GAO

United States General Accounting Office

Report to the Chairman and Ranking 

Minority Member, Committee on 

Veterans’ Affairs, U.S. Senate

October 1999 MEDICAL 

READINESS

DOD Faces Challenges 

in Implementing Its 

Anthrax Vaccine 

Immunization 

Program

GAO/NSIAD-00-36

Page 1 GAO/NSIAD-00-36 Medical Readiness

Contents

Letter 3

Appendixes Appendix I: Scope and Methodology 38

Appendix II: Packaging and Shipping Protocol 41

Appendix III: Survey of Servicemember Views of the Anthrax 

Vaccine Immunization Program 43

Appendix IV: Comments From the Department of Defense 48

Appendix V: GAO Contacts and Staff Acknowledgments 53

Related GAO Products 54

Tables Table 1: Status of 18 Stockpiled Lots Subject to Supplemental

Testing 14

Table 2: Survey on Sources of Anthrax Vaccine Program

Information 30

Table 3: Collection and Review of Electronic and Paper Records 39

Figures Figure 1: Status of Testing for 40 Lots Produced Prior to Shutdown

for Renovations 13

Figure 2: Status of Doses Remaining in Stockpile 15

Figure 3: Comparison of Paper and DEERS Records 21

Figure 4: Respondents’ Assessment of Helpfulness of Information 31

Figure 5: Percentage of Participants Wanting More Information 44

Figure 6: Percentage of Respondents Reporting Short-term Adverse 

Effects, by Service 45

Figure 7: Percentage of Respondents Reporting Adverse Effects

and Wanting Information, by Age Group 46

Figure 8: Percentage of Respondents Reporting Adverse Effects

and Wanting Information, by Race 47
Contents

Page 2 GAO/NSIAD-00-36 Medical Readiness

Abbreviations

CDC Centers for Disease Control and Prevention

CHCS Composite Health Care System

DEERS Defense Enrollment Eligibility Reporting System

DOD Department of Defense

DMDC Defense Manpower Data Center

FDA Food and Drug Administration

GAO General Accounting Office

USAMMA U.S. Army Medical Materiel Agency

VAERS Vaccine Adverse Event Reporting System
Page 3 GAO/NSIAD-00-36 Medical Readiness

United States General Accounting Office

Washington, D.C. 20548

National Security and

International Affairs Division

B-283133 Leter

October 22, 1999

The Honorable Arlen Specter

Chairman

The Honorable John D. Rockefeller IV

Ranking Minority Member

Committee on Veterans’ Affairs

United States Senate

The Department of Defense (DOD) regards the biological agent anthrax, an 

infectious disease that is 99-percent lethal if inhaled by unprotected 

humans, as the single greatest biological weapon threat to U.S. military 

forces. To counter this threat, the Secretary of Defense announced in 

December 1997 a plan to immunize all active and reserve military personnel 

with a licensed anthrax vaccine. The Secretary stipulated that 

immunizations would not begin until DOD (1) established a means of 

testing the vaccine over and above tests required by the Food and Drug 

Administration (FDA), (2) developed a system for tracking vaccinations, 

(3) approved operational and communication plans for the vaccination 

program, and (4) had an outside expert review the health and medical 

aspects of the program. In May 1998, the Secretary announced that his 

conditions had been met, and in August 1998, DOD began immunizations, 

giving first priority to personnel deployable to southwest and northeast 

Asia, areas where U.S. forces are considered at high risk of exposure to 

anthrax.

The vaccination program has been the subject of increasing controversy. 

Public debate has centered on whether the vaccine is safe and effective, 

and whether it is prudent to rely on only one vaccine manufacturer. Since 

the Secretary’s announcement, we have reviewed various aspects of the 

program. In April 1999, we testified on research on the vaccine’s safety and 

efficacy, noting the lack of studies on long-term safety and on human 

efficacy testing against inhaled anthrax.1

 In June 1999, we reported on 

DOD’s financial relationship with the sole-source vaccine manufacturer

1

Medical Readiness: Safety and Efficacy of the Anthrax Vaccine (GAO/T-NSIAD-99-148,

Apr. 29, 1999).
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and attributed the manufacturer’s serious cash-flow problems to an overly 

optimistic business plan.2 The following month, we reported that DOD’s 

data on adverse reactions resulting from vaccinations indicated that female 

servicemembers reported such events in greater numbers than male 

servicemembers and that no studies had been done to determine the 

optimum number of doses of the vaccine.3 We also noted that DOD had 

conducted some research on a second-generation anthrax vaccine but 

considered such research an unfunded requirement and that the 

Department of Health and Human Services had recently funded several 

research grants to develop a second-generation vaccine.

Although the policy to vaccinate the entire force has been questioned, our 

review focussed on the implementation of the vaccination program as 

established by DOD. Given the program’s scope, DOD’s poor medical 

record-keeping during the Gulf War, and serious previous shortcomings at 

the vaccine manufacturing facility, you asked us to review DOD’s 

implementation of the vaccination program as it is currently structured. 

Specifically, as you requested, we assessed DOD’s

• ability to maintain an adequate supply of anthrax vaccine for its 

immunization schedule,

• system for recording and tracking servicemembers’ vaccinations,

• efforts to monitor possible adverse reactions to anthrax vaccinations, 

and

• steps to educate servicemembers about the program. 

To assess the vaccine supply, we reviewed the quantity of vaccine in 

stockpile, the status of efforts to test the stockpiled vaccine, and schedules 

for producing new vaccine. To assess DOD’s tracking of servicemembers’ 

vaccinations, we compared electronic and paper records of vaccinations at 

four locations (one per service). To assess tracking of adverse reactions, 

we evaluated DOD’s data on adverse reactions and interviewed medical 

personnel and vaccine recipients. Finally, to assess DOD’s education 

efforts, we surveyed vaccine recipients during our four site visits and 

discussed education efforts with commanders and program officials. A 

detailed discussion of our scope and methodology is in appendix I.

2

Contract Management: Observations on DOD’s Financial Relationship With the Anthrax 

Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

3

Medical Readiness: Issues Concerning the Anthrax Vaccine (GAO/T-NSIAD-99-226, July 21, 

1999).
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Results in Brief As of July 1999, DOD had given about 1 million anthrax vaccinations to 

more than 315,000 servicemembers, but supply problems jeopardize its 

schedule for vaccinating all 2.4 million servicemembers, and DOD lacks a 

contingency plan in the event these problems are not resolved in time. Test 

failures4 and problems in the testing itself have slowed or precluded release 

of 26 of the 40 vaccine lots since testing began in January 1998. In all, only 

14 lots5

 have been released to DOD since January 1998, and most of these 

have already been used. Moreover, the manufacturer has yet to receive 

FDA permission to release lots produced after restarting operations in

May 1999 following a 17-month shutdown for renovations. As a result, DOD 

has fallen behind its original schedule by 5 months, and it risks further 

disruption if more vaccine does not become available by August 2000. 

DOD’s plans for maintaining an adequate supply of vaccine are optimistic, 

given testing problems, and assume that FDA will grant approval of tested 

lots in less time than in the past. Consequently, DOD may not be able to 

augment its stock of usable vaccine as currently planned. The 

manufacturer’s financial problems, which had threatened vaccine supply, 

have been recently mitigated by a renegotiated contract, but financial 

concerns could re-emerge if there are further delays in releasing vaccine. 

Although DOD has considered options, should the vaccine manufacturer 

have further delays in or lose its ability to produce FDA-approved vaccine, 

DOD does not have a formal contingency plan to deal with such 

possibilities.

DOD has a new recording and tracking system for vaccinations that is 

better than the one used during the Gulf War and in Bosnia, but DOD is not 

meeting its requirement to record vaccination data consistently in paper 

records and in its central database. Our comparison of records from DOD’s 

central database and files at three military installations showed that 85 to 

97 percent of paper and electronic records agreed on the number of 

anthrax vaccinations given to servicemembers, but agreement was lower at 

two of those sites—ranging from 17 to 69 percent—for dates and lot 

numbers. Agreement in all categories was much lower at a fourth 

installation, with match rates of 8 to 22 percent, in part because individuals’ 

duty stations had not been updated. This data is vital for (1) scheduling the 

4

Before some of the stockpiled lots can be released, FDA must approve the results of its 

required lab tests. Other stockpiled lots received FDA approval some years ago but must 

now pass supplemental tests before DOD can use them.

5

Each lot includes roughly 200,000 doses.
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FDA-licensed regimen of six vaccinations and boosters and (2) tracking 

who receives vaccinations from a specific lot, should health concerns 

about a lot later emerge. Delays in updating data on individuals’ duty 

stations have impeded DOD’s ability to use its central database to manage 

vaccination schedules and assess unit readiness. Commanders need 

updated duty station information to ensure their personnel receive 

vaccinations on time so that they may be ready for deployment. In addition, 

DOD does not collect data on those refusing vaccination or leaving the 

service to avoid vaccination. This leaves DOD without an important tool to 

gauge the extent of resistance to the program and target training resources 

to provide servicemembers with the information they want.

DOD has used data from the Vaccine Adverse Event Reporting System to 

monitor adverse reactions (or events) to anthrax vaccinations. The system 

relies on medical personnel or servicemembers to provide needed data. 

However, DOD has not systematically informed these personnel on how to 

provide needed data into the system. As a result, DOD may not have data 

on adverse reactions (or events) that is important for monitoring vaccine 

safety. DOD uses the number of data entries into the system to determine 

an adverse reaction rate. However, this data does not provide sufficient 

basis for reporting a reaction rate because the information is inadequate to 

directly link the health condition of a servicemember to the anthrax 

vaccination. Moreover, such events may be underreported. Further, 

preliminary data from DOD surveys of vaccine recipients indicates a 

greater rate of reaction than is indicated by the reporting system, which 

reported 215 adverse events after over 978,000 vaccinations as of July 1999. 

The reaction rates reported by DOD surveys varied (between 21 and 70 

percent), in part due to methodological limitations such as lack of control 

groups or adjustments for factors such as physical activity and age. DOD 

has reported that there is no evidence of a pattern of serious, long-lasting 

adverse reactions.

DOD has employed a high-visibility campaign to educate servicemembers 

about the program and has taken steps to address the controversy 

surrounding the program. In addition, it recently expanded its 

communications efforts by updating the program’s Internet site, opening a 

toll-free anthrax information line, and forming a speakers’ bureau of 

anthrax experts. However, a survey we performed at four military 

installations, though not projectible beyond the 249 respondents, indicated 

that servicemembers want more information about some issues related to 

the program. More than two-thirds of survey respondents reported that the 

information they received on reasons for the program, shot requirements 
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and schedules, and consequences of refusals was at least moderately 

helpful. However, over half said they either received no information on 

possible long-term side effects and procedures for reporting side effects or 

found the information less than moderately helpful. Although many 

respondents wanted more information on long-term side effects, data on 

this topic is limited because no long-term studies have been carried out. 

