Medical Readiness:

Safety and Efficacy of the Anthrax Vaccine

T-NSIAD-99-148: Published: Apr 29, 1999. Publicly Released: Apr 29, 1999.

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Pursuant to a congressional request, GAO discussed the results of its ongoing examination of the safety and efficacy of the anthrax vaccine, focusing on: (1) the short- and long-term safety of the vaccine; (2) the efficacy of the vaccine; and (3) problems the Food and Drug Administration (FDA) found in the vaccine production facility in Michigan that could compromise the safety, efficacy, and quality of the vaccine.

GAO noted that: (1) the anthrax vaccine being given to U.S. military personnel was licensed in 1970; (2) before the vaccine was licensed, the vaccine and the manufacturing process were changed, creating a similar vaccine, produced by the Michigan Department of Public Health (MDPH), which was the one eventually licensed; (3) the safety study conducted before licensing used both the original vaccine and MDPH vaccine; (4) knowledge to date about the safety of the vaccine includes the results of the original study and a 1998 Department of Defense (DOD) study of 500 vaccine recipients; (5) while these studies identified varying rates of adverse reactions, they did not question the safety of the vaccine; (6) the long-term safety of the vaccine has not yet been studied; (7) prior to the time of the licensing, no human efficacy testing of the MDPH vaccine was performed; (8) however, a study was done on the efficacy of the original vaccine; (9) this study concluded that the vaccine provided protection to humans against anthrax penetrating the skin; (10) in the 1980s, DOD began testing the efficacy of the licensed vaccine on animals, focusing on its protection against inhalation anthrax; (11) DOD recognizes that correlating the results of animal studies to humans is necessary and told GAO that it is planning research in this area; (12) careful control of the manufacturing process is essential to ensure the quality of the product; (13) FDA inspections of the facility where the licensed vaccine was manufactured uncovered numerous problems; (14) the facility received warning letters from FDA, including one in March 1997, stating its intent to revoke the facility's license; (15) the facility closed its plant in 1998 and is now being renovated; (16) FDA requires the manufacturer to meet specifications for sterility, stability, purity, and potency; and (17) in addition to the lot release testing required by FDA, DOD is conducting supplemental testing of each lot from this plant before distributing the vaccine.

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