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P U B L I C H E A L T H :
S M A L L P O X P R O G R A M
W E B E X C L U S I V E
22 October 2003
The Federal Smallpox Vaccination Program:
Where Do We Go From Here?
The United States should take
advantage of a pause in the program
to assess its performance and prospects.
by Daniel J. Kuhles and David
M. Ackman
ABSTRACT:
Despite the underwhelming response to the federal government’s initiative
to inoculate health care workers against smallpox, the Bush administration has
indicated that the program will continue and that it could be expanded to include
other health care providers, emergency service workers, and others deemed essential
for continuity of government. We discuss the reasons for the program’s
failure to date, outline recent advisories questioning the extent of the vaccination
effort, and suggest suspension of further vaccination efforts until certain
questions and issues are resolved.
Both the Institute of Medicine (IOM) and the Advisory Committee on Immunization
Practices (ACIP) recently issued recommendations for a pause in the federal
government’s smallpox vaccination program.1
The government planned to initially vaccinate approximately 500,000 hospital
and public health employees (phase I), who would serve on response teams capable
of treating and investigating known or suspected cases of smallpox without risk
of infecting themselves. After this initial effort, an additional ten million
first responders (fire, police, emergency medical technicians) and health care
workers would be vaccinated over a one-year period (phase II). In spite of efforts
from the highest levels of government and public health leadership, only 38,000
health care and public health workers have agreed to be vaccinated to date.
Nevertheless, the Centers for Disease Control and Prevention (CDC) has not retreated
from its initial goals and will soon be releasing a strategy to reaffirm the
importance of the smallpox program.2 In response
to the IOM recommendations, Jerome Hauer, head of public health preparedness
at the U.S. Department of Health and Human Services (HHS), stated, “We
are not pausing the program. The IOM has its opinions. We certainly understand
that. It doesn’t mean that we follow them.”3
Other administration officials and advisers have also called for renewed efforts
to reach the goal of vaccinating ten million people.4
Given the debate over future smallpox vaccinations, it is important to review
the recent experience, understand the reasons why the initial effort failed,
and consider the wisdom of renewing efforts to revive phase I or to proceed
with a wider vaccination strategy.
Background On Vaccination Strategies
The federal government has been concerned about U.S. vulnerability to bioterrorism
since at least the early 1990s.5 Immediately following
the 11 September 2001 attacks and the subsequent dispersal of anthrax through
the U.S. mail, the urgency of preparing for a bioterrorist attack (especially
one employing smallpox) grew. To allow for an unimpeded response to such an
attack, experts at the CDC and the ACIP initially proposed vaccinating 15,000
people. While presumably having the same intelligence assessments, many of our
allies in the war on terrorism decided against vaccination entirely or chose
to vaccinate only several hundred health care and public health workers.6
Eventually the administration decided to attempt to vaccinate 500,000 people,
which would provide for approximately 100 vaccinated health care workers at
each of the nation’s 5,000 hospitals.
The rationale behind the plan to vaccinate another ten million people is less
clear. Authorities might have been persuaded by mathematical models predicting
that an attack using aerosolized agent would overwhelm containment efforts using
ring vaccination strategies and result in thousands of deaths. Furthermore,
under such a scenario, having a well-vaccinated police and emergency services
force might combat the chaos or hysteria that would result from even a limited
smallpox outbreak. Polls taken just prior to President George W. Bush’s
announcement showed that two-thirds of Americans were ready to be vaccinated.7
Fire chiefs asked to be included in the decision-making process to vaccinate
first responders.8 Nevertheless, in contrast to
the decision to vaccinate health care workers, the jump to ten million people
was never explained in detail.