DOD officials recently discussed conducting additional studies to increase 

their understanding of possible long-term health effects. 

This report includes recommendations to the Secretary of Defense to 

develop plans in the event that the vaccine does not become available as 

currently anticipated, to provide guidance for the consistent reporting of 

adverse events, and to establish data collection measures that allow the 

program to monitor performance and target training and research 

resources.

Background According to the Chairman of the Joint Chiefs of Staff, anthrax is the 

greatest biological weapon threat. DOD considers vaccination one of the 

measures critical to protecting U.S. forces against such weapons. As a 

result, it has begun immunizing all U.S. military personnel—about

2.4 million servicemembers, including all active and reserve—against 

anthrax. The Secretary of the Army is the Executive Agent of the program, 

which is being implemented in three phases to vaccinate the entire force by 

2004.

• Phase 1—begun in 1998 and ongoing: 423,000 members assigned or 

rotating to high-threat areas have begun or will begin vaccinations. 6

• Phase 2—slated to begin in January 2000: early deploying units—about

1 million personnel—begin vaccinations.

• Phase 3—the remaining approximately 1 million personnel begin 

vaccinations.

The regimen for this vaccine is an initial series of three vaccinations at

2-week intervals, followed by a series of three vaccinations at 6-month 

intervals, with annual boosters thereafter.

6

DOD had planned to begin vaccinations in southwest and northeast Asia in the summer of 

1998. However, in March 1998, when hostilities in southwest Asia seemed likely, DOD began 

vaccinating personnel stationed there ahead of schedule.
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Production and Testing of 

Anthrax Vaccine

The anthrax vaccine was licensed in 1970 to protect occupational groups 

such as veterinarians, meat packers, wool workers, and health officials 

who might come into contact with the disease primarily through the skin. 

Its effectiveness against inhalation anthrax in humans has not been proven, 

as it would be unethical to conduct such studies on humans. However, as 

we reported in our April 1999 testimony,7 studies on the efficacy of the 

vaccine in guinea pigs, rabbits, and monkeys support the view that the 

vaccine can protect against exposure to inhaled anthrax in these animals, 

but the correlation of that protection to humans has not been established. 

DOD recently sought to develop an animal model to establish such a 

correlation.

DOD currently procures the anthrax vaccine solely from one private 

manufacturer, BioPort Corporation. Formerly, the facility was known as 

the Biologic Products Division of the Michigan Department of Public 

Health, then the Michigan Biologic Products Institute. The manufacturer is 

the only FDA-licensed anthrax vaccine manufacturer in the United States. 

BioPort produces the vaccine in lots individually numbered for tracking 

purposes. Each lot generally consists of about 20,000 vials containing 10 

doses each. The lots must be tested according to standard FDA protocols 

for purity, potency, sterility, and safety.8

 Successful results are then 

submitted to the FDA for review. If the test results satisfy FDA, it assigns 

each approved lot an expiration date and notifies the manufacturer that the 

lot can be released for use.

This vaccine has a 3-year shelf life, measured by FDA from the date it 

passed the FDA’s potency test. The manufacturer can request a 3-year 

extension of the shelf life by retesting for potency and submitting passing 

results to FDA for approval. FDA also allows retesting of lots that initially 

fail potency tests, provided the reason for the failure is investigated and 

explained and the retested vaccine meets appropriate standards. Once a

7

Medical Readiness (GAO/T-NSIAD-99-148, Apr. 29, 1999).

8

According to the Code of Federal Regulations (21 C.F.R. section 600), purity is the relative 

freedom from extraneous matter in the finished product; potency is the specific ability or 

capacity of a product as indicated by appropriate laboratory tests or adequately controlled 

clinical data; sterility is the freedom from viable contaminating microorganisms; and safety 

is the relative freedom from harmful effects to persons affected, directly or indirectly, by a 

product when prudently administered, taking into consideration the recipient’s condition at 

the time.
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vial of vaccine is labeled for shipment, its expiration date is changed to a 

maximum of 1 year (not to exceed its 3-year shelf life).9

In March 1997, the FDA cited the manufacturer for repeated deviations 

from applicable standards. According to DOD, in January 1998 the 

manufacturer stopped production as part of a previously scheduled 

renovation plan to support the production, testing, and stockpiling of the 

anthrax vaccine. These renovations were largely funded by DOD. When the 

manufacturer suspended production, it still had 40 lots of anthrax vaccine 

stored at its plant. Of these, 31 had already passed all the tests and had 

received FDA approval for release.10 Nine had not yet been tested. DOD 

decided to subject the 31 approved lots to a series of supplemental tests for 

purity, potency, sterility, and safety as a prudent safeguard.11 DOD 

contracted with an independent firm to oversee the supplemental tests, 

which were conducted by BioPort. DOD also decided that the remaining 

nine lots would not need to undergo supplemental testing, as these had 

never been released and would be undergoing FDA-mandated testing for 

the first time. 

BioPort resumed production of vaccine in the renovated facility in May 

1999. As part of its effort to receive FDA approval of its renovations and 

operational changes, BioPort must submit test data to demonstrate that the 

lots produced are consistent with each other and with anthrax vaccine 

previously produced in the old facility. Once these new lots, called 

consistency lots, pass the FDA tests, and once FDA, upon inspecting the 

facility and operations and reviewing the test results, approves the 

renovations and consistency lots, BioPort will be permitted to resume full 

commercial operations—i.e., sell its newly produced vaccine. Without 

9

In April 1999, 59 Marines were notified that they had received vaccine three weeks after its 

expiration date. Both the FDA and the Armed Forces Epidemiological Board determined 

that there was no concern over the safety or effectiveness of the vaccine. Those notified 

were nonetheless given an option of receiving an additional vaccination if they had concerns 

about the vaccine’s efficacy. The Marine Corps followed up with a message reminding 

Marine commanders of the procedures for checking expiration dates on all vials of vaccine. 

Further, refresher training was implemented at the base in question and was strongly 

recommended for other medical units.

10At the start of the program in March 1998, some of these 31 lots contained fewer than 

20,000 vials because of previous commercial sales and military use.

11As we noted in our April 1999 testimony, quality cannot be guaranteed from final tests 

alone, only from a combination of in-process tests, end-product tests, and strict controls of 

the entire manufacturing process.
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FDA’s approval of its renovations and successful completion of tests on 

consistency lots, however, Bioport can produce vaccine but cannot release 

it for use.

Packing and Shipping the 

Vaccine

DOD manages the transport of anthrax vaccine from BioPort to initial 

military recipients. To obtain its goal of zero defects and to maintain 

vaccine accountability, DOD and BioPort designed a packing and shipping 

protocol that maintains the temperature-sensitive vaccine within a 

constant temperature range during transport.12 Most anthrax vaccine is 

shipped via commercial carriers. It is packaged in temperature-monitored 

boxes for domestic shipments and in refrigerated containers for 

international shipments. Appendix II describes the packing and shipping 

protocol.

Recording, Tracking, and 

Reporting Immunizations 

As of July 1999, DOD had given about 1 million anthrax vaccinations to 

over 315,000 servicemembers. To meet the requirement for a system to 

track servicemembers receiving anthrax vaccinations, DOD’s Defense 

Manpower Data Center added anthrax data fields to an existing DOD-wide 

database of personal, service-related, benefits, and residence information. 

This database, the Defense Enrollment Eligibility Reporting System 

(DEERS), now includes fields to record, among other things, the date and 

lot number of each anthrax vaccination given to each servicemember. Also, 

each service developed its own interim database to fully document 

vaccination information at locations where vaccinations are performed and 

to electronically send the information to DEERS, the central repository for 

such information.13 DOD planned to use an upgrade of its Composite 

Health Care System to replace the interim service-specific tracking 

systems. Both the service interim systems and DEERS were designed to be 

used by unit commanders to ensure that their personnel receive their 

vaccinations according to schedule and by the services to report 

vaccination rates in their joint monthly readiness reports.

According to the services’ implementation guidelines, vaccination 

information is to be recorded on two paper forms—the servicemember’s 

12In June 1998, on the basis of temperature testing, BioPort increased the temperature range 

for safe shipment of the vaccine from 2° to 8° Celsius to 1° to 25° Celsius. 

13The Marine Corps uses the Navy’s database.
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medical record and form PHS-731, commonly known as the yellow shot 

record. The medical record is the property of the government, and the 

yellow shot record belongs to the individual. Procedures for yellow shot 

records varied at the installations we visited. For example, at the Air Force 

location, servicemembers were not given their vaccination unless they had 

their yellow shot record, while other locations did not have this 

requirement. Planning guidance issued by the Joint Staff also required the 

Joint Staff Inspector General to review compliance with requirements to 

document anthrax vaccinations. The review includes a random sample of 

medical records for personnel who received vaccinations between March 

and August 1998. The Inspector General’s review was assigned in May 1998, 

and a report is scheduled to be issued later this year, but preliminary 

results were not yet available at the end of our review.

Tracking Adverse Reactions 

to the Vaccine

DOD submits data on adverse events temporally associated with the 

anthrax vaccine to the Vaccine Adverse Event Reporting System (VAERS). 

VAERS is a passive surveillance system, meaning that it alerts FDA and the 

Centers for Disease Control and Prevention of adverse events that may be 

associated with licensed vaccines through information voluntarily reported 

by health care providers, patients, or families. VAERS also serves as a 

warning signal for detection of previously unreported, unusual adverse 

events and/or unexpected increases in reported events. A panel of experts 

commissioned by the program reviews all VAERS reports after they have 

been submitted to FDA to identify any signaling event that would identify 

problems stemming from the anthrax vaccine. As of July 1999, the panel 

had found no pattern of causality stemming from the use of the anthrax 

vaccine.
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Supply Problems 

Jeopardize DOD’s 

Vaccination Schedule

The most critical component of the program, an adequate supply of 

vaccine, is threatened by testing delays and possible loss of production 

capability. Testing problems have already delayed release of stockpiled 

vaccine,14 many lots of which are still unavailable for use. BioPort has also 

fallen behind schedule in submitting to FDA test results on the lots 

produced after it resumed operations in May 1999. If testing problems are 

not resolved soon, or if FDA withholds approval of BioPort’s renovations or 

newly produced lots, DOD will have difficulty in (1) providing phase 1 

vaccinations beyond August 2000 and (2) beginning phase 2, which has 

already been delayed 5 months. BioPort also faces financial problems and 

some security weaknesses that put the supply of vaccine at risk. On the 

positive side, the program has nearly eliminated loss of vaccine in transit to 

the field thanks to a highly successful shipping and packing system. 

