Smallpox Vaccination: Review of the Implementation of the
Military Program (01-DEC-03, GAO-04-215R).
On December 13, 2002, in response to growing concern that a
terrorist or hostile regime might have access to the smallpox
virus and attempt to use it against the American people, the
President announced the formation of the National Smallpox
Vaccination Program. The program has two components--one
responsible for vaccinating civilians and another responsible for
vaccinating military personnel. The Centers for Disease Control
and Prevention (CDC) is responsible for implementing the civilian
component of the National Smallpox Vaccination Program. The
Department of Defense (DOD) is responsible for implementing the
military component of the program. Because the National Smallpox
Vaccination Program is the nation's first large-scale
bioterrorism defense program, Congress asked us to assess the
implementation of the program in order to aid the development of
future programs. In April 2003, we reported on the implementation
of the civilian component of the National Smallpox Vaccination
Program. In this report, we describe (1) how DOD implemented its
smallpox vaccination program and (2) the steps DOD took to
facilitate the implementation of the program.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-04-215R
ACCNO: A08960
TITLE: Smallpox Vaccination: Review of the Implementation of the
Military Program
DATE: 12/01/2003
SUBJECT: Counterterrorism
Military personnel
Health care programs
Immunization programs
Infectious diseases
Program evaluation
Chemical and biological agents
National preparedness
National Smallpox Vaccination Program
******************************************************************
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GAO-04-215R
United States General Accounting Office Washington, DC 20548
December 1, 2003
The Honorable Susan M. Collins
Chairman
Committee on Governmental Affairs
United States Senate
Subject: Smallpox Vaccination: Review of the Implementation of the
Military Program
Dear Chairman Collins:
On December 13, 2002, in response to growing concern that a terrorist or
hostile regime might have access to the smallpox virus and attempt to use
it against the American people, the President announced the formation of
the National Smallpox Vaccination Program. The program has two
components-one responsible for vaccinating civilians and another
responsible for vaccinating military personnel. The Centers for Disease
Control and Prevention (CDC) is responsible for implementing the civilian
component of the National Smallpox Vaccination Program. The Department of
Defense (DOD) is responsible for implementing the military component of
the program.
Because the National Smallpox Vaccination Program is the nation's first
large-scale bioterrorism defense program, you asked us to assess the
implementation of the program in order to aid the development of future
programs. In April 2003, we reported on the implementation of the civilian
component of the National Smallpox Vaccination Program.1 In this report,
we describe (1) how DOD implemented its smallpox vaccination program and
(2) the steps DOD took to facilitate the implementation of the program.
To describe how DOD implemented its smallpox vaccination program and the
steps it took to facilitate the implementation of the program, we reviewed
DOD's planning guidance for the program, implementation plans related to
the program, training for vaccinators, and educational materials for
vaccinees. We also reviewed CDC guidelines and documents related to the
civilian program that were used in the military's smallpox vaccination
program. We interviewed Army, Navy, Air Force, and Marine officials and
reviewed written responses to our questions provided by the
1U.S. General Accounting Office, Smallpox Vaccination: Implementation of
the National Program Faces Challenges, GAO-03-578 (Washington, D.C.: Apr.
30, 2003).
Army National Guard and the Coast Guard. We observed the vaccination
process at Andrews Air Force Base. In addition, we reviewed the Institute
of Medicine's recommendations and CDC's and DOD's policies for monitoring
and recording adverse health events2 following the vaccinations. We
obtained information about adverse health events from DOD and CDC. We
performed our work from April through November 2003 in accordance with
generally accepted government auditing standards.
Results in Brief
DOD implemented its smallpox vaccination program in stages and took steps
to prevent and monitor adverse health events following the vaccinations.
The first stage of the smallpox vaccination program consisted of a pilot
program that began in December 2002, during which DOD vaccinated and
monitored the health of military personnel at four sites. According to DOD
officials, the intent of the pilot program was to assess DOD's procedures
for administering the vaccine and monitor the frequency of adverse health
reactions. After completion of the pilot program, DOD began full
implementation of the smallpox vaccination program in mid-January 2003.