The federal vaccination effort, led by the CDC, began in January 2003 with training
of state and local health authorities. Because of the limited vaccine stock
and concerns over liability, the CDC directed that vaccinations be given solely
under the direction of public health departments. State departments of health
were responsible for identifying the types of personnel eligible for vaccination
and for oversight of the vaccine, while local health departments were responsible
for educating and vaccinating hospital workers and their own staffs and for
drawing up plans for mass vaccination of the entire population should smallpox
reappear. Public health agencies generally accepted phase I, in that it would
allow state and local governments to respond rapidly and effectively to the
first cases, although several hospitals and prominent physicians questioned
the plan.9
Experience In Nassau County
In Nassau County, New York, a large suburban community of 1.3 million people
with thirteen hospitals, only forty-five people have been vaccinated. Our experience
as a local health department suggests a number of reasons why health care and
public health workers have declined to be vaccinated. The CDC’s fear of
adverse events, especially progressive vaccinia, eczema vaccinatum, and post-vaccinial
encephalitis, led to the development of an elaborate process of screening and
informed consent. This entailed two separate screenings for contraindications,
viewing a video explaining possible adverse effects, and signing an informed-consent
form. The prevalence of contraindications, especially any history of skin conditions
in the vaccinee or household members, immediately disqualified 25–37 percent
of health workers.10 The ostensible purpose for
this procedure was to exclude people at greatest risk of adverse reactions,
but it also dissuaded a large number of people without contraindications who
had initially expressed interest in being vaccinated. In the Nassau County Department
of Health, of the ninety-five people asked to consider vaccination, forty-seven
initially expressed interest, but only eleven were actually vaccinated. Although
these numbers provide Nassau County with its own public health response team,
it seems likely that the lengthy exposure to discussions and illustrations of
severe vaccine reactions, and the possibility of infecting family members, simply
dissuaded many workers.
Experience Around The Country
Adverse reactions.
Many public health officials had expected more volunteers after the first group
had been successfully vaccinated. However, just the opposite has occurred, and
by the end of July 2003 the program was at a virtual standstill. In the U.S.
military program, which has vaccinated more than 450,000 healthy people, the
overall rate of adverse reactions is estimated at 32.0 per 100,000 doses.11
Although lower than expected, this adverse reaction rate is higher than those
of routine immunizations such as influenza (3.1 per 100,000) and measles, mumps,
and rubella (MMR, 16.3 per 100,000).12 Screening
for contraindications has been effective in preventing cases of eczema vaccinatum
and progressive vaccinia.
Even so, workers clearly remain concerned about the risks of the vaccine. Fears
may have been fed by weekly reports on the number of adverse reactions (as opposed
to rates).13 The CDC has catalogued more than 700
people adversely affected by the civilian program, including one case of postvaccinial
encephalitis, three cases of generalized vaccinia, twenty-one cases of inadvertent
autoinoculation, and twenty-two cases of myopericarditis.14
The unexpected cases of post-vaccination myopericarditis, angina, and myocardial
infarctions led to the addition of certain cardiac risk factors to the list
of contraindications and also could have diminished confidence in the CDC’s
ability to limit risk for vaccinees.15
Inadequate compensation.
Others might have refused to volunteer because of a perceived inadequacy of
compensation coverage. Under the Homeland Security Act, people must demonstrate
negligence in order to successfully recover compensation through the Federal
Tort Claims Act. Injuries to vaccinees that result from the vaccine itself are
channeled through state workers’ compensation programs, whose coverage
and adequacy vary widely.16 In New York State the
early confusion over compensation, and whether it would extend to family members,
might have created the impression that the government wanted individuals to
foot the bill for national bioterrorism preparedness. The federal government
has attempted to address these concerns by strengthening coverage through a
no-fault compensation fund. It remains to be seen whether this will address
the concerns of potential vaccinees.
Overblown risk of attack.
Skepticism over the true risk of an attack might have biased others against
vaccination. Smallpox is classified by the CDC as a category A bioterrorism
agent. Such agents are easily disseminated or transmitted person to person,
result in high mortality rates, may cause panic and public disruption, or require
special actions for preparedness.17
Despite the classification, the probability of a smallpox attack remains unknown.
The administration’s attempts to provide a balanced assessment of the risk
and probability of biological terrorism have been problematic; this underscores
the difficulty of risk communication for low-probability/high-impact health
threats.18 Statements were made to convey a sense
of the catastrophic consequences of a release and presumably to provide a rationale
for vaccination and accepting a small personal risk.19
Yet at the same time, the federal government was offering messages of reassurance
to the public. President Bush, in his December 2002 announcement, stated that
“there is no evidence that smallpox immediately threatens [the United States].”20
Furthermore, the claims about the immediacy of the smallpox threat were made
as the United States was making a case for war against Iraq. As of September
2003 none of the suspected biological or chemical weapons has been found, and
the reliability of prewar intelligence reports has been questioned.21
Post-exposure protection.
