GAO-04-215R Military Smallpox Vaccination Program 

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 

 

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 GAO-04-215R Military Smallpox Vaccination Program

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. 

 

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 GAO-04-215R Military Smallpox Vaccination Program

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. 

 

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 GAO-04-215R Military Smallpox Vaccination Program

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. 

 

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). 
5 GAO-04-215R Military Smallpox Vaccination Program

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

Service 

Stage 1a 

Smallpox 

epidemiological 

response teams 

Stage 1b 

Medical and 

hospital clinic 

teams 

Stage 2 

Critical mission 

and support 

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 Guarda 669 492 16,094 17,255 

Total 1,685 10,415 489,846 501,946 

Source: Department of the Army. 

a

The Coast Guard is an agency within the Department of Homeland Security.

 

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.
6 GAO-04-215R Military Smallpox Vaccination Program

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. 

 

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. 
7 GAO-04-215R Military Smallpox Vaccination Program

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: 

• 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. 

 

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.” 
8 GAO-04-215R Military Smallpox Vaccination Program

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. 
9 GAO-04-215R Military Smallpox Vaccination Program

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. 
10 GAO-04-215R Military Smallpox Vaccination Program

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 CareClinical Health Care Issues 

Enclosure 

 

16GAO-02-445. 
Enclosure Enclosure 

11 GAO-04-215R Military Smallpox Vaccination Program 

Comments from the Department of Defense 

(290275)