Anthrax Vaccine: Safety and Efficacy Issues

Pursuant to a congressional request, GAO discussed the results of its ongoing examination of the safety and efficacy of the anthrax vaccine, focusing on the: (1) need for a six-shot regimen and annual booster shots; (2) long- and short-term safety of the vaccine; (3) efficacy of the vaccine; (4) extent to which problems the Food and Drug Administration (FDA) found in the vaccine production facility in Michigan could compromise the safety, efficacy, and quality of the vaccine; and (5) effects of the anthrax vaccine on children, pregnant women or lactating women.