It is also possible that potential vaccinees believed that opportunities for
post-exposure vaccination provided sufficient protection to make vaccination
unnecessary before an actual smallpox event occurs. Smallpox control plans rely
heavily on the efficacy of post-exposure vaccination, and this information was
available to hospital workers at the time they were considering vaccination.
The result was that health care workers were either left confused and skeptical,
or were reassured and declined vaccination.
Emphasis
On Preparedness
The failure of phase I of the government’s smallpox vaccination program
makes the IOM’s March 2003 report on the program even more important. Rather
than specifying the number of vaccinees required locally or nationally, the
report emphasizes the importance of preparedness as the overall goal. The IOM’s
analysis is summarized as follows:
CDC’s goals for the
entire program (i.e. preparedness/capacity to respond, protection of those
who will investigate and treat suspected cases, and gaining experience with
vaccination) suggest that states may determine that once each local jurisdiction:
(1) has ready access to both a public health and health care response team;
(2) is capable of investigating an outbreak and caring for cases; and (3)
is ready to rapidly and safely vaccinate anyone else necessary—from additional
health care workers to the general public—it can conclude that it has
completed precautionary smallpox vaccination of critical personnel, thus accomplishing
one component of overall preparedness.22
In its June 2003 statement,
the ACIP also noted the need to view vaccination as just one part of overall
bioterrorism preparedness and emphasized the need for additional training of
both smallpox response teams and mass vaccination clinic staff, the development
of laboratory capacity, and the need to conduct drills and exercises to test
plans that have been developed.23 The ACIP statement
did not specify a target number of vaccinees for response teams, and the group
never endorsed the ten-million-person target for first responders.
Bill Foege, former director of the CDC, wrote that clinical suspicion leading
to early identification of cases, followed by ring vaccination and eventually
mass vaccination or prophylaxis (with a safer vaccine, it is hoped), were the
essential safeguards against an attack using smallpox or any other viral or
bacterial agent.24 Early CDC guidance on bioterrorism
preparedness highlighted the importance of surveillance, investigation, ring
vaccination, and communication; this was also reflected in the grant deliverables
given to health departments for bioterrorism preparedness.25
Vaccinating another ten million people would not greatly reduce the work
of local health departments in the event of mass vaccinations, nor would it
necessarily increase the capabilities for local response. Protecting public-safety
workers during the early phases of response would be possible by quickly vaccinating
exposed workers, then those who might become exposed, and by providing personal
protective equipment. Although it is prudent to plan and prepare for the worst
case, the communicability and pathogenesis of smallpox give health officials
a reasonable window to effectively prevent disease spread.26
Consequences For Local Health Departments
The plan’s consequences for local health departments in both financial
impact and public health preparedness have been largely absent from the national
debate.
Cost.
The cost of phase II has been estimated at between $600 million and $1 billion.27
If phase II goes forward, Nassau County will be expected to vaccinate approximately
45,000 people (0.46 percent of ten million first responders nationwide). We
estimate that the personnel costs to perform these vaccinations will approach
$460,000 for our county staff alone. Phase I was supported in part by the $1.08
billion allotted to states for general bioterrorism preparedness and public
health infrastructure, but this grant, made before the announcement of the smallpox
program, was intended to improve local infrastructure. Diverting funds to vaccination
defeated this purpose in part. If the government expands its vaccination efforts,
the $100 million dispensed for smallpox activities in fiscal year 2003–2004
will be insufficient to cover local costs. Because many state and local governments
face large budget deficits, proceeding to phase II would further redirect bioterrorism
funding away from critical preparedness activities such as developing quarantine
and isolation protocols, integrating surveillance and communication systems,
logistical preparation for the Strategic National Stockpile, and recruiting
and training volunteers for mass prophylaxis clinics.
Dilution of other public
health activities.
Supporters of the government’s bioterrorism plans have argued that the
federal funding is dual use in nature and will strengthen the public health
infrastructure. The activities undertaken and equipment purchased with bioterrorism
funds will certainly allow for local health departments to better respond to
emergencies. Yet the most severe problems in public health relate not to emergencies
but to altering behavior with adverse health outcomes, such as smoking, risky
sexual practices, physical inactivity, and poor diet. Like others in public
health, we are concerned that the high levels of bioterrorism funding will siphon
federal support from programs in these areas.28
Lessons From The Vaccination Effort
The current pause in the vaccination program provides the government with valuable
time to learn from the experience of phase I. From a policy perspective, many
of these lessons have been articulated by the IOM’s fourth report on the
vaccination program.29 Two of these lessons deserve
special emphasis.