DOD vaccinated its personnel in stages-prioritizing its personnel
according to which groups would be most likely to respond first to a
smallpox outbreak. As of October 2003, DOD had vaccinated more than
500,000 military personnel. In order to minimize the number of people who
might have adverse reactions to the vaccine, DOD followed CDC guidelines
by screening personnel for health conditions that precluded them from
receiving smallpox vaccinations. To monitor adverse health events
following the vaccinations, DOD used two health information tracking
systems, CDC's Vaccine Adverse Event Reporting System (VAERS) and DOD's
Defense Medical Surveillance System (DMSS).
To facilitate its vaccination program, DOD took steps to ensure the
availability of the vaccine and educate its personnel. Specifically, DOD
established practices to limit the amount of vaccine that could be wasted
or contaminated. For example, to ensure the vaccine was not wasted due to
a loss of potency, its temperature was monitored with a computer chip to
ensure that the vaccine was maintained at the proper temperature during
shipment. DOD also facilitated the implementation of its vaccination
program by educating its personnel-both those who administered the vaccine
and those who received it-on related issues, such as vaccination
procedures and potential adverse health reactions.
In commenting on a draft of this report, DOD agreed with our findings.
2In this report we use the term "adverse health event" to refer to a
health condition that occurred after vaccination and may or may not be
attributable to the vaccine. When adverse health events are diagnosed as
causally related to the vaccine, we use the term "adverse health
reactions."
Background
Smallpox is a contagious disease that is generally spread through
prolonged face-toface contact, but it can also be spread through direct
contact with infected bodily fluids or contaminated objects. Smallpox
symptoms include fever and a distinctive skin rash. There is no known cure
for smallpox, and it is fatal in about 30 percent of cases. Immunity to
the virus that causes smallpox-the variola virus-is conferred through
inoculation with a vaccine made from the closely related vaccinia virus.
After a worldwide effort of organized vaccinations, the World Health
Organization declared, in May 1980, the world free of naturally occurring
smallpox.
The health condition of those who receive the smallpox vaccine must be
assessed before and monitored after vaccination. Before vaccination,
potential recipients of the smallpox vaccine must be screened for
contraindications, which are health conditions or symptoms that preclude
vaccination. After vaccination, the vaccination site is monitored for a
skin lesion, known as a "major reaction" or "take," which indicates a
protective immune response. If the vaccination results in a take, a red
itchy bump forms over the vaccination site within 2 to 4 days. Anyone who
does not experience a take has to be revaccinated.
The smallpox vaccination may create side effects known as adverse
reactions. These adverse reactions include temporary symptoms such as
itching, fatigue, muscle ache, and swollen lymph nodes. More serious
adverse reactions include accidental inoculation (localized rash elsewhere
on the body), encephalitis (inflammation of the brain), generalized
vaccinia (rash spread to the entire body), myocarditis or pericarditis
(inflammation in or around the heart), and death. Because the vaccine uses
live virus, an inadvertent transfer of vaccinia can occur in persons
exposed to the vaccination site of someone who has recently received the
vaccine. There are two drugs used to treat certain adverse reactions
caused by the vaccine: vaccinia immune globulin (VIG) and the antiviral
drug cidofovir.
Routine smallpox vaccinations were discontinued among U.S. children in
1972, and among U.S. healthcare workers in 1976. However, in contrast with
the civilian sector, DOD continued to provide smallpox vaccinations to its
troops. Between 1984 and 1990, smallpox vaccinations were only provided
irregularly to recruits during basic training because there were shortages
of VIG.3 In 1990, DOD vaccinations were discontinued until the President
announced the formation of the National Smallpox Vaccination Program in
December 2002.
3In addition, smallpox vaccinations were not provided at some military
facilities because some facilities lacked the ability to test for the
human immunodeficiency virus (HIV), and DOD does not knowingly vaccinate
personnel with HIV.
In administering the civilian component of the National Smallpox
Vaccination Program, CDC updated the Smallpox Response Plan and Guidelines
(CDC guidelines).4 These guidelines include guidelines for recognizing
contraindications and vaccine takes, administering and storing the
vaccine, recognizing adverse reactions, administering VIG, and monitoring
and reporting adverse health events information.
