As many as one-third of all military personnel who receive the anthrax vaccine may have systemic reactions such as aches, rashes, chills, fevers or nausea, Pentagon officials now admit.
That includes Lt. Gen. Ronald Blanck, the Army’s surgeon general who oversees the program.
Mark Zaid, an attorney who has represented service members who refused the vaccine and who is executive director of the James Madison Project, a nonprofit organization dedicated to government openness, last month filed a petition with the Food and Drug Administration asking it to change the product insert to reflect the true systemic reaction rate of 5 to 35 percent, instead of the current 0.2 percent, which is based on a study of a slightly different vaccine in the 1950s.
Zaid said he was shocked in late December when he received a letter from Blanck admitting the higher rates.
“It wasn’t requested. It was in response to a petition (against the vaccine) that we did over the Internet,” Zaid said. “The Department of Defense has repeatedly misled the public concerning information surrounding the anthrax vaccine. Internal military studies revealed a significantly higher reaction rate to the vaccine, but the DoD did its best to hide this information for as long as it could.
“The petition forces the FDA to now recognize what the DoD has known for years. This is going to be the first time the FDA is going to have to take action concerning this vaccine.
“I can tell you that should we not get a positive response, we will go ahead and litigate.”
The anthrax vaccine is different from most vaccines because of the number of shots needed. Full immunization requires six shots — three shots two weeks apart, followed by shots at six, 12 and 18 months — followed by annual booster shots.
Since the product insert says that systemic reactions could be a reason to exempt people from receiving further shots, such a change could effectively remove hundreds of thousands of troops from the vaccination program.
But Zaid doesn’t expect such a change without a fight — in his letter, Blanck stated that “almost all” of the systemic reactions clear up within 24 to 48 hours without medical intervention.
“Serious reactions are rare, but they can happen with the anthrax vaccine as with other vaccines,” Blanck wrote.
Blanck’s spokesman did not return calls seeking comment.
But his admission is a major change from initial Pentagon statements, when spokesmen argued no one would have any reactions to the shot.
When they announced the servicewide vaccination program in December 1997, military leaders dismissed any problems with systemic reactions — body reactions away from the site of the shot, as opposed to local reactions such as swelling and redness around the shot.
They stuck to that argument for almost two years, despite growing evidence that reaction rates were much higher than the 0.2 percent and claims by some service members that they were suffering serious, long-term problems.
Last year, General Accounting Office investigators told a congressional
panel that, based on the Pentagon’s own unpublished studies, that the systemic
reaction rate varied from at least 5 percent to as much as 35 percent or
more and that women appeared to have twice as many reactions
Since then, military leaders and spokesmen have been calling the reaction rate comparable to other vaccines and avoiding discussions of actual numbers.
And in the weeks just before Blanck’s letter, the Pentagon quietly replaced dozens of Internet Web pages and documents citing the 0.2 percent rate with new ones using the 5 to 35 percent figure.
Originally Published, March 27, 2000, Belleville News Democrat, Belleville,
(c) 2000, Belleville News-Democrat, Belleville, Ill.
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