Anthrax Vaccine: GAO's Survey of Guard and Reserve Pilots and Aircrew
Highlights
GAO reviewed the views of pilots and aircrew members of the Air National Guard and Air Force Reserve regarding the Anthrax Vaccine Immunization Program (AVIP) of the Department of Defense (DOD). In December 1997, the Secretary of Defense announced a plan to inoculate U.S. forces against the potential battlefield use of anthrax as a biological warfare (BW) agent. In the context of the conventional battlefield, the nature and magnitude of the military BW threat has not changed materially since 1990 in terms of the number of countries suspected of developing BW capability, the types of BW agents they possess, or their ability to weaponize and deliver BW agents. In marked contrast to other mandatory DOD immunization requirements, GAO's sample survey in 2000 showed that AVIP was at that time adversely affecting the retention of trained and experienced guard and reserve pilots and aircrew members. Between September 1998 and September 2000, 16 percent of the pilots and aircrew members of the guard and reserve had (1) transferred to another unit (primarily to nonflying positions to avoid or delay receiving the anthrax shots), (2) moved to inactive status, or (3) left the military. Additionally, one in five of those still participating in or assigned to a unit in 2000 indicated their intention to leave in the near future. At the time of the survey, two-thirds of the guard and reserve pilots and aircrew members did not support DOD's mandatory AVIP or any future immunization programs planned for other BW agents. However, these negative views did not appear to indicate a general antivaccine bias. On the basis of the survey, GAO estimated that 37 percent of the guard and reserve pilots and aircrew members had received one or more anthrax shots as of September 2000. Of these recipients, 85 percent reported experiencing some type of reaction. This overall rate reported for adverse reactions following anthrax immunization was more than double the rate published in the vaccine manufacturer's product insert that was in use at the time of the survey. Respondents to the survey indicated that they had not reported most of the reactions they cited to the military chain of command through official or informal channels and that they were not reported to Food and Drug Administration's Vaccine Adverse Events Reporting System (VAERS). Reasons survey respondents gave for not reporting to the military chain of command included a lack of awareness of VAERS, a concern about the loss of flight status, a possibly adverse effect on military or civilian career, and a fear of ridicule.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Defense | The Secretary of Defense should direct the establishment of an active surveillance program (unlike the passive VAERS) to identify and monitor adverse events associated with each anthrax vaccine immunization. This program should ensure that appropriate and complete treatment and follow-up are provided to those who have experienced adverse events and to those who may experience them in the future. |
In comments on the draft of this report, DOD did not concur with GAO's recommendation to establish a surveillance program. In support of its position, DOD cited the following statement from the Institute of Medicine's report: The Institute of Medicine "committee observes that no data that indicate the need for the continuation of special monitoring programs for anthrax vaccine have emerged, but it recognizes the real concerns for service members ordered to take the vaccines." In addition, DOD stated that data from the Defense Manpower Data Center about actual pilot separations did not support the statements in the report in that the center's data show that pilot separations before the beginning of the anthrax program in 1998 were similar to the rates during the time of the survey. DOD further stated that GAO's report did not address the normal or expected rates of turnover known to occur among personnel in the Air National Guard and the Air Force. DOD's selective use of a conclusion from the Institute of Medicine report that "a separate AVA monitoring program is not necessary" is misleading. This response, while technically correct, ignores the comprehensive recommendations that the institute's report actually made to DOD. Specifically, the institute recommended that DOD (1) use Vaccine Adverse Events Reporting System (VAERS) data to generate hypotheses to study further, using DOD's new unified service medical reporting system; (2) regularly study those data for new trends; (3) work with the Department of Veterans Affairs to encourage participation in the Millennium Cohort study to better get a handle on all the problems associated with the Gulf War and other actions; and (4) regularly do ad hoc unit-based population monitoring of reactions to all vaccines. In addition, the Institute of Medicine report recommended that anthrax vaccine lots produced after renovations at the BioPort vaccine production facility should continue to be monitored for immunogicity and stability and that individuals receiving these lots should be monitored for possible acute or chronic events of immediate or later onset. Adoption of these recommendations would satisfy GAO's recommendation.
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