DOD designated the Department of the Army as responsible for overseeing
the military component of the National Smallpox Vaccination Program. The
Army's Military Vaccine (MILVAX) Agency was responsible for developing
clinical guidelines for DOD that are consistent with CDC guidelines for
the civilian component of the National Smallpox Vaccination Program. The
U.S. Army Medical Materiel Agency (USAMMA) Distribution Operations Center
(DOC) was responsible for coordinating the distribution of the smallpox
vaccine within DOD.
In September 2002, we reported on DOD's Anthrax Vaccine Immunization
Program. Specifically, we reported on the limited availability of the
vaccine and general dissatisfaction among military personnel with the
completeness and accuracy of the information DOD provided about the
anthrax vaccination program and the anthrax vaccine.5
DOD Implemented Its Smallpox Vaccination Program in Stages and Took Steps
to Prevent and Monitor Adverse Reactions
DOD implemented its current smallpox vaccination program in stages and
took steps to prevent and monitor adverse health events following the
vaccinations. Prior to full implementation of its program in mid-January
2003, DOD conducted a pilot study during which it vaccinated and monitored
the health of military personnel. DOD used CDC's clinical guidelines as a
template throughout its smallpox vaccination program for establishing
priorities for who would be vaccinated and for screening potential
vaccinees for contraindications. DOD also monitored adverse health events
following the vaccinations with information supplied by each of the
services.
DOD's Smallpox Vaccination Pilot Program Preceded Wider Vaccinations
DOD initiated its smallpox vaccination program with a pilot program. In
December 2002, DOD began the smallpox vaccination pilot program by
vaccinating and monitoring healthcare personnel at four sites: Walter Reed
Army Medical Center, Washington, D.C.; Aberdeen Proving Ground, Md.;
Wilford Hall Air Force Medical Center, Lackland Air Force Base, San
Antonio, Tex.; and the National Naval Medical Center, Bethesda, Md.
According to DOD officials, the intent of this pilot program was to
monitor vaccinee take rates and the frequency of adverse health reactions.
4Centers for Disease Control and Prevention, Smallpox Response Plan and
Guidelines, Draft 3.0
(Atlanta, Ga.: Sept. 21, 2002).
5U.S. General Accounting Office, Anthrax Vaccine: GAO's Survey of Guard
and Reserve Pilots and
Aircrew, GAO-02-445 (Washington, D.C.: Sept. 20, 2002).
In monitoring vaccinees in the pilot program, DOD found that 1,017 primary
vaccinees had a take rate of 95.5 percent, and 975 revaccinees-individuals
who had been vaccinated at some point in the past-had a take rate of 95.8
percent.6 Further, DOD surveys of about 530 health care personnel
vaccinated during the pilot program found that they experienced expected
temporary symptoms after vaccination, such as itching, muscle aches, and
headaches. DOD also reported that there was no transmission of vaccinia
from a healthcare worker to a patient among the 1,992 vaccinations DOD
administered.
DOD Began Full Implementation of its Smallpox Vaccination Program in
January 2003
In mid-January 2003, DOD began full implementation of its smallpox
vaccination program. DOD started vaccinating in stages-prioritizing its
personnel according to which groups would respond first to a smallpox
outbreak. Healthcare providers were vaccinated first. To do this, DOD
began Stage 1a of its smallpox vaccination program, which consisted of
vaccinating Smallpox Epidemiological Response Teams who would assist with
epidemic control and contact tracing in an outbreak.7 DOD's smallpox
vaccination program Stage 1b consisted of vaccinating medical teams and
hospital clinic teams who would care for smallpox cases. In Stage 2 of the
smallpox vaccination program, DOD expanded its vaccinations to critical
mission and support personnel-those who were deployed or assigned
overseas, those who would be expected to deploy in a contingency, and
those who support contingency forces when they deploy. (For information on
the number of personnel vaccinated in each stage, see table 1.)
