Smallpox Vaccination
Review of the Implementation of the Military Program Gao ID: GAO-04-215R December 1, 2003On 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.
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.
GAO-04-215R, Smallpox Vaccination: Review of the Implementation of the Military Program
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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.[Footnote 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:
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 events[Footnote 2]
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.
Background:
Smallpox is a contagious disease that is generally spread through
prolonged face-to-face 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.[Footnote 3] In 1990, DOD
vaccinations were discontinued until the President announced the
formation of the National Smallpox Vaccination Program in December
2002.
In administering the civilian component of the National Smallpox
Vaccination Program, CDC updated the Smallpox Response Plan and
Guidelines (CDC guidelines).[Footnote 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.[Footnote 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.
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.[Footnote 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.[Footnote 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:
[See PDF for image]
Source: Department of the Army.
[A] The Coast Guard is an agency within the Department of Homeland
Security.
[End of table]
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.[Footnote 8]
According to these guidelines, DOD would not vaccinate personnel with
allergies to the smallpox vaccine, those who were breast-feeding, 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.[Footnote 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.
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.[Footnote 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.[Footnote 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:
62 self inoculations (virus affected other parts of body);
34 mild cases of generalized vaccinias (blistery body rash);
58 acute myopericarditis (swelling of heart tissue or sac around
heart);
1 encephalitis (swelling of the brain);
1 erythema multiforme major (serious skin reaction); and:
28 inadvertent transfers of vaccinia.
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.[Footnote 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.[Footnote 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.[Footnote 14] Once the requests were reviewed by the centers,
USAMMA authorized shipment of the smallpox vaccine.[Footnote 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 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.[Footnote 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 CareæClinical Health Care Issues:
Signed by Marjorie E. Kanof:
Enclosure:
Comments from the Department of Defense:
REPLY TO ATTENTION of:
DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL 5109 LEESBURG
PIKE FALLS CHURCH VA 22041-3258:
MCIR
14 November 2003:
John P McLaurin iu MEMORANDUM THRU Assistant the Army:
Affairs):
FOR U.S. General Accounting Office, Director, Health Care - Clinical
Health Care Issues, ATTN: Ms. Marjorie E. Kanof, 441 G Street, NW, Room
5104, Washington, DC 20548:
SUBJECT: Reply to U.S. General Accounting Office (GAC) Draft Report
GAO-04-215R, SMALLPOX VACCINATION. Review of the Implementation of the
Military Program:
1. This is the Department of Defense (DoD) response to the GAO draft
report GAO-04-215R, "Smallpox Vaccination: Review of the Implementation
of the Military Program," dated November 4, 2003. We appreciate the
opportunity to comment on your report.
2. We concur with your report and its findings as written.
3. Our point of contact is COL John Grabenstein, Deputy Director for
Clinical Operations, Military Vaccine Agency, (703) 681-5059. COL
Grabenstein served as the primary action officer on behalf of the DoD
for this GAO review.
FOR THE SURGEON GENERAL:
Signed by:
KENNETH L. FARMER, JR., M.D. Major General:
Deputy Surgeon General:
Encl
(290275):
FOOTNOTES
[1] U.S. General Accounting Office, Smallpox Vaccination:
Implementation of the National Program Faces Challenges, GAO-03-578
(Washington, D.C.: Apr. 30, 2003).
[2] In 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."
[3] In 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.
[4] Centers for Disease Control and Prevention, Smallpox Response Plan
and Guidelines, Draft 3.0 (Atlanta, Ga.: Sept. 21, 2002).
[5] U.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).
[6] Primary 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.
[7] Contact tracing is the identification and tracking of individuals
who may have been exposed to a person with an infectious disease.
[8] According to DOD's policy, in the event of a smallpox outbreak, all
military personnel--including those with contraindications--would be
vaccinated.
[9] Despite 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.
[10] VAERS 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.
[11] DOD defined noteworthy adverse events as those that were
"significant, serious, or unexpected and those that the public and
clinicians should know about."
[12] M. Wright and A. Fauci, "Smallpox Immunization in the 21ST
Century," Journal of the American Medical Association, vol. 289, no. 24
(2003).
[13] GAO-02-445.
[14] These 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.
[15] DOD acquired 1.5 million doses of the smallpox vaccine from CDC's
Strategic National Stockpile.
[16] GAO-02-445.
