Smallpox 
Vaccination Program Implementation issued second report.

Date: April 16, 2003; Event: * President signed Emergency Wartime 
Supplemental Appropriations Act, 2003, which includes additional 
funding that can be used for smallpox vaccination program.

Date: April 24, 2003; Event: * 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.

[End of table]

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 vaccination effort.[Footnote 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.[Footnote 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.[Footnote 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 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 Organizations That Represent Them Are Hesitating to 
Participate Because of Concerns about Adequacy of Resources and 
Liability Protection:

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

State and local health officials have stated that they are committed to 
the safe and timely implementation of the smallpox vaccination program; 
however, some have expressed concerns about the availability of 
resources to implement this program. CDC initially provided no cost 
estimates, but in testimony given in late January the Director 
estimated the basic cost of administering the vaccine at $13 per 
vaccinee.[Footnote 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.[Footnote 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 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, 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.[Footnote 30]

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

Many of the organizations that represent the public health and health 
care workers who are needed to volunteer to be vaccinated have 
expressed their willingness to participate in the smallpox vaccination 
program. However, they have concerns about the possibility of 
experiencing adverse reactions to the vaccine, ranging from fatigue to 
death, and the possibility of transmitting the vaccinia virus to 
coworkers, family members, or patients who could also face mild to 
severe complications. They also have concerns about compensation for 
such injuries.

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

Volunteers who work in hospitals are concerned about the possibility of 
transmission of vaccinia virus to their patients. CDC asserts that 
following optimal infection control practices, such as using special 
bandages and checking them daily, wearing clothing that covers the 
vaccination site, and hand washing, should essentially eliminate the 
risk of vaccinated health care workers transmitting vaccinia virus to 
patients. Therefore, CDC guidance does not require that vaccinated 
workers be kept separate from patients until they can no longer 
transmit vaccinia virus. Volunteers are uncertain whether the practices 
that CDC recommends will be sufficient. Moreover, it is left to the 
individual participating jurisdictions and 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.[Footnote 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.[Footnote 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 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,[Footnote 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.

Major Challenges Have Not Been Overcome and Continue to Affect 
Implementation:

CDC and HHS have been working to address the major challenges of 
program schedule and hesitancy of participants, but to date they have 
not been able to overcome them. With regard to the challenging program 
schedule, CDC has reconsidered whether the initial targets for time for 
completion and the total number of vaccinated health care workers are 
required to achieve the goal of preparedness. Although CDC has said 
that it expected the first stage to take more than 30 days, it has not 
set a new target for completion of the first stage. The Director of CDC 
has stated, however, that it may not be necessary to vaccinate 500,000 
health care workers to achieve the goal of preparedness. She has 
indicated that as few as 50,000 would suffice but has not explained how 
CDC arrived at that number. CDC has not said how these workers should 
be organized and distributed within the Smallpox Response Teams and 
across the nation. As of late April, CDC had yet to set new targets for 
the first stage or to request that the jurisdictions reconsider their 
plans to meet new targets. Most of the jurisdictions have initiated the 
first stage of vaccination as they had originally planned, although 
many have started later and have vaccinated fewer workers than they 
anticipated. Some jurisdictions have indicated that they are attempting 
to follow their original plans while awaiting resolution of the 
liability and compensation issues, and others have said that they have 
begun to revise their targets downward for the first stage without 
waiting for a request from CDC.

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

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

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.[Footnote 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.[Footnote 36]

Conclusions:

We recognize that CDC and the jurisdictions have been trying to mount a 
large effort in a short time. The National Smallpox Vaccination Program 
is unprecedented and complex. Our public health system has not had 
experience with either smallpox or smallpox vaccination in over 30 
years. Further, the context for the program is one of great uncertainty 
about both the risk of a smallpox attack and the individual health 
risks involved in vaccination.

As might be expected with such a complex program, challenges have been 
encountered. Implementers and volunteers have indicated that they are 
unlikely to participate in the smallpox vaccination program in the 
numbers needed to achieve the initial targets unless their major 
concerns have been addressed. Because many concerns remain unresolved, 
it may be difficult to achieve the initial targets for the first stage. 
It is also too soon to evaluate the impact on participation in the 
program of steps that have been taken to provide additional resources 
and compensation for injuries.

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

Recommendations:

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

* provide guidance and specific parameters to the jurisdictions for 
estimating response capacity needs and work with the jurisdictions to 
revise local and national targets for the first stage and:

* provide guidance to the jurisdictions for implementing the second 
stage of the program.

