February 1, 2002

Anthrax: FDA Approves Bioport; Company Plans 2 Million Doses for 2002

Global Security Newswire

The pharmaceutical company Bioport yesterday received U.S. permission to resume production of anthrax vaccine (see GSN, Jan. 15).

The Food and Drug Administration said Bioport, the sole U.S. producer of the vaccine, had met all federal requirements and could resume production for the Defense Department. Already, three batches of vaccine containing thousands of doses have passed quality checks and can be distributed immediately, the FDA said.

Bioport plans to produce 2 million doses of the vaccine this year and up to 8 million doses next year, according to Health and Human Services Secretary Tommy Thompson. “This product is a critical component in our arsenal,” Thompson said.

The FDA took “no shortcuts” in approving Bioport to resume vaccine production, even with the “important public health need to move forward on this,” Kathryn Zoon, the FDA official in charge of vaccines, said.

Military Reaction

The Pentagon did not say if or when it would begin mass anthrax inoculations, according to the Associated Press (see GSN, Jan. 18). Vaccinations are to continue for some special missions units, but the department is “undertaking a thorough review of all factors to decide its future use of the vaccine,” officials said (Associated Press/New York Times, Jan. 31).

“We are pleased to learn of the [FDA’s] approval of Bioport’s new manufacturing facility to produce anthrax vaccine,” Assistant Defense Secretary for Health Affairs William Winkenwerder said. “This action by the FDA will result in an assured availability of vaccine, which meets high standards for safety and efficacy, to protect our troops against the very real threat of anthrax” (U.S. Defense Department release, Jan. 31).

Will It be Available for Civilians?

Bioport President Bob Kramer said he is interested in expanding the market for the anthrax vaccine beyond the military.

“It makes sense for these kinds of vaccines to be made available to the public based on their physician’s recommendation in tandem with policy decisions made by public health officials,” Kramer said.

He said Bioport advocates that “first responders” such as police and firefighters receive the vaccine. After that step is completed, a civilian vaccine stockpile “in the case of a more widespread act of terrorism” is important, he added.

The idea of making the anthrax vaccine available to the general public should be seriously considered, said Bradley Perkins, head of the U.S. Centers for Disease Control and Prevention’s meningitis and special pathogens branch.

“At some point, [the Health and Human Services Department] and other people are going to have to entertain — especially if a next-generation vaccine is available — that there may be a market for the vaccine outside of the public health sector,” Perkins said (Sue Ellen Christian, Chicago Tribune, Feb. 1).