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GAO/T-NSIAD-00-157

MEDICAL READINESS

DOD Continues to Face

Challenges in

Implementing Its Anthrax

Vaccine Immunization

Program

Statement of Carol R. Schuster, Associate Director

National Security Preparedness Issues

National Security and International Affairs Division

Testimony

Before the Committee on Armed Services, U.S. Senate

United States General Accounting Office

GAO
Page 1 GAO/T-NSIAD-00-157

Mr. Chairman and Members of the Committee:

We are pleased to be here today to discuss our past work on the

Department of Defense’s (DOD) anthrax vaccine immunization program.

As you know, 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. DOD

considers vaccination one of the measures critical to protecting U.S.

forces against such weapons. In December 1997, the Secretary of Defense

announced a plan to immunize all active and reserve military personnel

with a licensed anthrax vaccine. In August 1998, DOD began immunizing

all 2.4 million U.S. military personnel—including all active and reserve

personnel—against anthrax.

Today we would like to provide a brief update on three key findings of our

October 1999 report. The findings relate to vaccine supply, medical

records, and efforts to educate servicemembers about the program.1 We

have also reviewed other aspects of the anthrax vaccine immunization

program, including the safety and efficacy of the vaccine and the contracts

with the manufacturer. Our related reports are listed in an attachment to

this statement.

In October 1999, we reported on challenges to implementing DOD’s

anthrax immunization program. First, we noted that supply problems

caused by the manufacturer’s inability to obtain Food and Drug

Administration (FDA) approval to distribute vaccine manufactured at its

renovated facility and problems testing previously stockpiled vaccine

jeopardized DOD’s schedule for vaccinating all 2.4 million

servicemembers. Today, this fundamental requirement of the program—

maintaining an adequate supply of vaccine—has not yet been met. The

manufacturer has not yet obtained FDA approval to distribute vaccine

produced at its renovated facility, and this approval is not expected until

late 2000. Program officials expect the current supply to last until July

2000. Although program officials expect FDA to approve the release of

previously stockpiled vaccine before the available supply is depleted, this

expectation may be optimistic given past testing problems. DOD is

vaccinating only personnel who are being deployed to high-threat areas

and has delayed vaccinations of personnel in units scheduled for early

deployment. If the manufacturer does not obtain FDA approvals as

1 Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization

Program (GAO/NSIAD-00-36, Oct. 22, 1999).

Summary
Page 2 GAO/T-NSIAD-00-157

expected, DOD may be forced to halt vaccinations, at least temporarily.

Moreover, DOD still lacks a contingency plan in the event supply problems

are not resolved in time.

Second, we reported that DOD’s recording and tracking system of

servicemembers who receive vaccinations is an improvement over the

system used during the Gulf War and in Bosnia but that DOD was not

meeting its requirement to record vaccination data consistently both in

paper records and in its central database. DOD reported that it planned to

take further steps to improve its central database. Also, we recommended

that DOD collect data on the number of servicemembers refusing the

vaccine so that it can better understand servicemembers’ concerns. To

date, the Army has drafted a policy to collect data every 3 months. The

other services are not planning to require periodic reporting but will

provide data on vaccine refusals when requested.

Finally, we reported on the results of our survey, which showed that

servicemembers wanted more information on long-term side effects and

procedures for reporting possible side effects from the vaccine. DOD has

taken initiatives to carry out a high-visibility education campaign to inform

servicemembers about the vaccine program. For example, it has

implemented a speakers’ bureau, has updated its Internet site, and is

sponsoring studies of health effects related to the vaccine.

As of March 2000, DOD had administered at least 1.6 million anthrax

vaccinations to about 419,000 servicemembers, but supply problems

jeopardize its schedule for vaccinating all 2.4 million servicemembers.2 As

of April 10, 2000, DOD had approximately 273,000 doses of vaccine tested

and available for use. Assuming the program continues to administer

vaccines at its current rate of about 75,000 doses per month, DOD officials

estimate that the supply will be depleted by July 2000 unless more lots3 of

vaccine are made available. The supply can only be increased if FDA

grants permission for the sole manufacturer to release vaccine produced

2 The vaccination program is scheduled to be implemented in three phases. Phase 1—begun in

1998—includes vaccinations of servicemembers assigned or rotating to high-threat areas. Phase 2—

originally scheduled to begin in January 2000 but not yet begun—includes vaccinations for early

deploying units. Phase 3 includes vaccinations for the remainder of the force. The regimen for the

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.

3 A lot contains approximately 200,000 doses, but at the start of the program some lots contained

fewer doses because of previous commercial sales and military use.

Supply Problems

Jeopardize

Vaccination Program
Page 3 GAO/T-NSIAD-00-157

at its renovated facility or the vaccines stockpiled before the renovation

are successfully tested and released by FDA. There are problems in both

areas.

