Servicemen Sue US Government Over Anthrax Vaccine Program

Washington, May 2 (Bloomberg) -- Two servicemen are suing the U.S. government over the anthrax vaccine, claiming immunization against the world's deadliest biological agent isn't approved by the U.S. Food and Drug Administration.

A former Air Force major, Sonnie Bates, and Capt. John Buck, both refused to have the shots, which have been administered 500,000 military personnel, according to the lawsuit.

The inoculations are protection against the virus, that the U.S. believes could be produced by North Korea, Iraq and Iran. The government's goal is to inoculate all 2.4 million active and reserve troops by 2006.

``There's never been a lawsuit specifically challenging the FDA's lawful role in the program,'' said Mark Zaid, an attorney for one of the plaintiffs, citing a pending application of the drug's maker, BioPort Corp., for use specifically against inhaled anthrax.

The anthrax vaccine was approved years ago by the FDA for general use, according to Mark Ellengold, deputy director of the Center for Biologics at the agency.

``The dispute arises because the labeling approved says `for prevention of anthrax' and doesn't specify anthrax via skin, inhalation, food or whatever,'' he said.

Since its inception in 1998, the Pentagon's anthrax vaccine program has been cited for management, efficacy and safety flaws, as well as its reliance on a single manufacturer, privately held BioPort of Lansing, Michigan.

The budget proposal for the U.S. Department of Defense this year includes $52 million to stockpile drugs for use in a terrorist attack with biological weapons such as anthrax.

May/02/2001 17:26 ET
(C) Copyright 2001 Bloomberg L.P.