FDA Extends Authorization for Anthrax Vaccinations

The U.S. Food and Drug Administration will allow voluntary vaccinations of military personnel to continue at least until early 2006, FDA Commissioner Lester Crawford stated Friday (see GSN, July 7).

The agency’s emergency use authorization for Anthrax Vaccine Adsorbed is to be maintained for the duration of the Defense Department’s emergency declaration, Crawford wrote in a letter to Assistant Defense Secretary William Winkenwerder Jr. The declaration is scheduled to expire on Jan. 14, 2006.

Winkenwerder requested the extension on July 11 “for such time as necessary pending the upcoming FDA re-determination of the licenses use of AVA for protection against inhalational anthrax.”

The agency to date has certified the vaccine as effective only for use against anthrax infection contracted through skin contact. The voluntary program began after a federal judge ruled last year that the Pentagon could not require military and civilian personnel to be vaccinated (U.S. Food and Drug Commissioner Lester Crawford letter, July 22).

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