Agency Comments:

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

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:

Signed by Marcia Crosse

[End of section]

Appendix I: Comments from the Centers for Disease Control and 
Prevention:

DEPARTMENT OF HEALTH & HUMAN SERVICES	
Public Health Service:

Centers for Disease Control and Prevention (CDC) Atlanta GA 30333:

APR 24 2003:

Marcia G. Crosse, Ph.D. Acting Director:

Health Care - Public Health and Science Issues U.S. General Accounting 
Office:

441 G. Street, N.W., Room 5A14 Washington, D.C. 20548:

Dear Dr. Crosse:

The Centers for Disease Control and Prevention (CDC) is the lead agency 
for the national public health response to biological terrorism. 
Although a number of biological agents could be used to attack 
civilians, only a few, such as smallpox virus, have the potential to 
cause illness or panic which could overwhelm our present medical and 
public health systems.

Although smallpox was declared globally eradicated in 1980, there is 
concern that stores of smallpox virus may exist outside the two World 
Health Organization (WHO-) designated repository laboratories, which 
could be used as bioweapons. The emergence of a single case of smallpox 
(existing outside the two WHO-designated laboratories) would likely 
represent a bioterrorism release and would require an immediate and 
coordinated public health, medical, and law enforcement response to 
control the outbreak and to protect the public from any additional 
release.

In an effort to prepare the United States for a possible terrorist 
attack using smallpox virus, President Bush announced the smallpox 
program in December 2002. Since CDC initiated the smallpox vaccination 
program in January 2003, the vaccine has been administered to 32,644 
civilian healthcare and public health workers through April 13, 2003.

CDC appreciates the efforts by the General Accounting Office (GAO) to 
review the implementation of the smallpox vaccine program and elucidate 
the challenges facing the program. We have reviewed your draft report 
entitled, Smallpox Vaccination: Implementation ofNational Program 
Faces Challenges (GAO-03-578), and concur that CDC should provide 
further guidance on implementing smallpox preparedness activities 
within state and local health departments.

CDC previously provided states a template for mass vaccination to 
assist them in determining the numbers and types of staff needed to 
vaccinate their entire populations rapidly. In addition, the Advisory 
Committee on Immunization Practices (ACIP) provided guidance to states 
on the type of personnel needed to staff smallpox response teams and 
listed specific categories of personnel for healthcare response teams. 
ACIP believes hospitals are in the best position to determine the 
actual number of their staff needed to care for smallpox patients until 
additional vaccinated staff become available.

CDC will issue the "FY 2003 Continuation Guidance for the Bioterrorism 
Cooperative Agreement" to 62 state and local recipients. This document 
should help state and local jurisdictions complete efforts to identify, 
train, and vaccinate appropriate responders to ensure they are fully 
prepared to respond to a smallpox outbreak. The new guidance contains a 
summary of smallpox recipient activities and asks each grantee to 
determine the number of response personnel required to: (1) receive the 
smallpox vaccination before any smallpox outbreak occurs and (2) 
receive the vaccination in case there is an outbreak.

Additionally, the guidance requires state and local jurisdictions to 
enumerate:

the number of laboratories that have the capacity for (CDC) Laboratory 
Response Network (LRN)-validated testing and reporting of Variola 
major, Vaccinia, and Varicella zoster;

- The percentage of identified mass vaccination clinic staff and 
volunteers trained;

- Percentage of participants reached in tests of public information 
systems.

We appreciated the opportunity to collaborate with your staff to 
produce the report, and we are grateful for the opportunity to 
contribute data, information, and technical comments. If you have any 
questions, please contact Michael Sage, Deputy Director, Office of 
Terrorism Preparedness and Emergency Response, at (404) 639-7405.

Sincerely,

Julie Louise Gerberding, M.D., M.P.H.

Signed by Julie Louise Gerberding:

Director

[End of section]

Appendix II: GAO Contact and Staff Acknowledgments:

GAO Contact:

Michele Orza, (202) 512-6970:

Acknowledgments:

Other key contributors to this report are George Bogart, Barbara 
Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and Roseanne 
Price.

[End of section]

Related GAO Products:

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.

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.

FOOTNOTES

[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).

[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.

[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.

[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).

[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. 

[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.

[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.

[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).

[19] Due to rounding, the percents do not total to 100.

[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.

[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. 

[24] CDC reports that it shipped VIG to two states and made no 
shipments of cidofovir.

[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.

[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. 

[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).

[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).

[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.

[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).

[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).

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