Smallpox Vaccination:

Review of the Implementation of the Military Program

GAO-04-215R: Published: Dec 1, 2003. Publicly Released: Dec 1, 2003.

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On December 13, 2002, in response to growing concern that a terrorist or hostile regime might have access to the smallpox virus and attempt to use it against the American people, the President announced the formation of the National Smallpox Vaccination Program. The program has two components--one responsible for vaccinating civilians and another responsible for vaccinating military personnel. The Centers for Disease Control and Prevention (CDC) is responsible for implementing the civilian component of the National Smallpox Vaccination Program. The Department of Defense (DOD) is responsible for implementing the military component of the program. Because the National Smallpox Vaccination Program is the nation's first large-scale bioterrorism defense program, Congress asked us to assess the implementation of the program in order to aid the development of future programs. In April 2003, we reported on the implementation of the civilian component of the National Smallpox Vaccination Program. In this report, we describe (1) how DOD implemented its smallpox vaccination program and (2) the steps DOD took to facilitate the implementation of the program.

DOD implemented its smallpox vaccination program in stages and took steps to prevent and monitor adverse health events following the vaccinations. The first stage of the smallpox vaccination program consisted of a pilot program that began in December 2002, during which DOD vaccinated and monitored the health of military personnel at four sites. According to DOD officials, the intent of the pilot program was to assess DOD's procedures for administering the vaccine and monitor the frequency of adverse health reactions. After completion of the pilot program, DOD began full implementation of the smallpox vaccination program in mid-January 2003. DOD vaccinated its personnel in stages--prioritizing its personnel according to which groups would be most likely to respond first to a smallpox outbreak. As of October 2003, DOD had vaccinated more than 500,000 military personnel. In order to minimize the number of people who might have adverse reactions to the vaccine, DOD followed CDC guidelines by screening personnel for health conditions that precluded them from receiving smallpox vaccinations. To monitor adverse health events following the vaccinations, DOD used two health information tracking systems, CDC's Vaccine Adverse Event Reporting System (VAERS) and DOD's Defense Medical Surveillance System (DMSS). To facilitate its vaccination program, DOD took steps to ensure the availability of the vaccine and educate its personnel. Specifically, DOD established practices to limit the amount of vaccine that could be wasted or contaminated. For example, to ensure the vaccine was not wasted due to a loss of potency, its temperature was monitored with a computer chip to ensure that the vaccine was maintained at the proper temperature during shipment. DOD also facilitated the implementation of its vaccination program by educating its personnel--both those who administered the vaccine and those who received it--on related issues, such as vaccination procedures and potential adverse health reactions.

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