First, the manufacturer, BioPort Corporation, 4 Lansing, Michigan, has yet

to receive FDA approval of its manufacturing processes following a 17-

month shutdown of the facility for renovation. Until BioPort obtains this

approval and additional approvals for the release of each lot, it cannot

release lots produced after the renovation.5 According to a DOD

contractor’s assessment of a November 1999 FDA inspection report, the

FDA identified 30 deficiencies, largely dealing with BioPort not fully

complying with FDA Good Manufacturing Practice regulations. The

assessment noted that there may be at least two significant issues BioPort

must address, namely implementing a program to validate vaccine

manufacturing and testing processes and systems to ensure product

quality. DOD has taken several initiatives to support and oversee BioPort’s

efforts to obtain FDA approval. According to a contracting official, DOD

intends to order BioPort to stop production of the vaccine and focus

efforts on measures to validate the manufacturing process. DOD also plans

to assist BioPort by funding consultants to help BioPort obtain FDA

approval and to keep the facility operating at a low level. DOD officials

estimate BioPort will not obtain FDA approval of its manufacturing

processes until late 2000. BioPort’s inability to obtain FDA approval of its

anthrax production processes has led to serious cash flow problems.

Further delays will only exacerbate these problems.

Second, unless the currently available 273,000 doses are augmented with

additional approved vaccine from the stockpile, the program will be

without vaccine from July through late 2000 (or whenever BioPort obtains

FDA approval) if it continues administering vaccinations at its current

rate. When the manufacturer suspended production in January 1998 to

undertake renovations, it still had 40 lots of anthrax vaccine stockpiled at

its plant. Of these, 31 had passed all the tests and had received FDA

approval for release. To ensure that no changes had taken place in the

approved vaccine since FDA granted approval, DOD decided to subject the

31 approved lots to a series of supplemental tests for purity, potency,

sterility, and safety. Since supplemental testing began in January 1998, 11

4 In 1998, the facility was sold and the manufacturer’s name was changed from Michigan Biologic

Products Institute to BioPort Corporation. Plans for renovation began under the former name.

5 According to a program official, the lots tested to obtain FDA approval of the new facility’s

manufacturing processes will also be tested for release and should therefore be immediately

available. FDA will have to approve future lots produced after the renovation individually.
Page 4 GAO/T-NSIAD-00-157

of the 31 lots have been made available for use; but 20 lots are still

unavailable due to test failures or problems with the tests themselves. For

example, some vaccine lots did not contain sufficient levels of a required

preservative (test failure), while testing of other lots may have been

invalidated because underweight guinea pigs were used as test subjects

(test problems). For the remaining nine lots produced just before the

renovation shutdown, BioPort needed only to obtain the normal FDA

approval for release. As of April 10, 2000, five of these nine lots had been

approved for release. In sum, only 16 of the 40 vaccine lots in the stockpile

have been released, and according to program officials, almost all have

already been used by the program.

Program officials plan to conduct tests on and obtain FDA approval for

release of a limited number of stockpiled lots, thus augmenting the

currently available doses before they are depleted. They estimate that this

will provide sufficient vaccine to continue the program until FDA grants

permission to release lots produced after BioPort’s renovation, possibly by

late 2000. Our analysis shows that DOD’s time frames for testing and

gaining FDA approval of these stockpiled lots may be optimistic. For

example, it assumes that FDA will expedite approval of a revised testing

protocol and final test results and that BioPort will not encounter testing

problems as it has in the past.

Because of the limited vaccine supply, DOD is vaccinating only personnel

who have deployed to high-threat areas and has delayed vaccinations of

personnel in units scheduled for early deployment. The original date to

begin vaccinating this latter population was January 2000. In response to

our recommendation, DOD drafted a contingency plan to ensure the

continued, measured implementation of the program, but the Office of the

Secretary of Defense has not yet approved this plan.
Page 5 GAO/T-NSIAD-00-157

In October 1999, we reported that DOD’s recording and tracking system

for the anthrax vaccination program is an improvement over the system

used during the Gulf War and in Bosnia. However, DOD was not meeting

its requirement to record vaccination data consistently both in paper

records maintained at its installations and in electronic records in its

central database. We compared servicemembers’ vaccination records from

DOD’s central database with paper records at four military installations.6

At three sites, we found that between 85 and 97 percent of paper and

electronic records agreed on the number of anthrax vaccinations that had

been administered. At two sites, however, matches were lower (between

17 and 69 percent) for the date of the vaccination and the vaccine’s lot

number. Matches in all categories were much lower at the fourth

installation, with match rates of 22 percent for the number of vaccinations,

17 percent for the vaccination date, and 8 percent for the lot number.

