Anthrax vaccine OK, FDA says

Published 9:00 pm Tuesday, December 30, 2003

WASHINGTON — The Food and Drug Administration made it official again Tuesday: The anthrax vaccine is safe and effective, no matter how the infection is spread.

The ruling comes a week after a federal judge halted the military’s anthrax inoculations, saying he thought the vaccine was experimental if used to prevent inhaled anthrax instead of the through-the-skin form.

The vaccine actually has been government-approved for sale since 1970 and its label says it protects regardless of the route of anthrax exposure, something FDA officials have repeatedly stressed.

The agency published a formal regulation Tuesday restating the approval — a bureaucratic step decades in the making that doesn’t change the vaccine’s sales status.

It wasn’t clear if the FDA rule would have any effect on suspended military vaccinations.

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