Research Said Lacking on Vaccine

By Catherine Strong

Associated Press Writer
Tuesday, Oct. 12, 1999; 6:47 p.m. EDT

WASHINGTON –– Lawmakers said Tuesday they were skeptical of DefenseDepartment assurances that the anthrax vaccine is safe and that shots givento soldiers are having no effect on troop readiness and morale.

Defense Secretary William Cohen last year ordered all 2.4 million active duty and reserve troops to get shots of the anthrax vaccine as protection against biological warfare. Some 340,000 service members have been immunized so far. About 200 to 300 have refused to take it because of concerns about its safety and efficacy.

At a House hearing, lawmakers questioned Pentagon officials' assertions that the number of adverse reactions to the shots was small and there was no impact on troop readiness.

"Either the Defense Department is being less than forthcoming about objections being raised (among troops), or they have their heads buried in the sand," said Rep. Dan Burton, R-Ind., chairman of the House Government Reform Committee.

Military officers and federal health officials have repeatedly said the drug is safe and inoculation is the only known way to prevent rapid deaths in troops who inhale anthrax.

"We are confident that the anthrax vaccine is safe and effective," said Kathryn Zoon of the Food and Drug Administration.

But Kwai-Cheung Chan of the Government Accounting Office, the research arm of Congress, said his review of the studies available on the anthrax vaccine since the 1960s showed its long-term safety is unknown.

He also said there has been no specific study of the efficacy of the licensed vaccine in humans who have inhaled anthrax spores. Such studies have been conducted using guinea pigs, rabbits and monkeys.

The only study focusing on humans involved mill workers and others whose skin was exposed by touching infected animals. Anthrax is a naturally occurring bacteria found in domesticated animals.

"You have not tested this vaccine thoroughly," Burton said.
But Dr. Sue Bailey, the Defense Department's assistant secretary of health, said it would be unethical to test anthrax spores on humans.

Chan said a recent survey of soldiers at the Tripler Army Medical Center in Hawaii indicated women had a higher reaction rate to the vaccine than men. Twice the number of women reported they missed one or more duty shifts after a shot, and women were more than twice as likely to report fever, chills or general malaise.

"Clearly, we need to determine if there is any gender difference" through further research, Bailey conceded.

The FDA specified that troops are to have six shots with an annual booster to ensure they are properly inoculated. But Chan said no studies had determined the optimum number of shots required.

"There's a lot of unknowns that need to be looked into," Chan testified.

Anthrax has never been used in combat, but the Pentagon fears Iraq, North Korea and other countries – or terrorist groups – might try.