Medical ReadinessDOD Continues to Face Challenges in Implementing Its Anthrax Vaccine Immunization Program Gao ID: T-NSIAD-00-157 April 13, 2000
Anthrax is an infectious disease that is 99-percent fatal in people who have not been vaccinated. The Defense Department (DOD) has made anthrax vaccination a priority in protecting U.S. troops against biological weapons. In late 1997, DOD announced plans to immunize all 2.4 million U.S. military personnel--both active duty and reserve--with a licensed anthrax vaccine. This testimony updates the key findings of an October 1999 GAO report. (See GAO/NSIAD-00-36.) These findings related to vaccine supply, medical records, and efforts to educate servicemembers about the program. This testimony also reviews other aspects of the anthrax vaccine immunization program, including the safety and the efficacy of the vaccine and the contracts with the manufacturer.
GAO noted that: (1) in October 1999, GAO reported on challenges to implementing DOD's anthrax immunization program; (2) GAO 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; (3) this fundamental requirement of the program--maintaining an adequate supply of the vaccine--has not yet been met; (4) program officials expect the current supply to last until July 2000; (5) 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; (6) 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; (7) if the manufacturer does not obtain FDA approval as expected, DOD may be forced to halt vaccinations, at least temporarily; (8) moreover, DOD still lacks a contingency plan in the event supply problems are not resolved in time; (9) GAO 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; (10) DOD reported that it planned to take further steps to improve its central database; (11) also, GAO recommended that DOD collect data on the number of servicemembers refusing the vaccine so that it can better understand servicemembers' concerns; (12) to date, the Army has drafted a policy to collect data every 3 months; (13) the other services are not planning to require periodic reporting but will provide data on vaccine refusals when requested; (14) the results of GAO's survey showed that servicemembers wanted more information on long-term side effects and procedures for reporting possible side effects from the vaccine; (15) DOD has taken initiatives to carry out a high-visibility education campaign to inform servicemembers about the vaccine program; and (16) for example, DOD has implemented a speakers' bureau, has updated its Internet site, and is sponsoring studies of health effects related to the vaccine.