Last Updated

30 Nov 2002

Source: Washington Post, February 1, 2002.

FDA Releases Anthrax Vaccine to Military, Approves More

By Justin Gillis, Washington Post Staff Writer

The Food and Drug Administration yesterday released 209,000 doses of a controversial anthrax vaccine to the military and approved a company's plans for making more, decisions that would allow the Pentagon to resume broad inoculation of U.S. troops.

The FDA said the company, BioPort Corp. of Lansing, Mich., had corrected numerous problems found in earlier FDA inspections and could produce a safe, effective vaccine. The agency said the 209,000 doses, made last year, had passed quality-control tests and would be safe to use in U.S. troops.

The decision is certain to renew a debate within the military about the vaccine, which many soldiers have blamed for health problems. Hundreds of soldiers, sailors and airmen have been thrown out of the military for refusing to take the arduous series of six shots, and at least 100 have been court-martialed.

The Defense Department yesterday welcomed the FDA's action and said it would mean a ready supply of vaccine "to protect our troops against the very real threat of anthrax." But the department did not immediately commit to resuming broad vaccinations of U.S. soldiers, saying only that it expects to announce a new vaccination policy "in the near future."

Vaccination of soldiers has been stalled largely because of a critical vaccine shortage caused by BioPort's problems. In the interim the nation had its first bioterrorism scare, involving anthrax -- a dramatic illustration that the germ poses a threat to national security. No one is sure how much skepticism about the vaccine remains among U.S. troops after the events of recent months.

"It's hard to say whether you'll see the same type of opposition in the ranks, because of the change in circumstances," said Mark Zaid, a Washington lawyer who has represented soldiers court-martialed for refusing the vaccine. "I'm sure you will see opposition, but it's unclear how widespread it will be."

In approving BioPort's production facilities and releasing vaccine lots, the FDA toughened the language of its warnings about the vaccine's potential side effects. It emphasized that pregnant women should rarely, if ever, receive the vaccine because an unpublished study suggests that it could heighten the risk of birth defects.

The same anthrax vaccine was recently offered as an experimental therapy to several thousand people in the Washington area, New York, Connecticut, New Jersey and Florida, most of them postal workers, who could have been exposed to anthrax spores during last fall's bioterrorism incidents. Most refused the vaccine, citing concerns similar to those expressed by military personnel.

All the anthrax vaccine stocks BioPort has made to date are owned by the Defense Department. But as the company increases production, BioPort said yesterday, wider use could be possible.

BioPort has no plans to supply the vaccine for broad civilian use, but expects to consult with federal health authorities about whether it should be supplied to groups such as police and firefighters that would be first on the scene of a bioterrorist attack. Some state officials pressed the federal government for vaccine for such workers.

Staff writers Spencer Hsu and Steve Vogel contributed to this report.