Tuesday, November 13, 2001

LANSING, Mich. (AP) The only American manufacturer of an anthrax vaccine is preparing for an inspection to decide whether it can be used, but opponents are trying to call attention to what they say are its potential dangers.
About 40 demonstrators protested the military’s anthrax vaccination program Sunday during rallies at BioPort Corp. and Michigan’s Capitol in Lansing.
They say the vaccine could be connected to complaints of chronic fatigue, bone and joint pain, memory loss and other problems, and that the military has not done enough to investigate the vaccine’s long-term effects or whether it can be given safely with other vaccines.
“Something is wrong with the vaccine. You don’t have to be a scientist to figure it out,” said Steve Robinson, a Persian Gulf war veteran who now works for the National Gulf War Resource Center, a veterans advocacy group.
He said testimony before Congress has proved that many questions about the vaccine are unanswered.
The vaccine hasn’t been distributed since 1998 because BioPort has failed to win approval from the U.S. Food and Drug Administration.
In the past, the FDA has said BioPort was not ensuring that its labs were sterile and properly ventilated. The FDA is scheduled to inspect BioPort again in mid-December, company spokeswoman Kim Brennen Root said yesterday.
If the FDA approves distribution, the government has said, the vaccine likely will go to troops and others at risk for anthrax exposure, including law enforcement and postal workers.
Protesters say BioPort and the Pentagon are ignoring signs of illness in some of the 500,000 troops who have been vaccinated. But Dr. Tom Waytes, Bioport’s medical director, said 18 studies indicate the vaccine is safe.
Dr. Waytes said an independent panel of civilian physicians has reviewed each of the 1,623 reports of adverse reactions to the vaccine.
The panel has found no pattern suggesting the vaccine causes more adverse reactions than any other vaccine, he said.
He also said hospital records show that troops who have been vaccinated are as healthy in the long term as people who haven’t been vaccinated.
Miss Root said yesterday that it would be at least mid-December before the vaccine could be administered. Health and Human Services Secretary Tommy G. Thompson had said on Oct. 23 that BioPort could be providing vaccines to the military by Thanksgiving.
Miss Root said BioPort will start a new production cycle later this month. FDA officials will monitor that cycle when they visit in mid-December.
The Pentagon originally wanted to vaccinate 2.4 million troops with BioPort’s vaccine, but the vaccination program is on hold because BioPort hasn’t been allowed to distribute it without FDA approval.

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