Table 1: Number of Personnel Vaccinated by Service and Stage as of October
8, 2003
Stage 1b Stage 2
Medical and Critical
hospital mission and
Stage 1a Smallpox clinic teams support
Service epidemiological response teams personnel Total
Army 726 4,226 220,917 225,869
Air Force 14 3,644 81,782 85,440
Navy 20 2,053 106,476 108,549
Marines 256 0 64,577 64,833
Coast 669 492
Guarda 16,094 17,255
Total 1,685 10,415 489,846 501,946
Source: Department of the Army.
aThe Coast Guard is an agency within the Department of Homeland Security.
6Primary vaccinees were those receiving the vaccine for the first time.
Revaccinees had been vaccinated at some point in the past. Because
immunity to the smallpox vaccine decreases over time, DOD revaccinated
personnel who had been vaccinated more than 10 years earlier.
7Contact tracing is the identification and tracking of individuals who may
have been exposed to a person with an infectious disease.
Although the stages of the vaccination program were supposed to be
separated, DOD's stages of implementation overlapped because of military
deployment to Iraq in early 2003. As a result, thousands of military
personnel were vaccinated in a short period of time-over 450,000 were
vaccinated as of May 3, 2003-with the number of vaccinations ranging from
300 to 64,000 per week. A DOD official told us that the smallpox
vaccination program is currently in a maintenance phase, with the program
administering approximately 1,000 to 2,000 vaccinations per week to keep
hospital staffs prepared and to prepare new forces supporting U.S. Central
Command.
DOD Followed CDC Guidelines in Screening Potential Vaccinees
In administering these smallpox vaccinations, DOD told us it followed
CDC's guidelines that recommend screening individuals for the
contraindications that preclude smallpox vaccination.8 According to these
guidelines, DOD would not vaccinate personnel with allergies to the
smallpox vaccine, those who were breastfeeding, and those who had certain
cardiac conditions. In addition, DOD would not vaccinate personnel with a
compromised immune system, eczema or atopic dermatitis, active skin
disease such as psoriasis, or those who were pregnant-nor would DOD
vaccinate personnel living with someone who had these four
contraindications.9 DOD implemented this standard because the smallpox
vaccine contains a live virus that can be spread from a vaccinee to a
household member. Officials from the Navy and Marines said they did not
vaccinate personnel living with a child less than 1 year old.
To screen for contraindications, DOD required its personnel to fill out a
form identifying contraindications that may exempt them from receiving the
smallpox vaccine. Completed forms were reviewed by clinicians to resolve
questions about whether specific conditions were contraindications. All
services used the same screening form. DOD officials told us that
contraindications resulted in exemption rates that varied by military
unit, ranging from 11 to 34 percent of eligible personnel. Among service
members in deployed units, living apart from their households, the
exemption rates were lower-ranging from 4.9 to 7.8 percent. Skin
conditions were the primary reason for being exempted from vaccination,
followed by pregnancy and immune conditions.
8According to DOD's policy, in the event of a smallpox outbreak, all
military personnel-including
those with contraindications-would be vaccinated.
9Despite DOD's efforts to avoid vaccinating women who were pregnant, as of
May 28, 2003, 85 women
were vaccinated before they knew they were pregnant. These women were
offered medical
counseling and enrolled in a prospective registry. Similarly, as of May
28, 2003, 10 men were
vaccinated before recognition that they were infected with HIV. They did
not experience any adverse
health reactions at the time they received the vaccine.
DOD Used Two Tracking Systems to Monitor Adverse Health Events
To monitor adverse health events following vaccination, DOD used two
health information tracking systems-one to keep CDC officials apprised of
adverse events following vaccinations and one for DOD officials. CDC
manages, collaboratively with the Food and Drug Administration (FDA), the
first system DOD used, the national VAERS.10 VAERS serves as a national
registry of individual cases of adverse events. Data submitted to this
tracking system can be supplied by patients or clinicians and are
completed on a VAERS form or submitted over the Internet. Although VAERS
forms are typically used to record any adverse events following
vaccinations, in the case of DOD's smallpox vaccinations, DOD officials
said they did not expect clinicians to use VAERS forms to report the
temporary symptoms expected in most smallpox vaccinees such as pustule
formation, itching, or swollen lymph nodes. DOD officials told us that
they decided it was more useful to record noteworthy adverse events on
VAERS forms rather than more common adverse events.11
DOD also used its own internal information system, the DMSS, to track
adverse health events following the vaccinations. DOD officials told us
that military medical units were instructed to file adverse events reports
simultaneously with VAERS and with the medical authority in their
respective service. Each military service was then required to forward
these data to DMSS. The MILVAX Agency reviewed both VAERS and DMSS data. A
DOD official told us DOD used the information in DMSS to determine whether
vaccinated personnel were using more healthcare services than unvaccinated
personnel in order to determine whether the vaccination could be linked to
reported adverse events. This information may also be used to help
identify new, unusual, or rare vaccine reactions; monitor increases in
known adverse reactions; as well as determine patient risk factors for
particular types of adverse reactions.