However, despite the risks to the vaccine supply, DOD has not prepared a 

formal, written contingency plan for vaccinating servicemembers should a 

steady supply be further delayed or disrupted.

Testing Problems Have 

Delayed Release of Vaccine

As of June 23, 1999, 26 of the 40 stockpiled vaccine lots were still not 

available for use (see fig. 1). Most of these—18 lots—had undergone but 

not passed all the supplemental tests or had to be retested. An additional 

lot needed to pass FDA-mandated tests. Seven other lots passed 

supplemental or FDA tests but had not yet received FDA approval. In all, of 

the original 40 lots, only 14 had been released for use since the program 

began, and 10 of these had been depleted.

14Although the original stockpile contained 31 lots, we use the term “stockpile” to refer to all 

anthrax vaccine—40 lots in all—stored at BioPort before production restarted in May 1999.
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Figure 1: Status of Testing for 40 Lots Produced Prior to Shutdown for Renovations

When supplemental testing began in January 1998, program officials 

expected to receive the first positive results by April of that year. However, 

problems with testing processes, failure of vaccines to pass tests, and 

limited testing resources delayed or precluded the release of 18 lots. All 18 

lots have passed safety tests but have at least one unresolved issue with 

purity, potency, or sterility.

• Nine lots failed purity tests because the amount of preservative used in 

the vaccine did not meet FDA standards.15 DOD is considering 

permanently removing these lots from the stockpile, given the time and 

resources it would take to resolve the issue.

15BioPort has discussed with FDA completing studies that would enable the manufacturer to 

request FDA approval of release of those lots with less preservative (phemerol) than 

currently required. If these studies show that lower amounts of the preservative are 

effective, and if FDA, after reviewing the data, approves lowering the standard, DOD may be 

able to use some or all of these nine lots.

Needs to pass FDA tests (1 lot)

• Released and available (4 lots)

• Passed tests and awaiting FDA

approval (7 lots)

• Released and depleted (10 lots)

•

Needs retesting (18 lots)

DOD data as of June 23, 1999
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• Three lots initially failed sterility tests, then passed them, but FDA cited 

serious concerns about the lots. According to program officials, the lots 

will probably not be retested and will likely be withdrawn from the 

stockpile.

• Fourteen lots still need to pass potency tests. For two of these, test 

results were invalid due to problems in the test procedures, causing 

BioPort to suspend all further potency tests until the problems were 

resolved. At DOD’s request, an outside scientific team reviewed the test 

procedures and recommended several corrective measures.16 BioPort 

adopted the team’s recommendations, which took several months to 

implement. In all, most potency testing was delayed 6 to 9 months. The 

remaining 12 lots have undergone valid testing but have not passed it.

Table 1 summarizes the tests needed for the 18 lots that have not yet passed 

supplemental testing.

Table 1: Status of 18 Stockpiled Lots Subject to Supplemental Testing

Source: DOD.

Although testing is performed by lots, vaccination schedules are predicated 

on the number of doses available. To understand the implications of these 

testing problems for DOD’s vaccination program, therefore, it is necessary 

to assess available doses—especially because the number of doses in a lot 

varies. As of June 23, 1999, 5.6 million doses remained in the stockpile at 

BioPort, but 4.9 million (88 percent) of these were unavailable for use (see 

fig. 2).

16The team suspected but could not confirm that at least some of the variances were due to 

changes in (1) the size, age, and sex of the test subjects (guinea pigs); (2) a saline solution 

used in the tests; and (3) the strain of anthrax used in the control group.

Supplemental tests needed Number of lots

Potency 6

Potency and sterility 3

Potency and purity 5

Purity 4

Total 18
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Figure 2: Status of Doses Remaining in Stockpile 

Note: Does not include almost 2 million doses that have been released and shipped to installations.

• More than 3 million doses cannot be released unless BioPort retests its 

lots, achieves successful results, and receives FDA approval to release 

them. According to program officials, lots containing a total of over

2.2 million of these doses are not likely to be ever retested due to the 

aforementioned purity and sterility test results.

• More than 1.4 million doses unavailable to DOD are awaiting FDA 

approval of successful testing, and program officials expected to 

successfully test and request FDA approval for an additional almost 

206,000 doses needing FDA tests before October 1999. 

In summary, as of June 23, 1999, only 713,000 doses in the stockpile were 

available for use, and more than half of them—about 416,000 doses—will 

expire in February and April 2000. On the basis of DOD’s estimates of doses 

required per month, the 713,000 doses would sustain phase 1 of the 

program through December 1999. This estimate does not include doses 

Number of doses

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

Available for use

Awaiting FDA approval

Needs FDA tests

Needs retesting

DOD data as of June 23, 1999

713,340

1,405,900

205,910

3,307,080
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already delivered to the field and not yet administered. However, typically, 

no more than a 3-month supply of vaccine is delivered to a location, which 

means that the program could be sustained at best through March 2000, on 

the basis of both delivered and available stockpiled vaccine doses.

Program officials are not concerned about the status of the stockpiled 

vaccine. At the time of our review, they expected FDA to grant release of 

stockpiled lots containing a total of 1.6 million doses before October 1999, 

and they projected this would sustain the program through August 2000. 

This expectation assumes a quick and positive response by FDA. Program 

officials also expected to retest and submit some other lots in early 2000. 

However, this expectation seems optimistic. According to these same 

officials, BioPort’s limited testing resources, overburdened by competing 

demands, are now being concentrated on obtaining FDA approval of 

renovations. Consequently, performing more supplemental tests is a far 

lower priority for both BioPort and DOD.

BioPort Renovations Are 

Behind Schedule and Have 

Delayed the Program’s 

Second Phase

A 5-month delay in completing renovations caused BioPort to delay 

production startup from January 1999 to May 1999. This delay, coupled 

with testing problems and workload, have in turn delayed production and 

approval of vaccine consistency lots. Indeed, BioPort has not yet 

performed FDA-mandated testing on any of the consistency lots, and as a 

consequence, no test results have been submitted to FDA for approval.

In late July, program officials expected BioPort to submit successful results 

for the first consistency lots by September 1999 and expected FDA to 

approve renovations, which involves an inspection of the facility, and 

permit release of these lots by January 2000. This would allow the program 

to begin its second phase 5 months after its scheduled August 1999 starting 

date. Although BioPort officials say they are coordinating more closely 

with FDA now, this expectation seems optimistic. FDA is required to 

review and provide a response to the manufacturer regarding test results 

within 4 to 6 months, but approval is not automatic. Our analysis of past 

test approval periods for potency tests of stockpiled lots,17 showed that the 

time from successful test completion to FDA approval has averaged 10 

months. This period, which includes any delays between test completion 

17The period measured was from the date the manufacturer completed lot potency tests to 

the date FDA approved the results of those tests. BioPort needs approval of potency test 

results as well as approval of its renovations which are separate FDA approval processes.
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and the manufacturer’s submission to FDA, ranged from 2 to 29 months and 

lasted more than 8 months for almost half of the lots analyzed. Should FDA 

question the test results or raise other production issues, release of new 

production could be delayed beyond January 2000. Indeed, FDA concurs 

that this date for approval of renovations and release of lots is optimistic. 

BioPort’s Finances and 

Physical Security Could 

Threaten Vaccine Supply

Although somewhat mitigated by recent contract renegotiations, BioPort’s 

financial problems have reduced the program’s vaccine supply in the short 

term and may threaten future supplies altogether if production does not 

resume. BioPort must improve its financial health if DOD is to retain this 

sole source of anthrax vaccine. In June 199918 we testified about several 

problems at BioPort: (1) renovation delays reduced expected revenues, 

causing a serious cash-flow problem; (2) the company lacked the cash 

reserves and the ability to obtain commercial financing at reasonable rates 

to cover operating expenses; (3) its accounting system was inadequate; and 

(4) the company projected a significant operating loss for the year ending 

December 1999. As a short-term measure to generate revenues to improve 

its financial health, BioPort received authorization from DOD to sell 70,000 

doses of anthrax vaccine to other customers,19 even though it was not fully 

meeting its contractual delivery requirements at the time. This action 

diminished the potential supply available to U.S. forces. Moreover, on the 

basis of renegotiation of its contract with DOD, BioPort (1) will provide 

DOD with fewer doses of the vaccine than its original contract stipulated to 

better reflect its production capabilities and (2) will be permitted to 

increase its private sales to increase revenues. DOD officials stated that 

this reduced availability will still meet the program’s needs. 

Although not as pressing as its financial problems, the physical security of 

BioPort’s facility presents some risk to the vaccine supply. In 1998, the 

Defense Special Weapons Agency reviewed security at what was then the 

Michigan Biologics Products Institute and recommended numerous 

physical and operational measures to correct weaknesses. BioPort 

implemented many of these, including improvements of doors, locks, and 

fences, but rejected other measures it considered “beyond the scope of a 

18Contract Management (GAO/T-NSIAD-99-214, June 30, 1999).

19BioPort sells these doses at a significantly higher price than the DOD contract price. DOD 

has approved the sale of 30,000 doses to the Canadian Armed Forces, and BioPort intends to 

sell the remaining 40,000 doses to other potential customers. These sales would also require 

approval under export control regulations.
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biotechnology business.” These included such measures as increasing 

surveillance and modifying existing structures. According to BioPort, if 

DOD considers further security measures important, it must also consider 

funding them. In the opinion of DOD’s program officials, most of the 

remaining security recommendations are relatively minor in nature and of 

less concern than BioPort’s production problems. DOD is determining the 

most effective means of addressing and funding any high-cost security 

measures at BioPort. At the time of our review, however, DOD did not have 

plans to implement these measures. Absent a specific implementation plan, 

it is unclear when or if these security weaknesses would be addressed.

Well Designed and 

Administered Packing and 

Shipping Eliminate Vaccine 

Losses in Transit

DOD and BioPort have worked closely together to solve the challenges of 

shipping the temperature-sensitive anthrax vaccine to all sorts of climates 

in all types of weather. Although a transport problem in the first shipment 

of vaccine (to a U.S. base in Germany) led DOD to destroy 20,000 vials 

rather than risk distributing vaccine that had been subjected to belowstandard temperatures, the program has had extremely few losses since. 

Learning from this incident, program officials and the manufacturer 

developed a packaging protocol that maintains a safe temperature range 

that is continuously monitored from within the container. They also 

devised a shipping system that uses commercial carriers and constantly 

tracks packages in transit. Shipments are kept small to limit loss from 

misplacement or deliberate destruction. According to the program’s data, 

99.8 percent of all shipped vials arrived safely after the new procedures 

were implemented.20 Given this excellent record, DOD is adapting the 

program’s shipping protocol for other environmentally sensitive 

pharmaceuticals that it manages.

