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 plant’s
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 didn’t 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 doesn’t 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 didn’t 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 isn’t 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 wasn’t 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 don’t want to make anybody sick … , but I also don’t want to sit
in front of you some day, after we send a force into harm’s 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.”