By October 13, 2003, DOD recorded 184 noteworthy adverse reactions among
the 501,946 vaccinations DOD administered. Of the 184 noteworthy adverse
reactions, DOD reported the following:
o 62 self inoculations (virus affected other parts of body);
o 34 mild cases of generalized vaccinias (blistery body rash);
o 58 acute myopericarditis (swelling of heart tissue or sac around
heart);
o 1 encephalitis (swelling of the brain);
o 1 erythema multiforme major (serious skin reaction); and
o 28 inadvertent transfers of vaccinia.
10VAERS is a national vaccine safety surveillance system that encourages
the reporting of any
significant adverse reaction occurring after the administration of any
vaccine licensed in the United
States. Data reported to VAERS are reviewed by both CDC and FDA. FDA
reviews adverse reactions
reporting trends and assesses whether reported adverse reactions are
adequately reflected in a
product's labeling.
11DOD defined noteworthy adverse events as those that were "significant,
serious, or unexpected and
those that the public and clinicians should know about."
Two of the 184 noteworthy adverse reactions were serious enough to require
treatments with VIG. According to DOD officials, the reported rate of
adverse reactions was similar to or lower than the rates associated with
previous U.S. smallpox vaccination programs, which were conducted in the
1960s. However, some experts have noted that these reported rates may not
be generalizable to the population as a whole because the military
population is relatively young and was carefully screened before receiving
vaccinations.12 DOD officials told us that DOD continues to monitor
adverse health events for which a causal association between the vaccine
and the event has not been confirmed or may be unlikely. For example, DOD
is monitoring the several instances where military personnel have
developed a neurologic reaction that included muscle weakness after
vaccination.
DOD Facilitated Its Smallpox Vaccination Program by Ensuring the
Availability of the Vaccine and by Educating Its Personnel
DOD facilitated its smallpox vaccination program by ensuring the
availability of the vaccine and by educating its personnel. Specifically,
DOD established practices to limit the amount of vaccine that could be
wasted or contaminated. DOD also facilitated its vaccination program by
educating its personnel-both those who administered the vaccine and those
who received it-on the vaccination process. These actions were intended to
help DOD avoid problems it encountered in administering its Anthrax
Vaccine Immunization Program-such as the limited availability and general
dissatisfaction among military personnel with the completeness and
accuracy of the information DOD provided about the Anthrax Vaccination
Program and the anthrax vaccine.13
DOD Took Steps to Ensure the Availability of the Smallpox Vaccine
DOD took steps to ensure the availability of the smallpox vaccine by
limiting the amount of vaccine that could be wasted or contaminated.
Because the smallpox vaccine may lose its potency after 90 days once the
vaccine vial is opened, DOD officials told us that they took steps to
minimize the number of unused doses. For example, to manage requests for
the vaccine and thereby minimize the number of unused doses, each
vaccination clinic was required to submit requests for the number of doses
it needed to the clinic's supporting Service Vaccine Control Center.14
Once the requests were reviewed by the centers, USAMMA authorized shipment
of the smallpox vaccine.15 Similarly, DOD officials said in order to
reduce the possibility of wasting the vaccine supply, USAMMA did not ship
the smallpox vaccine to small units, but brought the units to facilities
where a larger number of personnel were
12M. Wright and A. Fauci, "Smallpox Immunization in the 21st Century,"
Journal of the American
Medical Association, vol. 289, no. 24 (2003).
13GAO-02-445.
