This is the accessible text file for GAO report number GAO-04-215R 
entitled 'Smallpox Vaccination: Review of the Implementation of the 
Military Program' which was released on December 01, 2003.

This text file was formatted by the U.S. General Accounting Office 
(GAO) to be accessible to users with visual impairments, as part of a 
longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov.

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately.

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.