DOD Lacks Contingency 

Plans for Disruption or Loss 

of Production

Program officials acknowledge that BioPort has had testing, production, 

financial, and security problems, but they have developed no formal 

contingency plans to ensure that vaccinations continue if the supply of 

vaccine is disrupted or lost. These officials believe that enough stockpiled 

lots have been released to maintain phase 1 through August 2000. However, 

implementation of phase 2, which depends on new production and release 

of vaccine, has already been postponed by 5 months to January 2000, and 

20This excludes the first shipment of 20,000 vials (464 vials destroyed of 197,487 shipped as 

of July 2, 1999). Including that first shipment, the program’s total success rate is still

90.6 percent of shipped vials and 99.2 percent of all shipments.
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even this new date may be unrealistic. If the testing and other problems 

continue to delay vaccine production and release, DOD will find it difficult 

to provide vaccinations in the latter part of 2000 and beyond.

Program officials have considered how to adjust for limited delays in 

releases of the current supply, but they have no formal back-up plans in 

case of major delays in release of new lots. Several alternatives to the 

current phase 1 schedule may be possible, should BioPort be seriously 

delayed in obtaining FDA approval of its renovations. These alternatives 

range from redistributing vials already sent to the field to suspending all 

further vaccinations except for forces in the highest-risk theaters. 

However, program officials could not provide formal criteria for 

implementing various alternatives, nor could they cite measures of 

potential advantages such as how long a specific alternative might extend 

the program or how many personnel it might maintain.

The program also has no contingency plan should BioPort lose its 

production capability outright, either through FDA rejection of its 

renovations, financial failure, or destruction by natural catastrophe or 

hostile agent. Program officials did consider construction of new and 

completely redundant production facilities, but this alternative was seen as 

too costly and time-consuming. As we noted in an earlier report, 

development of a second-generation vaccine that may provide other 

manufacturing alternatives has begun, but DOD research in the area 

remains unfunded.21 The Department of Health and Human Services 

recently funded several research grants in the area. However, licensing a 

new facility or developing a second-generation vaccine would take several 

years—too long to offset any major loss of production by BioPort during 

the program’s timeline. At present, DOD has no means of continuing 

immunizations with anything other than what is available from the BioPort 

stockpile, most of which still needs to pass tests before it can be used.

21Medical Readiness (GAO/T-NSIAD-99-226, July 21, 1999).
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Recording and 

Tracking Vaccinations 

Has Improved, but 

Further Improvements 

Possible

DOD is more capable of recording and tracking vaccinations today than it 

was during the Gulf War in 1991 or the Bosnia operations in 1995. However, 

DOD is not meeting its requirement to consistently record vaccination data 

in its centralized database and paper records. Such inconsistencies could 

cause vaccinations to be given off schedule or hinder subsequent 

investigations should questions arise about a specific vaccine lot. Also, 

delays in updating data on servicemembers’ duty stations, as well as 

shortcomings in how the services update the DEERS database, have 

limited the utility of the database for determining individual vaccination 

schedules and assessing unit readiness. While DOD tracks vaccination 

exemptions (including waivers and deferrals) for medical reasons such as 

pregnancy or administrative leave, it does not monitor refusals or voluntary 

departures from the service that may be due to vaccine-related concerns. 

As a result, DOD is not able to use the information to monitor all aspects of 

the program’s implementation.

Vaccinations Recorded, but 

Some Data Is Incomplete

The Gulf War and the concerns it subsequently generated about Gulf War 

illnesses highlighted shortcomings in DOD’s systems for recording and 

tracking medical data, including vaccination records. In 1997, we reported 

that DOD had improved its medical surveillance during operations in 

Bosnia but that documentation of vaccinations was one area still needing 

improvement.22

In following up on this deficiency, we found that DOD has improved its 

ability to record and centrally collect vaccination information. Our 

comparison of DEERS data and paper medical records at four military 

installations23 (one per service) indicated that, except at the Marine Corps 

installation, the numbers of vaccinations were recorded consistently. 

22Defense Health Care: Medical Surveillance Improved Since Gulf War, but Mixed Results in 

Bosnia (GAO/NSIAD-97-136, May 13, 1997). Our comparison of a centralized list of vaccine 

recipients with their medical records in five units revealed that vaccinations had not been 

recorded in 24 percent of medical records. Three of the five units failed to record 

vaccinations in more than 30 percent of medical records. 

23We visited one location per service where a large number (more than 1,000) of 

vaccinations had been given: Fort Stewart in Hinesville, Georgia, for the Army; the USS 

Eisenhower, Norfolk Navy Shipyard, Portsmouth, Virginia, for the Navy; Langley Air Force 

Base, Hampton, Virginia, for the Air Force; and Camp Lejuene, Jacksonville, North Carolina, 

for the Marine Corps. Our sample of records cannot be generalized. See appendix I for more 

information on our scope and methodology.
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However, agreement between the two systems was not as high when 

matching specific dates of vaccinations and vaccination lot numbers. 

Inconsistency in dates could lead to vaccinations being given off-schedule 

and to inaccurate readiness reports. Inconsistent or missing lot information 

could hinder investigations, should concerns arise about a specific lot. 

Also, information that is not recorded in paper records makes it difficult to 

address adverse reactions needing immediate care or determine the 

validity of subsequent claims for disability compensation. Figure 3 

summarizes the agreement between electronic and paper information on 

vaccinations by service.

Figure 3: Comparison of Paper and DEERS Records

Source: GAO.

In percent

0

10

20

30

40

50

60

70

80

90

100

Army (200

medical records)

Navy (238

medical records)

Air Force (143

yellow shot

records)

Marines (134

medical records)

85

72

17

97 97 96

92

66 69

22

17

8

Number of vaccinations

When vaccinations were received

Lot number of vaccinations
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We made the following observations:

• The Army base’s low match rate for lot numbers was due to the fact that 

lot numbers were not recorded in the medical records for about

60 percent of vaccinations. Despite this omission, the base did record lot 

numbers in DEERS, and only 1 percent of vaccinations recorded in 

DEERS were without lot numbers.

• The fact that almost all ship personnel received vaccinations on the 

same days while deployed at sea contributed to the high match rate 

between DEERS and medical records on the Navy vessel.

• As shown in figure 3, unlike the other installations we visited, the Air 

Force base relied primarily on the yellow shot record, not the medical 

record, for recording vaccinations on paper. Less than 5 percent of 

vaccinations, dates, or lot numbers in the medical records matched 

information in DEERS. Officials at the site said the yellow shot records 

were smaller and therefore easier to carry on deployment. However, 

unlike the yellow shot record, the medical record is government 

property and should be complete because it serves as evidence for 

determining veterans’ disability compensation. The commander of the 

medical group at the base told us he planned to have the information in 

the electronic records printed and entered in the medical records, but 

this had not been done at the time of our review.

• Marine Corps officials were unable to provide specific reasons for the 

low match rate with DEERS but noted that (1) neither DEERS nor the 

Navy database are optimized to handle the frequent changes in units of 

the Marine Corps−as a result, DEERS did not list all the Marines 

deployed at Camp Lejeune; (2) lack of training on the Navy database−

introduced to the Marine Corps in March 1998, the same month that 

anthrax vaccinations began−could have contributed to inconsistencies; 

and (3) the Navy system uses the date the vaccinations are entered into 

the system as the default, causing inaccuracies if vaccinations are not 

entered into the system the same day they are given.

Services’ Use of DEERS 

Limits Its Utility

DEERS was envisioned as a major source of reports on program 

implementation. However, concerns about the timeliness and accuracy of 

data in DEERS have caused service representatives to rely on interim, 

service-specific tracking systems, and other systems to track and report 

vaccination information. For example, Army and Navy officials said they 

had concerns about DEERS data because duty station information was not 

updated, in some cases for as long as 6 to 9 months, in DEERS.
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Problems we encountered obtaining medical records for our review also 

demonstrated some of the weaknesses in duty station information. For 

example, we found that DEERS did not list all servicemembers assigned to 

a particular duty station. We obtained personnel rosters for Fort Stewart 

and Camp Lejeune from Army and Marine Corps personnel databases. We 

compared a sample 300 records from these two lists with the DEERS roster 

of servicemembers assigned to the two duty stations and found that the 

DEERS database only listed 210 (70 percent) of Fort Stewart personnel and 

111 (37 percent) of Camp Lejeune personnel. 

Army and Air Force officials told us they rely on service-specific tracking 

systems rather than DEERS to obtain more timely information for both 

day-to-day management of vaccinations and quarterly servicewide 

readiness reports. Navy and Marine Corps officials told us that because of 

shortcomings in the Navy tracking system, they rely on reports from 

individual commanders to manage and obtain servicewide data. Officials 

from all four services and the program noted that since the start of the 

program, service-level systems have improved and are more responsive to 

commanders’ reporting needs. 

According to Defense Manpower Data Center (DMDC) officials, delays in 

updating DEERS are caused partly by service personnel systems not 

providing timely data to DEERS. In May 1999, the officials told us they and 

the services had taken steps to update duty station information more 

promptly. We were unable to test the effectiveness of these changes 

because they were instituted after our analysis. DMDC officials also noted 

that some data inconsistencies and delays in resolving errors could have 

been avoided if the services had followed the original design of the tracking 

system, which allows medical providers to be linked directly to DEERS 

through their service-level systems. Such direct linkage (1) ensures that 

servicemembers’ vaccination records are updated regardless of whether 

they are vaccinated by their own or another service and (2) minimizes the 

impact of mistakes (such as entering the wrong social security number or 

recording the same vaccination twice) by providing immediate feedback to 

the user in case of error. However, the Army and Navy have adopted 

systems that do not directly link to DEERS. Instead, Army, Navy, and 

Marine Corps data are transmitted to central servers in their

service-specific systems, which then upload the data to DEERS. This can 

cause delays in correcting errors. DMDC officials reported that the Air 

Force, thanks to its direct linkage to DEERS, receives far fewer error 

messages and has to do fewer follow-ups than the other services. DMDC 
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produces lists of errors each day but has not analyzed how frequently 

different errors occur.

DOD plans to eventually transition the service-specific databases to a 

common system. It has begun testing and in 2000 will install the Composite 

Health Care System II (CHCS-II), which, among other things, is designed to 

interface with DEERS for updating vaccination data. According to DMDC 

officials, the system will ensure consistent data quality across services. 

