CDC Seeks Access to Anthrax Vaccine
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON - Federal health officials are lining up access to the military's anthrax vaccine in case it's needed for a civilian who is allergic to antibiotics and thus needs some other protection after exposure to anthrax.
The vaccine would not be given routinely to civilians. The Centers for Disease Control and Prevention said it could be useful, however, if someone exposed to any of the anthrax-tainted letters circulating the East Coast could not use any of the antibiotics that fend off anthrax.
So the CDC applied to the Food and Drug Administration on Friday seeking permission to use the vaccine experimentally in that special kind of situation.
It's a formality, said CDC Deputy Director David Fleming. CDC filed the paperwork so there would be no bureaucratic delay in getting the FDA to agree to the use "if we encountered a very unusual incident" where it was needed, Fleming said.
"The evidence is that the vaccine alone is not as effective as antibiotics," Fleming said. "But it would be better than no antibiotics, and in the setting we're talking about, where someone has an allergic reaction, it would be the alternative that would be used."
Under the law, FDA has 30 days to respond to such requests. FDA spokeswoman Lenore Gelb refused to say if the agency would evaluate the CDC's request more quickly or even to confirm it had received the request.
But "whenever there's a public health need, we are acting to review it quickly," she said.
BioPort Corp. in Lansing, Mich., is the Pentagon's sole supplier of anthrax vaccines but has been unable to ship any since 1998 because its renovated factory has not met FDA safety standards. The military last December said it had 60,000 doses of previously manufactured vaccine on hand, but has refused to reveal how many are left now.
About 500,000 of the 2.4 million troops and reservists the Pentagon wanted to inoculate have received the vaccine, but the program has basically been put on hold as supplies to vaccinate additional troops have run low.
Bioport sent the FDA hundreds of pages of studies and other documents last Monday in hopes of winning a license to begin shipments. The FDA has up to six months to decide if BioPort should be licensed, although Health and Human Services Secretary Tommy Thompson has indicated a decision may come much faster.
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On the Net: CDC: http://www.cdc.gov/
FDA: http://www.fda.gov/
Pentagon vaccination program: http://www.anthrax.osd.mil/
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