Key lessons.
First, a defined minimum standard of preparedness is needed against which states
and localities can measure themselves. Every jurisdiction does not require the
same level of preparedness. The resources needed for a response to an attack
in the metropolitan New York region are different from those needed in a rural
area. Second, once the demand for vaccination is assessed, adequate fiscal and
human resources should be provided. The economic situation in hospitals is akin
to that in the public health sector. Institutions cannot afford to divert limited
staff from revenue-generating activities without compensation. Our experience
implementing the plan on a local level is also illustrative. The key message
we received from potential vaccinees was that civilians are unlikely to voluntarily
assume personal risk without good reason. Before performing an invasive procedure,
physicians are required to undertake an informed-consent process with the patient,
which spells out the indications, alternatives, and risks. The government owes
its health care, public health, and first-responder communities the same consideration,
particularly as it relates to the indications for vaccination, which thus far
has been lacking.
Reasons the program should
be suspended.
Recent guidance from the CDC suggests that phase II will be left to the discretion
of state and local authorities.30 Unfortunately,
allowing local discretion only increases the uncertainty over the need and role
of pre-event vaccinations. Instead, the CDC should suspend phase II of the smallpox
vaccination program for several reasons. First, it is unlikely that the next
ten million people will be more willing to accept the vaccine than hospital
and public health workers were. At least until we better understand the reasons
for health workers’ reluctance and take action to address these concerns,
delay is the only way to avert a second failed effort. Second, the federal government
needs to better explain the risk posed by smallpox and reconcile the difference
in approach between itself and other potential terrorist targets, such as Great
Britain. Extensive pre-event vaccination might make sense if we face the type
of attack played out in Dark Winter.31
Third, much of the initial debate over the program was shaped by the concern
that Iraq was developing weapons of mass destruction. While there is no way
to know if the absence of any such weapons is indicative of a lower risk for
the United States, the government should reexamine its initial analysis of the
need for phase II. Fourth, labor-intensive vaccination efforts will divert resources
from carrying out recommendations made by the IOM regarding other preparedness
activities and improving the public health infrastructure. Fifth, given the
media attention paid to controversies such as an association between MMR (a
well-established vaccine) and autism, the public could attribute the risks associated
with the current vaccine to a new, safer vaccine.
Our experience, similar to that of thousands of communities across the nation,
suggests that expansion of the smallpox vaccination program is likely to fail,
even while the need for it is under substantial question.
NOTES
1. Institute of Medicine, Review of the Centers for Disease
Control and Prevention’s Smallpox Vaccination Program Implementation,
Letter Report no. 3 (Washington: National Academies Press, 2003).
2. C. Connolly, “Focus on Smallpox Threat Revived; Experts
Say Immunization Program Is Crucial to Homeland Security,” Washington
Post, 17 July 2003.
3. M. Weinstock, “Medical Experts Renew Call to Freeze
Smallpox Vaccinations,” GovExec.com, 27 May 2003, www.govexec.com/dailyfed/0503/052703w1.htm
(28 May 2003).
4. Connolly, “Focus on Smallpox Threat Revived.”
5. J. Miller et al., Germs: Biological Weapons and America’s
Secret War (New York: Simon and Schuster, 2001), 162.
6. S. Ford, “NHS Staff to Get Smallpox Vaccine,” HealthyPages,
2 December 2002, www.healthypages.net/news.asp?newsid=2455
(15 April 2003).
7. D. McNeil, “Mixed Reactions to Inoculations but Doubts
Raised,” New York Times, 15 December 2002.
8. International Association of Fire Chiefs, Fire Chiefs
Guide to Smallpox Vaccination, 28 January 2003, www.iafc.org/downloads/smallpoxguide2003.pdf
(19 September 2003).
9. J. Gettleman, “Two Hospitals Refuse to Join Bush’s
Plan for Smallpox,” New York Times, 19 December 2002.
10. J. Bartlett et al, “Smallpox Vaccination in 2003:
Key Information for Clinicians,” Clinical Infectious Diseases 36,
no. 7 (2003): 883–902.
11. J.D. Grabenstein and W. Winkenwerder, “U.S. Military
Smallpox Vaccination Program Experience,” Journal of the American Medical
Association 289, no. 24 (2003): 3278–3282.
