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DoD, FDA Experts Testify on Anthrax Vaccine Safety

By Staff Sgt. Kathleen T. Rhem, USA
American Forces Press Service

WASHINGTON, Oct. 6, 2000 – DoD officials still feel strongly that the Anthrax Vaccine Immunization Program is necessary to protect U.S. forces, but they are examining different ways to acquire needed stocks of the vaccine.

The department has moved toward alternative strategies for vaccine acquisition, said Charles Cragin, deputy assistant secretary of defense for reserve affairs, while testifying before the House Government Reform Committee Oct. 3. We realize that while the current vaccine is the most effective protection available against this lethal weapon, we must continually explore means to improve that protection.

He said the department is working to reduce its reliance on BioPort Corp. as the only source of the vaccine approved by the Food and Drug Administration. We are seeking to identify a second source for manufacturing the anthrax vaccine that can share the product license with BioPort, he said, noting that DoD has received five expressions of interest thus far. The department will analyze the cost, schedule and technical feasibility of each of these.

We admit (that the current) situation, where there is a single source of the anthrax vaccine, is not the most optimal position for the department, said Anna Johnson- Winegar, acting assistant secretary of defense for health affairs.

DoD is also restricting further payments to BioPort to only those items deemed allowable to comply with both good government fiscal practices and congressional direction, Cragin said.

BioPort has been widely criticized for its failure to earn FDA approval to manufacture anthrax vaccine after retooling its plant and vaccine manufacturing process in 1998. Cragin stressed this poses no danger to service members, because vaccine being administered today comes from previously approved batches manufactured by the plants previous owner, the Michigan Department of Public Health.

It is the shortage of this previously approved vaccine that has caused DoD to scale back its vaccination schedule recently, he said.

DoD experts are also working to develop a completely different vaccine that would protect against several biological warfare agents. Cragin said the fiscal 2001 budget provides for research funds, but didnt say when such research might be expected to yield results.

FDA official Mark Elengold explained the recent controversy over the discovery of squalene, a naturally occurring substance that boosts immune response, in certain batches of the anthrax vaccine. Both DoD and the FDA had previously contended there was no squalene in the vaccine, but more recent tests detected minute amounts.

Elengold explained that earlier tests could detect substances in parts per million, but the most recent tests are more sensitive, capable of detecting substances in parts per billion. The FDA found 10 to 20 parts per billion of squalene in lots of the anthrax vaccine that were administered to U.S. service members.

These limits are so small that until we developed this test, the answer would have been none, Elengold said. He said the squalene levels likely occurred naturally because they were about one-millionth the amount that is safely put into certain other vaccines.

The House committee also heard extensive testimony from current and former members of the military who had either had health problems they believe stem from the vaccine or had left the service after refusing to take the vaccine. Marine Maj. Gen. Randall West, senior adviser to the deputy secretary for chemical and biological protection, rebutted this testimony.

When you take a population of half a million people and give them vaccine, some of them are going to go on and get sick, he said. Eventually, all of us are going to die, but that doesnt mean that illness or that death was caused by the anthrax vaccine.

He specifically referred to Kevin Edwards, an Army soldier who had testified earlier in the day. Edwards was diagnosed with Stephens Johnson Syndrome, a disfiguring disease that causes burns and often vision loss, usually associated with an allergic reaction to a medication.

West said experts at Brooke Army Medical Center, Fort Sam Houston, Texas, and Emory University in Atlanta had reviewed Edwards case and determined it was not related to the anthrax vaccine.

Questioned about the case of Air Force Senior Airman Thomas Collosimo, West admitted there are rare reactions to the vaccine and called the May 2000 incident unfortunate. Occasionally, that happens, he said. It happens in very small numbers, and we wish it didnt happen at all.

Collosimo suffered severe reactions to the anthrax vaccine, including blackouts, dizziness and memory loss, and was sent from Hill Air Force Base, Utah, for treatment at Walter Reed Army Medical Center here.

West explained why it isnt feasible for DoD to make the anthrax vaccination program optional for service members. (In the event of an anthrax attack,) it would be very, very difficult to take care of the half of your force that wasnt vaccinated, he said. And, it would keep the (other) half busy taking care of them when they could be fighting and winning on the battlefield.

He also said it would be immoral not to use vaccine currently available, even while experts work to develop a better one.

We dont want to make anybody sick , but I also dont want to sit in front of you some day, after we send a force into harms way, have them run into an aerosolized anthrax exposure and explain to you why we had hundreds of thousands of deaths when we had protection available to keep them from dying.

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