This study formed the basis for subsequent licensure of a modified vaccine in 1970. According to DOD and other, unclassified sources, we found that in terms of conventional battlefield use, the nature and magnitude of the anthrax threat has been stable since 1990 and has not changed materially in terms of the number of countries suspected of developing a BW capability, the types of biological agents they possess, or their ability to weaponize and deliver such agents. How the Anthrax Program Affected Aircrew Members’ Decisions to Change Military Status

The anthrax program adversely affected the retention of trained and experienced pilots and aircrew members in the guard and reserve. According to our survey, between September 1998 and September 2000, when AVIP was mandatory, about 16 percent of the guard and reserve pilots and aircrew members had transferred to another unit (primarily to nonflying positions), moved to inactive status, or left the military altogether. Although the survey disclosed that the respondents’ basic views regarding AVIP and the anthrax vaccine were quite negative, the survey did not indicate a general antivaccine bias. Respondents Reported More Adverse Events than Expected

According to our survey results, the reported rate and severity of adverse events experienced by personnel who had received the anthrax shots were considerably higher than those published in the vaccine manufacturer’s product insert in use at the time of the survey or reported by DOD. According to our survey, 37 percent of guard and reserve personnel received one or more anthrax vaccine shots. Of these, 84 percent reported side effects or adverse events—a rate more than double that expected or cited in the product insert. Our survey did not include a sufficient number of women to address this issue. We found that most of the reactions were not reported to the military chain of command through official channels (military medical personnel), informal channels (supervisors), or FDA’s VAERS. Some 49 percent cited concern about the loss of flight status, possible adverse effects on their military or civilian careers, and the fear of ridicule as reasons for not discussing vaccination shot reactions with others. Overall, there was a general and pervasive degree of dissatisfaction among guard and reserve pilots and aircrew members about the completeness and accuracy of most of the information DOD provided on the anthrax vaccine and AVIP. Further, at the time of our survey, 18 percent of those still participating indicated their intention to leave in the near future, again citing AVIP as an important factor in that decision. Questionnaire Development

We developed the survey with the assistance of discussion groups made up of pilots and other aircrew members of the Air National Guard and Air Force Reserve. 1. 2. 3. The Vaccine Adverse Event Reporting System (VAERS). Anthrax Vaccine: Preliminary Results of GAO’s Survey of Guard/Reserve Pilots and Aircrew Members.
Why GAO Did This Study

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).

What GAO Found

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.