These problems were caused in part by delays in updating data on

information in the central database. For example, delays in updating data

on individuals’ duty stations 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 that their

personnel receive vaccinations on time and are ready for deployment. An

accurate centralized database is also important for tracking which vaccine

lots are administered, should health concerns about a specific lot emerge.

In its response to our report, DOD said it would take aggressive steps to

ensure the timely and accurate updating of personnel data in the database.

In addition, at the time of our review, DOD had not collected data on

personnel who refused vaccination or left the service to avoid

vaccination. DOD thus did not have an important tool to gauge the

extent of resistance to the program and target training resources to

give servicemembers needed and wanted information. In its

response to our report, DOD said that it was reviewing a draft policy

memorandum on reporting servicemembers’ refusals to be

vaccinated. In April 2000, a program official told us that this policy

will apply only to the Army and will require major commands to

provide quarterly reports on soldiers who refuse the vaccine. The

other services are not planning to require periodic reporting but will

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

been given: Fort Stewart, 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.

Recording and

Tracking of

Vaccinations Have

Improved, but Further

Improvements Are

Possible
Page 6 GAO/T-NSIAD-00-157

provide data on vaccine refusals when requested. According to the

program official, a servicemember is considered to have refused the

vaccine only after he or she initially declines the vaccine, receives

education and counseling (either verbally or in writing), and then

disobeys a direct order to take the vaccine.

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, our survey of 249

servicemembers at the four military installations between December 1998

and March 1999 indicated that many of them wanted more information on

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

information they received on the reasons for the program, vaccination

requirements and schedules, and consequences of refusing the vaccination

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 longterm side effects, data on this topic is limited because no long-term studies

have been carried out.

At the time of our survey, DOD had not monitored the effectiveness of its

educational campaign. But after our survey, DOD initiated several steps to

improve its educational campaign. It established a communications

division to focus on servicemembers’ information needs. The division

updated the program’s Internet site and set up a toll-free information line

and a traveling speakers’ bureau of experts on anthrax and the vaccine.

DOD has also begun monitoring its educational efforts. Specifically, the

program now surveys servicemembers who have begun or are scheduled

to begin the series of anthrax vaccinations. The survey collects

information on the availability, timeliness, and effectiveness of the

program’s educational materials.

In its comments to our October report, DOD stated that it had taken

several actions to improve guidance and training on reporting adverse

events associated with the vaccine.7 These actions included updating or

developing briefings and fact sheets required to be given to

7 Adverse events are 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.

DOD Has an

Extensive Education

Campaign and Has

Begun to Monitor Its

Effectiveness
Page 7 GAO/T-NSIAD-00-157

servicemembers and clinicians and providing links to adverse event

reporting forms through DOD’s anthrax vaccine Internet site. We have not

assessed these actions or evaluated their impact on the reporting of

adverse health events.

To address questions regarding the safety of the anthrax vaccine, DOD

established a Longitudinal Studies Concept Committee to define research

needs and identify subsequent research designs. The Committee, which

includes members from DOD, FDA, the Centers for Disease Control and

Prevention, and the Armed Forces Epidemiological Board, met in August

and September 1999 and recommended some research designs. One of the

studies being planned is a prospective study of servicemembers that will

follow the health effects over multiple years of vaccine and non-vaccine

recipients. This study is scheduled to begin in 2001.

Mr. Chairman and Members of the Committee, this concludes our formal

statement. We would be happy to answer any questions you may have.

For future contacts regarding this testimony, please contact Carol

Schuster at (202) 512-5140. Individuals making key contributions to this

testimony included Christine Fossett, Margaret Best, and Howard

Deshong.

Contact and

Acknowledgments
Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax

Vaccine Immunization Program (GAO/NSIAD-00-36, Oct. 22, 1999).

Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48, Oct. 12,

1999).

Medical Readiness: Issues Concerning the Anthrax Vaccine (GAO/TNSIAD-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).

Medical Readiness: Safety and Efficacy of the Anthrax Vaccine (GAO/TNSIAD-99-148, Apr. 29, 1999).

Chemical and Biological Defense: Observations on DOD’s Plans To Protect

U.S. Forces (GAO/T-NSIAD-98-83, Mar. 17, 1998).

Defense Health Care: Medical Surveillance Improved Since Gulf War, But

Mixed Results in Bosnia (GAO/NSIAD-97-136, May 13, 1997).

Chemical and Biological Defense: Emphasis Remains Insufficient to

Resolve Continuing Problems (GAO/NSIAD-96-103, Mar. 29, 1996).

Chemical and Biological Defense: Emphasis Remains Insufficient to

Resolve Continuing Problems (GAO/T-NSIAD-96-123, Mar. 12, 1996).

(702065)

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