However, it is unclear when the services will abandon their interim, 

service-specific databases in favor of CHCS-II. Service officials said they 

were reluctant to move to the new system because it will rely on DEERS 

for vaccination and duty station data and will not be under the control of 

the individual services for program upgrades. Moreover, CHCS-II is not 

intended for use by deployed units, so it cannot be used on locations such 

as Navy ships. DOD has established a team with representatives from all 

services that meets regularly to address problems associated with vaccine 

tracking systems.

Goal Performance Measures 

Do Not Include Exemptions 

and Refusals

DOD set a timeliness goal of vaccinating 90 percent of all servicemembers 

no more than 30 days after their vaccinations are due according to the 

licensed regimen.24 As of July 1999, all services (except the Army) had met 

or exceeded that goal. The Army had a 78-percent compliance rate at that 

time. The data used to calculate the percentage of “on-time shots,” 

however, does not include exemptions or refusals.

Servicemembers can receive exemptions from vaccinations for medical 

reasons (e.g., pregnancy) or administrative reasons (e.g., extended leave to 

change duty stations). Exemptions accounted for about 5 percent or less of 

those who received at least one injection, according to service officials. As 

for refusals, the program collected anecdotal data on refusals until January 

1999, but the effort was labor-intensive because it entailed surveying 

individual commanders. Due to the small number of refusals−82 after 

almost 172,000 servicemembers had received one or more injections−

senior Army officials decided the effort was not productive and halted data 

collection. Moreover, reports of refusals did not list personnel who 

24DOD’s policy is to adhere to the approved immunization schedule and to make deviations 

to the schedule the exception rather than the rule. According to DOD policy, the effect of 

deviations from this schedule on the efficacy of the vaccine is unknown, but in general, the 

greater the deviation, the less certain the protective effect in humans.
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voluntarily left the services due to concerns about the vaccine. Although 

the refusal number at the time may have been low, lack of data limits the 

program’s ability to gauge the effectiveness of its education efforts and to 

effectively respond to any increase in opposition to the vaccine. 

According to written guidance from the Army and Navy and our 

discussions with Air Force and Marine Corps officials, servicemembers 

who refuse vaccination are initially provided additional education. 

Servicemembers who continue to refuse are given a direct order, which, if 

disobeyed, can lead to disciplinary action−including discharge−at the 

commander’s discretion. The Air Force, the only service with a database to 

track such information, plans to collect data on disciplinary actions taken 

against those who refuse vaccination, but it has not yet begun to do so. A 

provision in the National Defense Authorization Act for Fiscal Year 2000 

requires an exit survey of all servicemembers leaving military service to 

collect data on, among other things, their reasons for leaving.25 This is also 

a potential source of anthrax refusal data. 

Possible Adverse 

Events Are Monitored, 

but DOD’s Use of Data 

May Be Misleading

DOD monitors possible reactions (or adverse events)26 to anthrax 

vaccinations primarily by using VAERS. However, reports of such events 

may be incomplete because servicemembers have not been fully informed 

about reporting procedures. Moreover, DOD has used the VAERS data to 

report a rate of reaction to the vaccine. This is misleading because of 

potential underreporting of events to VAERS, and the potential for 

overstating the reaction rate because reports sent to VAERS are not 

confirmed to be causally linked to the vaccination. Preliminary data from 

DOD studies of adverse events indicates a higher rate of possible reactions 

than is reported by VAERS, but the reporting rates in these studies varied 

and the studies have methodological limitations. Thus, DOD does not have 

reliable information on the extent of adverse reactions. DOD reported that 

adverse events have been few in relation to the number of vaccinations and 

that there is no evidence of a pattern of serious, long-lasting adverse 

25See section 581 of Public Law 100-65, October 5, 1999.

26Adverse events are adverse outcomes for which a cause and effect relationship with an 

exposure (to a vaccine or a medication) has not yet objectively been determined. An 

adverse event becomes an adverse reaction once objective evidence is available to establish 

a cause-and-effect link between an exposure and an adverse outcome.
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reactions. DOD medical personnel have drafted additional clarifying 

guidance on treating and reporting adverse reactions to the vaccine.

Medical Staff and 

Servicemembers Are Not 

Well Informed About 

Reporting Adverse Events

According to testimony by DOD officials, as of July 1999, 215 adverse 

events27 had been reported to VAERS after about 978,000 vaccinations. 

VAERS is a so-called passive surveillance system, meaning that it relies on 

medical personnel or individuals to report adverse events they think 

resulted from a vaccination. DOD medical personnel are required to file a 

VAERS report for reactions that cause a servicemember either to lose more 

than 24 hours of duty time or to need hospitalization.28 DOD reported, and 

FDA officials commented, that this requirement exceeds FDA 

requirements, which only require vaccine manufacturers, not physicians, to 

report to VAERS, though reporting by physicians is encouraged. 

Nonetheless, VAERS data may be incomplete because DOD medical staff 

and servicemembers have not received the guidance needed to submit 

VAERS reports. Medical officials at a May 1999 conference convened by the 

program to discuss clinical issues expressed concern that they had not 

received clear guidance on how and when to complete VAERS forms. 

According to DOD officials, medical personnel may also report any other 

reaction they think might be caused by the vaccine, but because this is not 

stated explicitly in DOD’s guidance on vaccinations, some medical 

personnel may be unsure about which reactions to report.

Servicemembers and their relatives may also report directly to VAERS any 

adverse events they suspect are related to a vaccine. DOD, however, 

prefers that VAERS reports be filed through its medical providers to ensure 

that data is sufficiently detailed to identify and understand trends. A 

program official acknowledged that anthrax vaccine educational materials 

initially did not explain how to self-report adverse events. Moreover, of the 

249 servicemembers we surveyed,29 44 percent (110) told us they had 

received no information on how to report adverse reactions. 

27Military medical personnel reported 109 of these. 

28Of 174 reports reviewed by DOD, 20 met this criteria.

29As noted in appendix I, respondents were not randomly selected, and thus the data cannot 

be projected beyond those surveyed.
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In April 1999, DOD updated its briefings to include information on 

reporting adverse events. It is also revising regulations to (1) make 

reporting requirements more inclusive, (2) clarify patient and provider 

roles and responsibilities, and (3) explain how to obtain and process 

VAERS forms. In addition, in July 1999, DOD disseminated draft clinical 

guidelines for the management of anthrax vaccine adverse events that 

outlines clinical protocols, pre-treatments, specialty referral processes, 

contraindications, categorization of local and systemic reactions and 

associated treatment algorithms, and directions for reporting to VAERS.

DOD Has Used Adverse 

Event Data Incorrectly 

In presenting reaction rate data, program and DOD officials have shown 

reactions reported to VAERS as a percentage of all vaccinations. They did 

so in several briefings to GAO and congressional staff, in prepared 

testimony, and on the program’s Internet site. However, according to FDA 

guidance, incidents in the VAERS database reflect a temporal, not 

necessarily a causal, relationship with vaccination and thus should not be 

used to calculate the incidence of reactions. DOD’s use of such a 

percentage is an inaccurate representation of the true reaction rate 

because (1) not all adverse events prove to be adverse reactions and

(2) studies have shown that reactions are often underreported in passive 

surveillance systems such as VAERS, though the extent of possible 

underreporting is unknown. As of July 1999, DOD updated its briefing 

information to more accurately describe adverse events reported to VAERS 

simply as a VAERS report rate.

Other Data on Adverse 

Events Varies 

In studies where vaccine recipients were surveyed about their reactions to 

the vaccine, adverse reactions were reported at a much higher rate than 

adverse events reported to VAERS, though these studies have 

methodological limitations. A 1962 study of the vaccine indicated that mild 

local reactions (swelling of up to 5 centimeters) were reported in

30 percent of recipients and moderate local reactions (swelling of greater 

than 5 centimeters) were reported in 4 percent of vaccine recipients.30 DOD 

has conducted several subsequent studies of adverse reactions using active

30As we testified in April 1999, data from this study was based on a different vaccine than the 

one eventually licensed. FDA reported that the method of preparing the licensed product 

was similar but not identical to the vaccine used in the study and that production changes 

for the licensed vaccine were “minor.”
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monitoring, and preliminary results vary. 31 For example, according to DOD 

testimony, 70 percent of respondents in a 1998 survey of 603 medical 

personnel who had received the vaccine reported a local reaction to the 

anthrax vaccine. In another 1997 study, 16 percent (81 respondents) of

508 servicemembers receiving the vaccine reported mild local reactions, 

while 5 percent (25 respondents) had moderate to severe local reactions. 

As we testified in July 1999, data from other DOD studies also indicated 

that women reported a higher rate of adverse reactions than men. These 

studies relied on self-reported data, did not use control groups, and were 

not adjusted for factors such as occupation, physical activity level, and age.

According to our survey, when asked if they had had any side effects due to 

the anthrax vaccine, 45 percent of recipients (111 respondents) reported 

they had,32 and 30 percent (74 respondents) reported swelling at the 

injection site, the most frequently cited symptom. Of those who reported 

reactions, less than 5 percent (5 respondents)33 said they had missed work 

or a planned activity due to the symptoms, and 13 percent (14 respondents) 

sought medical treatment. Further, the percentage of female 

servicemembers who reported side effects was considerably higher than 

that of male servicemembers (64 percent of the 36 women surveyed against 

42 percent of the 210 men surveyed).

On August 24, 1999, the program convened a team of civilian and military 

experts to design a set of studies to assess the long-term safety of the 

anthrax vaccine. Another long-term study is underway to determine 

whether individuals who received multiple vaccines, including anthrax 

vaccine, during their past employment at Fort Detrick, Maryland, have had 

any long-term health effects. A total of 570 study and control volunteers 

have been enrolled in this case-control study that began in 1996.

31In active monitoring, vaccine recipients are contacted to ascertain if there were any 

adverse reactions to the vaccine after vaccine administration. See Medical Readiness

(GAO/T-NSIAD-99-148, Apr. 29, 1999).

32Other reactions cited by the 111 respondents included redness at the injection site

(12 respondents, or 11 percent), nausea (4 respondents, or 4 percent), loss of appetite

(2 respondents, or 2 percent), headaches (6 respondents, or 5 percent),and infections

(3 respondents, or 3 percent). Respondents were not limited to one response.

33The symptoms reported by these five individuals included burning sensations, colds, need 

for more sleep, memory problems, fevers, headaches, nausea, lower blood pressure, viral 

infections, fainting spells, chronic sinus problems never previously experienced, fevers, and 

blood in the stools.
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DOD Has an Extensive 

Education Campaign 

but Has Not 

Systematically 

Monitored the Results 

of Its Efforts

DOD and the services have used a variety of measures to educate 

servicemembers about the program and have taken steps to address 

controversy surrounding the program. However, many respondents to our 

survey indicated that they had not received information on some topics 

related to the program and desired additional information. The program 

recently established a communications division to implement plans to 

address the expressed desire for more information. More effective 

monitoring of servicemembers’ understanding of the program, including 

the number of refusals to take the vaccine, would help DOD redirect 

educational efforts to those areas where additional information is needed.

