Anthrax vaccine safe, says FDA

updated 6:53 p.m. ET Dec. 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.

The FDA in 1972 gained jurisdiction over vaccines and related products from the National Institutes of Health and began double-checking that they met the agency’s requirements. In 1985, FDA proposed the rule codified today, re-certifying the safety of the anthrax vaccine and some other vaccines against bacterial infections. That proposal had never been finalized as the FDA moved on to jobs it considered more important.

The anthrax attacks of 2001 reminded the FDA that it needed to formally finish the job, and the rule was moving through final review by the Bush administration when the judge ruled last week.

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

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