How not to run a bioterror immunization campaign
GAO blasts military’s anthrax effort
Harsh lessons learned from the government’s forced anthrax vaccination campaign in the military include poor communication, driving people out of the service, and massive underreporting of adverse reactions among those immunized, according to a report by the General Accounting Office (GAO).1
Reasons given for not reporting adverse reactions included the possible effect on a military or civilian career, fear of ridicule, and lack of awareness of the Vaccine Adverse Events Reporting System (VAERS).
Echoing concerns already expressed about the fledgling smallpox campaign in health care, the GAO recommended that the Department of Defense (DOD) establish an active surveillance program instead of using the Food and Drug Administration’s VAERS.
Though they were initially underreported, the GAO report reveals that 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. The insert has now been amended.
"For example, an estimated 84% of the personnel who had had anthrax vaccine shots between September 1998 and September 2000 reported having side effects or reactions," the GAO found. "This rate is more than double the level cited in the vaccine product insert."
The DOD considers inhalational anthrax as one of the greatest bioterrorism threats to U.S. military forces. To counter this threat, DOD officially established the mandatory vaccination program in August 1998 to inoculate all 2.4 million service members, including active duty and reserve component personnel, along with some DOD civilian and contractor employees. This major undertaking involved scheduling and administering more than 14 million shots to satisfy the vaccine’s initial dosage requirements of six shots per individual over an 18-month period, followed by an annual booster.
The anthrax vaccine campaign featured high-visibility education efforts that included information about the threat of anthrax and the safety of the vaccine via a web site, a toll-free hotline, and a speakers’ bureau of experts. To assess the effectiveness of the program, the GAO surveyed a random sample of 1,253 people from DOD’s list of Air National Guard and Air Force Reserve personnel. These included pilots, flight engineers, loadmasters, navigators, and crew chiefs.
"Our findings suggest that DOD’s communications efforts were largely unsuccessful in convincing most [respondents] that the anthrax threat was as serious as alleged," the GAO concluded. "Overall, there was a general and pervasive degree of dissatisfaction about the completeness and accuracy of most of the information DOD provided."
Respondents strongly questioned the battlefield effectiveness of the anthrax vaccine, its history and past usage, its short-term and long-term safety risks, and the possible side effects from the vaccine. The program forced some personnel out of the service, as 16% survey respondents cited the required anthrax vaccine as a prime factor in their decision to leave the military or reduce their level of participation.
"The actual losses and expected losses as a result of this program represented some of the most experienced and highly trained individuals in these services and are people not easily replaced," the GAO warned. "It takes time and a great deal of money and other resources to develop trained, experienced pilots and other aircrew members to support the important missions of these reserve components, particularly in light of the current battle against terrorism."
Reference
1. General Accounting Office. Anthrax Vaccine: GAO’s Survey of Guard and Reserve Pilots and Aircrew. GAO-02-445. Washington, DC; 2002.
Harsh lessons learned from the governments forced anthrax vaccination campaign in the military include poor communication, driving people out of the service, and massive underreporting of adverse reactions among those immunized, according to a report by the General Accounting Office (GAO).
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