Many Servicemembers Have 

Received Some Information 

but Want More on

Long-term Side Effects

DOD and the services have made the vaccination program a high priority. 

At the four military installations we visited, the commanders established 

procedures for administering vaccinations and providing information. In 

addition to giving briefings and distributing pamphlets, the commanders 

expected health care professionals and staff to play key roles in providing 

expert advice to servicemembers. Further, after having briefed 

servicemembers about the threat of anthrax, the safety of the vaccine, and 

the requirement for the vaccine, commanders often highlighted the 

importance and safety of the vaccine by being among the first to receive it, 

often in the servicemembers’ presence. As shown in table 2, according to 

our survey of 249 servicemembers (not projectible beyond those surveyed), 

respondents reported that command briefings and medical staff were their 

primary sources of information.
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Table 2: Survey on Sources of Anthrax Vaccine Program Information

Our survey also showed that for many topics, servicemembers found 

information they received at least moderately helpful, but information 

related to long-term side effects and procedures for reporting side effects 

was not as helpful to many respondents. Figure 4 shows how helpful 

respondents found information they received about each topic.

Percentage of respondents reporting the following as their 

primary source of information

Command

briefing Medical staff

Radio, television.

or print media

Other

sources

Percentage reporting

they received no

information on the topic

Reasons for the anthrax vaccine 

program 41 19 11 15 14

Requirement for all servicemembers 

to get the anthrax vaccine 51 10 14 11 13

Vaccination schedule 30 47 2 9 11

Safety of the vaccine and the extent it 

offers protection against anthrax 20 29 9 21 21

Short-term side effects that may 

occur 13 38 6 18 25

Remote possibility of long-term side 

effects 9 23 8 16 44

Procedures for reporting side effects 16 35 1 4 44

Consequences of refusing the 

vaccine 54 3 14 12 16
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Figure 4: Respondents’ Assessment of Helpfulness of Information

Source: GAO.

According to our survey, at least 57 percent of respondents reported that 

the information they received on the reasons for the program, the 

requirement for the vaccine, the consequences of refusing the vaccine, the 

vaccination schedule, the protection the vaccine offers against anthrax, 

and the short-term effects the vaccine may have was moderately or very 

helpful. There were some areas, however, where many servicemembers 

either received no information or desired additional information. Our 

survey showed that only 35 and 47 percent of respondents, respectively, 

said the information they received on the possibility of long-term adverse 

effects and on reporting adverse reactions was at least moderately helpful, 

and 44 percent said they had not received information on the remote 

In percent

0

20

 40

 60

 80

100

Reasons for the program

Requirement to get the vaccine

Vaccination schedule

Safety of the vaccine

Short-term side effects

Possibility of long term side effects

Procedures for reporting side effects

Consequences of refusal

No information on the topic

Information less than moderately helpful

Information at least moderately helpful

10

30

50

70

90
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possibility of long-term side effects. Further, when asked what additional 

information they wanted, 43 percent (106 respondents) reported a desire 

for information on long-term side effects. 

Many of the respondents who said they wanted information on possible 

long-term adverse reactions also reported experiencing some side effects. 

Fifty-nine of the 111 respondents (53 percent) who reported experiencing 

short-term reactions said they wanted information on the possibility of 

long-term adverse effects. Air Force servicemembers represented almost 

70 percent of this group.

The wish for information on possible long-term adverse reactions was also 

highlighted in May 1999, when a commander temporarily halted anthrax 

vaccinations at Dover Air Force Base, Delaware, until he determined that 

servicemembers’ questions on the vaccine’s safety and its possible health 

risks had been satisfactorily addressed. The questions were spurred by a 

magazine article about an unauthorized additive, squalene, alleged to have 

been used in some vaccine lots and about the alleged relationship between 

the vaccine and Gulf War illnesses. Following an initial meeting at which 

servicemembers raised these questions but were unsatisfied with the 

responses, several DOD, Air Force, and Army personnel knowledgeable of 

the program, including the Air Force Surgeon General, provided responses 

in a second set of meetings. These experts reported that independent 

laboratory tests performed on the specific lots cited by the media had failed 

to find squalene. Subsequently, Dover officials resumed anthrax 

vaccinations. Further analysis of all of 13 additional lots also found no 

evidence of squalene.

Concerns similar to those expressed at Dover have been reportedly voiced 

at other installations. A primary reason for dissatisfaction with information 

about long-term side effects appears to be that research has not been done 

to address the topic. According to program officials, such studies have 

recently been discussed but are not yet funded or underway.

Program Recently 

Established a 

Communications Division

The program has recently established a communications division to focus 

on servicemembers’ information needs. The division updated the program’s 

Internet site and established a toll-free information line and a traveling 

speakers’ bureau of experts on anthrax and the vaccine. The 

communications division was also instrumental in updating briefings for 

installation leaders and medical personnel to provide more detailed 

information on the threat of anthrax. DOD expects these briefings to 
B-283133

Page 33 GAO/NSIAD-00-36 Medical Readiness

respond effectively to commanders’ and medical staff’s needs by 

countering misinformation in the media and on the Internet.

The communications division plans to periodically obtain feedback on 

implementation of its plan, which includes surveys carried out by DOD and 

service program staff while on site visits to convey key messages and 

ensure consistency of information. Program staff, including some from the 

communications division, conducted the first survey in July 1999 and plan 

to conduct surveys at seven other sites to be visited by December 31, 1999. 

The surveys will not be projectible but are expected to provide useful 

information on the implementation of the communications plan. In July 

1999, the program submitted a budget proposal for program evaluation and 

research to include an annual evaluation of communications effectiveness 

and clinical issues. The proposal did not include linking vaccine refusals to 

program effectiveness. 

Conclusions DOD’s policy decision to vaccinate the entire force against anthrax has 

presented many challenges. DOD has made progress in implementing the 

anthrax vaccination program, but several challenges remain. As of July 

1999, DOD had administered more than 1 million vaccinations to over 

315,000 servicemembers. DOD has taken steps to ensure that vaccine lots 

are recently tested for purity, potency, sterility, and safety before they are 

released for use. Vaccinations are recorded in a central database (an 

improvement over past record keeping); data on the program’s 

implementation progress is collected; reported adverse events are 

monitored; servicemembers receive information on the program; and the 

manufacturer’s contract has been restructured to help improve its financial 

condition. 

The first challenge, however, is to develop a formal plan for vaccinating 

servicemembers should the anthrax vaccine supply not be available as 

currently anticipated. If BioPort, the sole-source supplier of the vaccine, is 

unable to obtain FDA approval to release stockpiled or newly produced 

vaccine, DOD will not be able to vaccinate the entire force as planned. 

Developing a formal plan would help DOD consider (1) various 

contingencies, including options for altering the three phases of the 

program, should the vaccine supply become limited and (2) strategies to 

mitigate the risk of loss of the sole-source manufacturer, including 

strategies to acquire a second production source or develop a

second-generation vaccine.
B-283133

Page 34 GAO/NSIAD-00-36 Medical Readiness

Second, while DOD has improved its recording and tracking of 

vaccinations, shortcomings remain in documenting vaccinations in paper 

medical records and in establishing a DOD-wide database useful to 

commanders for tracking vaccinations. To ensure that servicemembers 

obtain the health care they need, especially if they experience short- or 

long-term adverse events associated with vaccinations, DOD must keep 

paper and electronic medical records accurate and current. Also, because 

the anthrax immunization regimen requires several vaccinations over a 

short period and annual boosters, it is critical that commanders have timely 

information about servicemembers in their units who are scheduled for 

vaccinations. Because the DOD-wide database, the Defense Enrollment 

Eligibility Reporting System, lacks current data on servicemembers’ duty 

stations, commanders do not find it useful for scheduling individual 

vaccinations or determining the status of vaccinations for their unit as a 

whole. DOD’s plan to incorporate vaccine tracking in an upgrade to its 

Composite Health Care System program will be of limited use to 

commanders if it does not give them some of the capabilities of the servicelevel systems.

Third, measures used to track program implementation omit important 

data needed to assess overall performance such as refusals. Program 

officials, however, have discontinued monitoring refusals, even though 

such data would help monitor possible lack of acceptance of the program. 

Moreover, previous reports of refusals did not include personnel leaving 

the services because of concern about the anthrax vaccine. If collected 

during exit interviews scheduled in 2000, this data could provide another 

indicator of possible resistance to the program. 

Fourth, data on adverse events may be underreported, making it difficult to 

continuously monitor vaccine safety. DOD has updated educational 

material on reporting adverse events, and monitoring the effectiveness of 

efforts to distribute this information to servicemembers would help ensure 

adverse events are consistently reported. 

Fifth, servicemembers clearly want more information on the possibility of 

long-term side effects. Because the vaccination program is a mandatory, 

servicewide program, it is essential that servicemembers be given the 

fullest information possible on these side effects. Although DOD officials 

have recently discussed potential studies on possible long-term side effects 

of the vaccine, none have been designed or funded.
B-283133

Page 35 GAO/NSIAD-00-36 Medical Readiness

Finally, program officials have not systematically monitored their 

education efforts. Informing servicemembers about the risks of anthrax, 

the protection the vaccine affords, and the vaccine’s safety and efficacy is 

critical to the long-term success of the program. While the program has 

provided information on some of these topics and has established a 

communications division dedicated to improving communications with and 

education of servicemembers, monitoring the effectiveness of such efforts 

is important for allocating education resources. Officials plan to obtain 

feedback on their new efforts but have not yet designed and implemented a 

systematic strategy to help assess overall progress in meeting 

communications goals. Further, because data on refusals to receive the 

vaccine is no longer being collected, it is difficult to better target 

educational efforts and address emerging concerns. 

These problems need to be resolved if the program is to succeed in 

vaccinating the entire force against anthrax. 

Recommendations To address the challenges DOD faces in vaccinating its total force against 

anthrax, we recommend that the Secretary of Defense direct the Secretary 

of the Army, as Executive Agent for the anthrax vaccination program, to

• prepare a formal, written plan that addresses strategies to deal with

(1) contingencies for vaccinating servicemembers if the supply of 

anthrax vaccine is not augmented with new production and (2) the risks 

associated with reliance on a single vaccine manufacturer; 

• routinely collect and report, among other program performance 

measures, data on the number of servicemembers refusing to take the 

vaccine; 

• improve DOD guidance and training on how to report adverse events to 

the Vaccine Adverse Event Reporting System and refrain from 

inappropriately using data from the system to report an adverse reaction 

rate; 

• design and conduct a study on possible long-term side effects of the 

anthrax vaccine and develop a communications plan to provide 

servicemembers information on the status of this effort; and 

• continue improvements in educational efforts by regularly surveying 

vaccine recipients and addressing their educational needs. 

