Safety

FDA rules anthrax vaccine is safe and effective

Emergency Management Alert, January 13, 2004

The Food and Drug Administration (FDA) ruled December 30 that the anthrax vaccine is safe and effective, a week after a federal judge halted the military's anthrax immunizations, the Associated Press reports.

U.S. District Judge Emmet G. Sullivan said he thought the vaccine was experimental if used to prevent inhaled anthrax instead of the through-the-skin form, but the FDA ruling said the vaccine worked no matter how the infection is spread. The Justice Department, citing the FDA order, asked Sullivan to set aside his preliminary ban, except for the six plaintiffs who filed a class action suit against the Defense Department to stop the vaccinations.

As a result, the Defense Department on December 31 placed a $29.7 million order for anthrax vaccine based on the assumption that Sullivan's ban will be reversed. BioPort Corp. of Lansing, MI, won the contract.

The U.S. government approved the vaccine for sale in 1970; the vaccine's label says it protects regardless of the route of anthrax exposure.

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