Anthrax Vaccine's Safety Questioned

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Anthrax Vaccine's Safety Questioned
 

By THOMAS D. WILLIAMS
This story ran in the Courant July 21, 1999

 

Newly obtained U.S. Army and other military documents raise questions about the anthrax vaccine's safety and effectiveness in light of the positive way the U.S. Department of Defense has been advertising the vaccine.

The documents, from U.S. Army files, and interviews of doctors and others studying the vaccine reveal:

* Tests and studies of the vaccine on humans who were later exposed to anthrax do not prove it is effective against airborne anthrax spores used in biological warfare.

* The military is relying on laboratory tests of vaccinated monkeys exposed to airborne anthrax spores. Human responses to anthrax spores are assumed by scientists to be somewhat similar, but not identical to animal reactions.

* There have been no published, widespread studies of the long-term health effects of the vaccine on humans despite complaints from some of those injected that they are suffering from symptoms consistent with adverse reactions to the vaccine.

Inhaled anthrax is lethal to those who are unprotected. More than 307,000 military personnel have received the shot since 1998 under a mandatory program.

Those who refuse to take the shots -- estimated at several hundred -- are being court-martialed. At least 155 people in the Air National Guard have resigned rather than take it.

The vaccine's safety will be discussed at a hearing today before a House subcommittee on national security, co-chaired by U.S. Rep. Christopher Shays, R-4th District.

The defense department has a colorful Web site on anthrax that advertises the vaccine, approved by the U.S. Food and Drug Administration in 1970, as ``an ordinary vaccine . . . used safely for almost 30 years'' by a limited number of wool mill workers, veterinarians, laboratory workers and livestock handlers in the United States.

Army medical authorities, inside their own, less-advertised Web site, say that ``limited human data suggests that after completion of the first three doses, protection against [contraction of anthrax disease through the skin] is afforded. . . . There is insufficient data to know its efficacy against inhalational anthrax in humans, although studies in Rhesus monkeys indicate that good protection can be afforded after two doses . . .''

Those three studies were conducted on 43 monkeys vaccinated and then exposed to anthrax spores. All but one survived. The defense department's advertised Web site says the monkey data is ``compelling evidence that the vaccine series will be effective'' in protecting humans. But in a Sept. 3, 1991, memo, then- Secretary of the Army M.P.W. Stone said, ``Only widespread use can provide . . . accurate assessments of the types and severity of adverse reactions'' to the vaccine.

Dr. Meryl Nass, a Maine doctor who has studied the vaccine since it was used in the Persian Gulf War, said tests of monkeys show whether they die, not whether they have adverse reactions or long-range sicknesses.

In order to know whether the vaccine protects humans and whether it is safe and effective, humans need to be studied, most doctors and scientists agree, Nass said.

Dr. Robert Myers, owner of the company that produced the vaccine, said company tests on rabbits and the rigorous FDA licensing process show it is safe.

A group of scientists and researchers will meet July 29 to discuss a new study of the possible long-range health effects of the vaccine on humans.

 

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