12. W. Zhou et al, “Surveillance for Safety after Immunization:
Vaccine Adverse Event Reporting System— United States, 1991–2001,”
Morbidity and Mortality Weekly Report 52, no. SS-1 (2003): 1–24.
13. A rate is a measure of some event, disease, or condition
in relation to a unit of population, along with some specification of time.
14. Centers for Disease Control and Prevention, “Update:
Adverse Events following Civilian Smallpox Vaccination—United States, 2003,”
Morbidity and Mortality Weekly Report 52, no. 34 (2003): 819–820.
15. CDC, “Supplemental Recommendations on Adverse Events
following Smallpox Vaccine in the Pre-Event Vaccination Program: Recommendations
of the Advisory Committee on Immunization Practices,” Morbidity and
Mortality Weekly Report 52, no. 13 (2003): 282–284.
16. National Association of City and County Health Officials,
“National Public Health Associations Urge Legislative Action to Protect
Smallpox Vaccine Volunteers,” Press Release, 7 March 2003, www.naccho.org/press66.cfm
(15 May 2003).
17. CDC, “Biological and Chemical Terrorism: Strategic
Plan for Preparedness and Response: Recommendations of the CDC Strategic Planning
Workgroup,” Morbidity and Mortality Weekly Report 49, no. RR-4 (2000):
1–14.
18. M.G. Morgan, “Risk Analysis and Management,”
Scientific American 269, no. 1 (1993): 32–35, 38–41.
19. D.A. Henderson, “CDC Telebriefing Transcript: HHS
Teleconference on Smallpox Policy,” 14 December 2002, www.cdc.gov/od/oc/media/transcripts/t021214.htm
(16 May 2003).
20. G.W. Bush, “President Delivers Remarks on Smallpox,”
Press Release/Transcript, 13 December 2002,
www.whitehouse.gov/news/releases/2002/12/20021213-7.html
(10 April 2003).
21. D. Jehl and J. Miller, “The Struggle for Iraq: The
Weapons; Draft Report Said to Cite No Success in Iraq Arms Hunt,” New
York Times, 24 September 2003.
22. IOM, Review of the Centers for Disease Control and Prevention’s
Smallpox Vaccination Program Implementation.
23. Advisory Committee on Immunization Practices, “Statement
on Smallpox Preparedness and Vaccination,” 18 June 2003, www.bt.cdc.gov/agent/smallpox/vaccination/pdf/acipjun2003.pdf
(1 August 2003).
24. W. Foege, “Can Smallpox Be as Simple as 1–2–3?”
Washington Post, 29 December 2002.
25. CDC, “Continuation Guidance for Cooperative Agreement
on Public Health Preparedness and Response for Bioterrorism—Budget Year
Four,” 2 May 2003, www.bt.cdc.gov/planning/continuationguidance/index.asp
(19 May 2003).
26. K.A. Sepkowitz, “How Contagious Is Vaccinia?”
New England Journal of Medicine 348, no. 5 (2003): 439–446.
27. R. Pilch, “Smallpox: Threat, Vaccine, and U.S. Policy,”
10 March 2003, cns.miis.edu/pubs/week/pdf/smallpox.pdf
(10 April 2003).
28. L.K. Altman and A. O’Connor, “Health Officials
Fear Local Impact of Smallpox Plan,” New York Times, 5 January 2003.
29. IOM, Review of the Centers for Disease Control and Prevention’s
Smallpox Vaccination Program Implementation, Letter Report no. 4 (Washington:
National Academies Press, 2003).
30. Weinstock, “Medical Experts Renew Call.”
31. Dark Winter was a fictional exercise conducted in June
2001 by the Johns Hopkins Center for Civilian Biodefense Strategies, which portrayed
a smallpox attack on the United States. Lessons from the exercise included the
following: (1) Leaders are unfamiliar with the potential consequences of an
attack; (2) policy decisions would be dependent upon the knowledge of public
health leaders; and (3) the lack of vaccine limited response options.
Daniel Kuhles (dkuhles{at}health.co.nassau.ny.us)
is assistant director, Division of Disease Control, Nassau County Department
of Health,in Mineola, New York. David Ackman is the county health commissioner.
10.1377/hlthaff.W3.503
©2003 Project HOPE–The People-to-People Health Foundation, Inc.
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