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Vaccine Maker Gets FDA Approval For Shipments, With Proviso.(Brief Article)
2002 FEB 6 - (NewsRx.com & NewsRx.net) -- The nation's sole maker of the anthrax vaccine says that it has met federal production requirements at its laboratory and is on the verge of resuming shipments to the Pentagon.
BioPort Corp. said a December 27, 2001, letter from the U.S. Food and Drug Administration clears it to begin shipping the vaccine, provided a separate laboratory in Washington state that puts the vaccine into vials also gets FDA approval.
The vaccine itself also must be tested by BioPort for purity, potency and sterility and be released by the FDA. Pressure to get the labs approved has grown since U.S. troops began heading overseas in the war on terrorism and since last fall's anthrax outbreak killed five people on the East Coast.
The vaccine has been licensed by the FDA since the 1970s. BioPort bought its lab from the state in 1998 but has been unable to sell the vaccine because the building failed two FDA inspections after a renovation. The company has spent nearly four years trying to meet FDA requirements.
In its letter, the FDA said the company has made or is in the process of making the seven production-related changes requested by inspectors during a visit last month.
At Hollister-Stier Laboratories in Spokane, Washington, where the vaccine manufactured by BioPort ...
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