14These centers manage and process requests for vaccines and related
supplies for clinical vaccination
sites. The Service Vaccine Control Centers are Naval Medical Logistics
Command
(NAVMEDLOGCOM), Air Force Medical Logistics Office (AFMLO), and USAMMA for
both the Army
and the Coast Guard.
15DOD acquired 1.5 million doses of the smallpox vaccine from CDC's
Strategic National Stockpile.
being vaccinated. Furthermore, units with leftover doses shared their
supplies with other units or with other services to reduce waste. To
ensure the vaccine's potency, its temperature was monitored with a
computer chip to ensure that the vaccine was maintained at the proper
temperature during shipment. This monitoring process was an effort to
avoid DOD's previous experience delivering the anthrax vaccine, when some
vaccine was wasted because the temperature under which the vaccine was
stored could not be confirmed. To ensure that the smallpox vaccine was
delivered without tampering, DOC was to arrange door-to-door, escorted
transportation of the vaccine from the supply depot to the pharmacies and
medical depots supporting the clinics. Upon receipt, shipments of the
vaccine were inspected for damage or signs of contamination.
DOD Facilitated Its Smallpox Vaccination Program with Education Efforts
According to DOD officials, DOD facilitated its vaccination program by
educating those who administered the vaccine and those who received it.
These efforts occurred both before and during the implementation of the
program. A conference in October 2002, before the DOD smallpox vaccination
program was implemented, provided training across all the services. Each
service sent healthcare personnel- approximately 500 in total-to learn the
vaccination procedure. The conference also provided education on vaccine
history and potential adverse reactions, as well as information on the
logistics of receiving and storing the vaccine. The healthcare personnel
who attended were responsible for training other healthcare personnel in
their units. DOD videotaped the conference and required other healthcare
personnel to view various segments of the training relevant to their
responsibilities in administering the smallpox vaccination program.
DOD officials told us that DOD also provided educational support to
potential vaccinees. To ease concerns about receiving the smallpox
vaccine, commanding officers received training materials in advance and
presented information to potential vaccinees before the vaccination
process began. Medical personnel attended these meetings to answer
questions. In addition, questions and answers about the smallpox vaccine
were posted on DOD Web sites. All of the services distributed a trifold
brochure to potential vaccinees that described contraindications, the
appearance of the vaccination site, the expected side effects, and
instructions on how to take care of the skin area where the vaccination
was administered. For additional information, the brochure listed Web site
addresses and contact phone numbers. In some cases, the services required
military personnel to watch a videotape describing the smallpox
vaccination process. DOD organized focus groups between January and March
2003 at selected Army, Navy, Marine Corps, and Air Force facilities to
identify concerns among service members, clinicians, and family members
and gauge the effectiveness of educational materials. Lessons learned from
these sessions were incorporated into subsequent editions of the
educational material. Recommendations from these focus groups included
making information available to all individuals who were going to be
vaccinated or those who would come into contact with them, using layperson
terms, and reinforcing the difference between the smallpox disease and the
smallpox vaccination.
According to DOD officials, these education efforts were key to the
successful implementation of the smallpox vaccination program. DOD
officials explained that these efforts were intended to avoid some of the
problems DOD encountered when it began its Anthrax Vaccine Immunization
Program in March 1998. For example, a survey of Guard and Reserve pilots
and aircrew in 2000 reported dissatisfaction with the completeness and
accuracy of the information DOD provided on the threat posed by anthrax
and on the anthrax vaccine's safety risks and possible side effects.16
Agency Comments
In commenting on a draft of this report, DOD agreed with our findings (see
enclosure). DOD also provided technical comments, which we incorporated as
appropriate.
We are sending copies of this report to the Secretary of Defense and
interested
congressional committees and will make copies available to others upon
request.
This report will also be available at no charge on the GAO Web site at
http://www.gao.gov.
If you or your staff have questions about this report, please contact me
at (202) 512
7119 or Kristi Peterson at (202) 512-7951. Gloria Taylor, Louise Duhamel,
and Krister
Friday made key contributions to this report.
Sincerely yours,
Marjorie E. Kanof
Director, Health CareClinical Health Care Issues
Enclosure
16GAO-02-445.
Enclosure Enclosure
Comments from the Department of Defense
(290275)
*** End of document. ***