"Anthrax Vaccine Supplier Sought".

Text of Article:
Pentagon Anthrax Vaccine Program:
Bioport Anthrax Vaccine Supplier:
Additional Anthrax Reference:
Other Links:
Feedback:

By David Briscoe

The Associated Press

WASHINGTON (AP) - A shortage of anthrax vaccine and huge increases in the cost of buying it from a single private source are spurring support for direct government production of anti-bacterial warfare drugs.

A government-owned plant would be operated by a contractor ``to manufacture a variety of vaccines to address the most likely and deadly spectrum of threats to our soldiers, sailors, airmen, Marines and Coast Guardsmen,'' Deputy Defense Secretary Rudy de Leon told a Senate panel Wednesday.

Such a facility would take five to six years to set up, de Leon told a Senate Armed Services Committee hearing. Getting a second commercial source could take from two to four years, and getting approval for vaccine that has already been produced will take several months, he said.

Top Pentagon civilian and military officials will consider government vaccine production at a budget meeting later this month.

Facing a vaccine shortage, the Pentagon has reduced its inoculations against the deadly anthrax by 80 percent after spending close to $100 million to fully protect only a small fraction of the force from the odorless, colorless bacterium the military fears will be used as a weapon by America's enemies. For now, the only shots are for those considered most at risk: soldiers in Korea and the Middle East.

Sen. Tim Hutchinson, R-Ark., said he generally opposes government taking over private enterprise, but government control over vaccine production may be needed since private production has failed.

"We're leaving our men and women in the military vulnerable by scaling back this program,'' Hutchinson said.

Much of the money spent thus far is going to BioPort Corp., a Lansing, Mich., company with 210 employees that has failed to meet Food and Drug Administration requirements and has yet to manufacture a single dose that can be used by the military.

The company tends a dwindling stockpile of the vaccine, and it has produced up to 3 million new doses it hopes to make available when the FDA approves its work, possibly later this year, said spokeswoman Kelly Rossman-McKinney.

The FDA recently refused to clear 800,000 doses of the stockpiled vaccine because of irregularities in potency tests. The company also failed to meet FDA requirements for its refurbished plant. It plans to resubmit its license application by the end of August.

With BioPort running out of funds, the Pentagon agreed last year to amend its original $29.1 million contract, giving it $24.1 million in ``extraordinary contractual relief,'' including an $18.7 million interest-free advance payment for vaccine. The number of doses it must provide was cut in half and the price per dose doubled for the first year and more than quadrupled for the second year.

"Despite all the challenges, we are confident ultimately the FDA will license our facility and we will be back in the business of manufacturing a safe, pure and effective vaccine for the U.S. military,'' said Rossman-McKinney in an interview.

Responding to a possible government takeover of all manufacturing, Rossman-McKinney said the company was prepared to discuss anything that would meet military needs for the vaccine. She said the company now operates without a profit.

Committee Chairman John Warner, R-Va., said it is unlikely another private manufacturer will want to get into the business because it may not be profitable.

The military still plans to inoculate all 2.4 million of its employees worldwide with the full course of six doses and annual boosters of the anthrax vaccine. So far, about 1.8 million doses have been given to some 455,000 men and women. Some soldiers have been disciplined for refusing to take it.

Rep. Christopher Shays, R-Conn., called for immediate suspension of all mandatory anthrax vaccinations and a review of any disciplinary cases stemming from them.

Pentagon anthrax program: http://www.anthrax.osd.mil

BioPort: http://www.bioport.com 

"CDC Says Training Needed for Bioterrorism".

Top of Page - Clinical Freedom Home Page - Freedom of Choice Medical Care - Current Events -