In addition, we recommend that the Secretary of Defense direct the 

Defense Manpower Data Center to 
B-283133

Page 36 GAO/NSIAD-00-36 Medical Readiness

• assess the timeliness of personnel duty station data in the Defense 

Enrollment Eligibility Reporting System to determine where time lags 

occur in obtaining data and take or recommend steps to resolve 

untimely submissions, 

• review service requirements for recording and tracking medical data 

and incorporate plans to address these requirements in future upgrades 

of the Composite Health Care System, and

• include the response “to avoid the mandatory anthrax vaccine” (or 

words to that effect) among answers to questions on the reasons for 

resigning from the military in the DOD-wide exit survey to be 

administered in 2000.

Agency Comments In written comments on a draft of this report, DOD generally concurred 

with the report findings and recommendations, emphasized several areas 

of concern, and described recent or proposed actions to implement 

recommendations made in our report. DOD also provided technical 

comments which we incorporated as appropriate.

DOD commented that we did not fully discuss some key aspects and 

successes of the anthrax immunization program. For example, DOD stated 

that it keeps three paper records to ensure that immunizations are 

documented and that no other organization in the world can match this 

accomplishment. Our report recognizes that DOD has made improvements 

to its systems for recording and tracking vaccinations but notes that further 

improvements are needed to ensure that data are recorded in an accurate 

and timely manner. DOD also stated that the report, “did not mention the 

excellent long-term safety record of the vaccine examined over a period of 

44 years.” Our report notes that GAO’s recent work on this issue found that 

data on the vaccine’s long-term safety is limited. In our previous work, we 

found that while some studies have spanned many years, they focus on 

short-term reactions to the vaccine. For example, a 20-year study on 

reactions to the vaccine only reported on symptoms that began within 48 

hours of the vaccination. Moreover, DOD has indicated that additional data 

on the vaccine’s long-term safety would be beneficial and has established a 

committee to identify and plan additional research on this issue.

Finally, DOD noted several actions it has taken or plans to take to 

implement our recommendations such as using existing data to develop a 

written plan to address possible vaccine shortages and improving DOD 

guidance and training on how to report adverse events to the Vaccine 

Adverse Event Reporting System. Regarding our recommendation that 
B-283133

Page 37 GAO/NSIAD-00-36 Medical Readiness

DOD use a DOD-wide exit survey to query members whether the 

requirement to receive the vaccine affected their decision to resign, DOD 

noted that it is not appropriate to single out anthrax vaccinations as a 

potential reason for departing the military because it is a “leading” question 

and would produce survey bias. Rather, DOD believes that focus groups 

and surveys of individuals who refuse to take the vaccine are more 

appropriate assessment tools. We believe that DOD should pursue other 

methods, such as focus groups, to determine the possible impact of the 

anthrax vaccine program on retention but believe that a response category 

about the anthrax vaccine could be included on DOD’s exit survey since it 

will be one of many possible reasons for leaving the military. 

We are sending copies of this report to Representative Bob Stump, 

Chairman, and Representative Lane Evans, Ranking Minority Member, 

House Committee on Veterans’ Affairs. We are also sending copies to the 

Honorable William S. Cohen, Secretary of Defense; the Honorable Louis 

Caldera, Secretary of the Army; the Honorable Richard Danzig, Secretary of 

the Navy; the Honorable F. Whitten Peters, Secretary of the Air Force; 

General James L. Jones, Commandant of the Marine Corps and Dr. Jane E. 

Henney, Commissioner of Food and Drugs. Copies will also be made 

available to others upon request. 

Please contact me at (202) 512-3958 if you have any questions concerning 

this report. Key contacts and major contributors to this report are listed in 

appendix V.

Carol R. Schuster

Associate Director, National Security

Preparedness Issues
Page 38 GAO/NSIAD-00-36 Medical Readiness

Appendix I

Scope and Methodology ApendxIi

To conduct our review, we interviewed officials and obtained documents 

from the Army Office of the Surgeon General’s Anthrax Vaccine 

Immunization Program; the Joint Program Office for Biological Defense; 

the Naval Medical Information Management Center; the Offices of the 

Judge Advocates General for the Army, the Navy, Marine Corps, and the Air 

Force; and the Joint Staff. We also obtained information and discussed the 

program with officials from the Defense Manpower Data Center (DMDC) in 

Seaside, California, and Arlington, Virginia; U.S. Air Force Air Combat 

Command, Langley, Virginia; U.S. Navy Space and Warfare Systems 

Command, Chesapeake, Virginia; medical and command personnel at Fort 

Stewart, Georgia; USS Eisenhower, Norfolk Naval Shipyard, Portsmouth, 

Virginia; Langley Air Force Base, Virginia; and Camp Lejeune, Jacksonville, 

North Carolina. In addition, we interviewed officials and obtained 

documents from BioPort Corporation in Lansing, Michigan; and the Food 

and Drug Administration (FDA) in Rockville, Maryland.

To determine the availability of the vaccine and its impact on program 

schedules, we reviewed and summarized data on vaccine lot status, 

including supplemental test results, lot quantities, lot expiration dates, and 

results of initial lot release testing. We analyzed assumptions of projections 

for vaccine production and usage and compared them with program 

schedules and past testing data. We also discussed measures for securing 

and shipping the vaccine with officials from BioPort, the U.S. Army Medical 

Materiel Agency, and one installation at each service.

To assess systems for recording and tracking vaccinations, we selected one 

installation from each service where a large number of vaccinations had 

been given (at least 1,000) and randomly selected 300 service members 

who had received at least one injection of the vaccination series.1

 We then 

compared the information on the paper records with data from the Defense 

Enrollment Eligibility Reporting System (DEERS). Table 3 summarizes the 

installations visited, records reviewed, and time frames of our collection of 

DEERS and paper data.

1

Files for the Fort Stewart location inadvertently included the records for the first 300 social 

security numbers, and therefore were not random.
Appendix I

Scope and Methodology

Page 39 GAO/NSIAD-00-36 Medical Readiness

Table 3: Collection and Review of Electronic and Paper Records

Source: GAO.

We compared the vaccination number, date, and lot number contained in 

the DEERS database with data on paper records—the medical record and 

yellow shot records available on site. A mismatch of any vaccination for 

each category was considered a mismatch for the entire record. Because 

our samples included only those who had received at least one injection, 

our analyses did not examine the possible condition that a servicemember 

received an injection but did not have it recorded in DEERS. Further, 

although our initial sample of records was designed to project our results 

to the installations we visited with a precision of ±5 percent at a 95-percent 

confidence level, operational limitations in the field—most notably the 

unavailability of some records because of deployments and transfers—did 

not allow us to review sufficient records to generalize our results to all 

personnel at the four installations with a reasonable level of confidence.

To evaluate the reporting of vaccine-related adverse events, we reviewed 

FDA requirements for the Vaccine Adverse Event Reporting System 

(VAERS), obtained reports of adverse events from the program, discussed 

reporting procedures with medical and command personnel at the four 

military installations we visited, and reviewed additional Department of 

Defense (DOD) studies on adverse events. In addition, we attended the May 

1999 Annual DOD Conference for Biological Warfare Defense 

Immunizations.

To assess education initiatives of the program, we reviewed guidance and 

service plans to determine education requirements; collected and reviewed 

educational material used at the military installations we visited, discussed 

education efforts with command and medical personnel at each installation 

and with FDA officials, and surveyed a total of 249 servicemembers at 

those installations. We did not evaluate the accuracy of information 

Service location visited

Population that

received at least

one vaccination

Medical

records

reviewed

Yellow shot

records

reviewed

Date DEERS data

was received

Date(s) paper record

data was reviewed

Army: Fort Stewart, GA 8,751 200 197 1 Dec. 1998 14-17 Dec. 1998

Navy: USS Eisenhower, VA 2,108 238 1 2 Feb. 1999 16-17 Feb. 1999

Air Force: Langley AFB, VA 1,273 186 143 9 Nov. 1999 30 Nov. 1998

Marines: Camp Lejeune, NC 1,842 134 4 10 Mar. 1999 15-18 Mar. 1998
Appendix I

Scope and Methodology

Page 40 GAO/NSIAD-00-36 Medical Readiness

provided to vaccine recipients but used the survey to determine what 

information was available to servicemembers and how helpful they found 

the information. Questionnaire respondents were, with three exceptions, 

vaccine recipients who were available at the time of our site visits. Because 

the respondents were not randomly selected, their responses cannot be 

projected. Details of the questionnaire and responses are in appendix III. 

We also discussed program plans for future communications and education 

initiatives with program officials.

We conducted our review from July 1998 through July 1999 in accordance 

with generally accepted government auditing standards.
Page 41 GAO/NSIAD-00-36 Medical Readiness

Appendix II

Packaging and Shipping Protocol ApendxIi

This appendix describes DOD’s packaging and shipping protocol for 

transporting anthrax vaccine from BioPort to military sites. DOD’s packing 

and shipping goals are to have zero defects (such as package damage that 

would ruin the vaccine) and zero loss of accountability (such as packages 

disappearing due to mishandling or theft).

Packaging BioPort packages vials of anthrax vaccine according to the protocol 

designed by DOD and BioPort to maintain doses within an acceptable 

temperature range (1−25°C). The vials are shipped in an insulated 

container along with gelatin cold-packs, a digital monitor that records the 

temperature every 5 minutes throughout transit, an addressed envelope for 

return of the monitor, and an address label for return of the packaging 

materials to BioPort. In tests of the temperature monitor, DOD found its 

failure rate to be just under 1 percentusually due to a mechanical or 

electrical problem. There are several layers in each container:

• The first layer is composed of two gelatin cold-packs. In spring and fall, 

one of the packs is frozen before packing; in summer, both are frozen. In 

winter, neither is frozen.

• The second layer is made of cold-packs that are never frozen before 

shipping. The vaccine vials and the temperature monitor are packed 

between the second and third layers.

• The third layer holds two more cold-packs cooled to 4°C. 

The highest temperature recorded since use of this protocol began (in a 

shipment sent to southwest Asia) has been 16°C.

Shipping DOD’s shipments of anthrax vaccine are managed by the U.S. Army Medical 

Materiel Agency (USAMMA). Shipments in the continental United States, 

nearly all of which are by air, are performed by Federal Express. Some 

overseas shipments are also carried by Federal Express, but most are 

delivered by DHL World Wide Express. Should either Federal Express or 

DHL World Wide Express go on strike, the other carrier would take over 

delivery of shipments.

The shipping label on each box has a code to track the package, giving 

DOD “total asset visibility.” As part of its Priority Alert program, Federal 

Express gives DOD’s shipments priority and aggressively pursues solutions 

to problems that arise. The shipping box carries fluorescent “Priority Alert” 
Appendix II

Packaging and Shipping Protocol

Page 42 GAO/NSIAD-00-36 Medical Readiness

labels on all sides to notify handlers that the box must be moved first and 

never bumped. If a Priority Alert shipment is held up by problems with 

Federal Express’ transportation vehicles, the company immediately 

arranges with a common carrier to move the shipment. Federal Express 

employees take procedural problems uncovered through this program 

directly to the company’s managers for priority resolution.

Federal Express has given USAMMA a computer system to track 

shipments, and pagers are used for the two organizations to maintain

24-hour communication. BioPort enters information on an outgoing 

vaccine shipment into the Federal Express system, establishing instant 

visibility. The program can also generate reports that identify, among other 

things, systemic problems with shipments to a particular military 

installation. USAMMA, thus alerted, can check with the site and clarify the 

situation. Special software, PC Track, will soon link USAMMA to Federal 

Express’ mainframe computer and provide more communication regarding 

shipments.

USAMMA notifies military recipients beforehand of imminent shipments 

and gives instructions to alert local security about the shipment and verify 

that proper refrigeration will be available in the receiving area. USAMMA 

also faxes them a checklist to be used when the shipment arrives. Upon 

receipt, the recipient visually inspects the package for damage. If damaged, 

the recipient is to refuse shipment and contact USAMMA. The military 

recipient then refrigerates the vaccine at 2−8°C in a restricted area and 

returns the monitor to USAMMA. The recipient awaits authorization from 

USAMMA, which checks that temperature data recorded by the monitor 

did not exceed temperature tolerances before releasing the vaccine. If the 

package’s interior temperature has been too high or low at any point in 

transit, it shows up on the monitor’s read-out as a positive or negative spike 

(if the box were opened en route, for example, a positive spike would be 

recorded). Any deviation is recorded on a special form and sent to BioPort 

for assessment.

When a shipping problem occurs, USAMMA conducts a risk analysis that 

runs through an “if/then” protocol. Also, whenever a route is changed, 

USAMMA runs a test shipment of one vial.
Page 43 GAO/NSIAD-00-36 Medical Readiness

Appendix III

Survey of Servicemember Views of the 

Anthrax Vaccine Immunization Program ApendxIi

We surveyed vaccine recipients in all four services about the anthrax 

vaccine program and obtained responses from 249 active duty 

servicemembers: 18 percent (44) in the Army, 12 percent (31) in the Navy, 

34 percent (85) in the Air Force, and 36 percent (89) in the Marine Corps. 

Because our survey participants were not randomly selected, the survey 

results cannot be projected to a larger military population.

• About 89 percent (220) were enlistees and 11 percent (28) officers.1

• 56 percent (140) were between the ages of 18 and 25, the other

44 percent were almost equally distributed between the ages of 26 and 

33 and 34 and 49. Most participants in the Army, the Navy, and the 

Marine Corps were between 18 and 25, while those in the Air Force 

tended to be older. 

• About 86 percent (213) were men. 

• Approximately 65 percent (162) identified themselves as Caucasian,

22 percent (54) as Black, and the remaining 13 percent (32) as either 

Hispanic American, Native American, or Asian American. One 

participant did not respond to the question.

• The number of respondents for each question varied because they were 

instructed to skip questions that did not apply to their individual case. 

Servicemembers 

Wanted Information on 

Possible Long-term 

Effects of the Vaccine 

and Other Issues

Two-thirds (164) of survey participants said they wanted information they 

had not received, including information on temporary or short-term side 

effects of the vaccine, possible long-term side effects, the vaccination 

routine after active duty, the anthrax threat, or other information. 

Participants from all four services also said they wanted information they 

had not received, especially on possible long-term side effects (about

43 percent—106—of all participants). Relative to their peers from the other 

services, a higher proportion of Air Force participants expressed a need for 

information they had not received, particularly on possible long-term side 

effects (see fig. 5).

1 One participant in the survey did not indicate military rank.
Appendix III

Survey of Servicemember Views of the 

Anthrax Vaccine Immunization Program

Page 44 GAO/NSIAD-00-36 Medical Readiness

Figure 5: Percentage of Participants Wanting More Information

Source: GAO.

Examples of topics not listed in the survey about which respondents 

wanted more information included why more than three vaccinations are 

necessary, whether the vaccine has been tested by a qualified source, the 

history of the vaccine, the anthrax disease, and the extent to which the 

vaccine has been used to immunize humans.

Figure 6 shows the percentage of participants, by service, who responded 

that they experienced reactions. The Air Force had the highest rate (68 

percent, or 58 out of 85 respondents).

0

10

20

30

40

50

60

70

80

90

100

Army (n=44) Navy (n=31) Air Force (n=85) Marines (n=89) Total (n=249)

23

32

7

11

30

10

19

7

13

23

40

61

11

21

42

23

38

2

9

22

27

43

6

14

30

Short-term side effects

Long-term side effects

Need for shots after service

Threat

Other
Appendix III

Survey of Servicemember Views of the 

Anthrax Vaccine Immunization Program

Page 45 GAO/NSIAD-00-36 Medical Readiness

Figure 6: Percentage of Respondents Reporting Short-term Adverse Effects, by 

Service

Note: Does not include three respondents who had not received their first shot.

Source: GAO.

Of the 111 survey participants who said they had experienced short-term 

reactions, 57 percent (59) said they wanted information on possible longterm adverse effects.

Figure 7 shows the percentage of participants in three age groups who 

reported having adverse effects and who said they wanted more 

information on possible long-term effects. 

In percent

0

10

20

30

40

50

60

70

80

90

100

Army

(n=43)

Navy

(n=31)

Air

Force

(n=85)

Marines

(n=87)

30

23

68

38
Appendix III

Survey of Servicemember Views of the 

Anthrax Vaccine Immunization Program

Page 46 GAO/NSIAD-00-36 Medical Readiness

Figure 7: Percentage of Respondents Reporting Adverse Effects and Wanting 

Information, by Age Group

a

 Excludes three respondents who had not yet received their first vaccination. The numbers in each 

group are: 18 to 25 years, 138 respondents; 25 to 33 years, 55 respondents; 34 to 49 years, 53 

respondents.

b

 Includes all respondents. The numbers in each group are: 18 to 25 years, 140 respondents; 25 to 33 

years, 56 respondents; 34 to 49 years, 53 respondents.

Source: GAO.

As shown in figure 8, participants in all race categories said they had 

experienced adverse effects and wanted information on possible long-term 

adverse effects. 

In percent

0

10

20

30

40

50

60

70

80

90

100

18-25 years 25-33 years 34-49 years

Age group

38 41

55

48

53

40

Age group reporting side effects

Age group wanting information on long-term side effects

a

b
Appendix III

Survey of Servicemember Views of the 

Anthrax Vaccine Immunization Program

Page 47 GAO/NSIAD-00-36 Medical Readiness

Figure 8: Percentage of Respondents Reporting Adverse Effects and Wanting 

Information, by Race

a

 Does not include one respondent who did not specify race and three who had not received their 

vaccination. The numbers for each group are: Black, 53 respondents; Caucasian, 161 respondents; 

other, 31 respondents.

b

 Does not include one respondent who did not specify race. The numbers for each group are: Black, 

53 respondents; Caucasian, 162 respondents; other, 32 respondents. 

Source: GAO.

In percent

0

10

20

30

40

50

60

70

80

90

100

Black Caucasian Other

Racial group

36

52 50

41 39 38

Racial group reporting side effects

Racial group wanting information on long-term side effects

a

b
Page 48 GAO/NSIAD-00-36 Medical Readiness

Appendix IV

Comments From the Department of Defense ApendxiIV
Appendix IV

Comments From the Department of Defense

Page 49 GAO/NSIAD-00-36 Medical Readiness

Now on p. 35.

Now on p. 35.

Now on p. 35.
Appendix IV

Comments From the Department of Defense

Page 50 GAO/NSIAD-00-36 Medical Readiness
Appendix IV

Comments From the Department of Defense

Page 51 GAO/NSIAD-00-36 Medical Readiness

Now on p. 35.

Now on p. 35.
Appendix IV

Comments From the Department of Defense

Page 52 GAO/NSIAD-00-36 Medical Readiness

Now on p. 36.

Now on p. 36.

Now on p. 36.
Page 53 GAO/NSIAD-00-36 Medical Readiness

Appendix V

GAO Contacts and Staff Acknowledgments ApenxdVi

GAO Contacts Norman J. Rabkin (202) 512-5140

Christine Fossett (202) 512-2956

Acknowledgments In addition to those named above, Margaret Best, Jack Edwards, Julia 

Kennon, Melissa McDowell, MaeWanda Michael-Jackson, and Michael 

Whitlock made key contributions to this report.
Page 54 GAO/NSIAD-00-36 Medical Readiness

Related GAO Products

Medical Readiness: Issues Concerning the Anthrax Vaccine

(GAO/T-NSIAD-99-226, July 21, 1999).

Contract Management: Observations on DOD's Financial Relationship With 

the Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

Combating Terrorism: Observations on Growth in Federal Programs

(GAO/T-NSIAD-99-181, June 9, 1999).

Medical Readiness: Safety and Efficacy of the Anthrax Vaccine

(GAO/T-NSIAD-99-148, Apr. 29, 1999).

Gulf War Illnesses: Questions About the Presence of Squalene Antibodies in 

Veterans Can Be Resolved (GAO/NSIAD-99-5, Mar. 29, 1999).

Combating Terrorism: Observations on Biological Terrorism and Public 

Health Initiatives (GAO/T-NSIAD-99-112, Mar. 16, 1999).

Combating Terrorism: Observations on Federal Spending to Combat 

Terrorism (GAO/T-NSIAD/GGD-99-107, Mar. 11, 1999).

Chemical and Biological Defense: Observations on DOD's Plans To Protect 

U.S. Forces (GAO/T-NSIAD-98-83, Mar. 17, 1998)

Combating Terrorism: Efforts to Protect U. S. Forces in Turkey and the 

Middle East (GAO/T-NSIAD-98-44, Oct. 28, 1997).

Combating Terrorism: Status of DOD Efforts to Protect Its Forces Overseas

(GAO/NSIAD-97-207, July 21, 1997).

Defense Health Care: Medical Surveillance Improved Since Gulf War, But 

Mixed Results in Bosnia (GAO/NSIAD-97-136, May 13, 1997)

(703254) Letr
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