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Feds Study Long-term, Other Anthrax Vaccine Effects, de Leon Notes

By Staff Sgt. Kathleen T. Rhem, USA
American Forces Press Service

WASHINGTON, April 19, 2000 – Federal agencies are collaborating in a major study into long-term health effects of the anthrax vaccine used by DoD, Deputy Defense Secretary Rudy de Leon testified April 13 before the Senate Armed Services Committee.

The Centers for Disease Control in Atlanta heads the $20 million, multiyear study and is working with DoD, the Food and Drug Administration and the National Institutes of Health, de Leon said in a prepared statement. The study will document possible long-term effects and examine risk factors for adverse reactions and dosing.

"The DoD leadership ... are aware of and respect the concerns expressed by a small number of service members about possible long-term health effects," de Leon said. At least 12 studies involving more than 16,000 vaccine recipients have been conducted and show common short-term side effects include local injection site reactions, headache, slight fever, joint pain and fatigue.

Program officials have said women seem nearly twice as likely as men to have a local reaction at the injection site. Currently, the anthrax vaccine is injected subcutaneously, or directly below the skin. The new CDC collaboration will seek to determine if the vaccine is as safe and effective if injected into muscle, which may reduce localized reactions, a DoD anthrax immunization program official said.

The study will also look at whether the current six-dose regimen could be cut to five or even four shots and whether individuals need annual booster shots, the official said.

A second, separate long-term study is following 570 test and control subjects previously employed at Fort Detrick, Md. De Leon said the purpose of the study, begun in 1996, is to examine the effects of receiving multiple vaccines, including the one for anthrax.

"All volunteers signed an approved informed-consent document. The study media included a nine-page health history questionnaire, extensive blood tests and urinalysis," de Leon said in his testimony. "The questionnaire queries mental and physical conditions of progeny as well as the health of the volunteers. Study end points include symptoms, ... diseases, [and] abnormal laboratory and urine tests."

In his testimony, the deputy secretary also told Congress that DoD urges all members who believe they've had an adverse reaction to report it through the FDA's Vaccine Adverse Event Reporting System.

"Not only are members encouraged to submit a report, but families or anyone personally aware of a situation can as well," he said. "We listen. We are concerned."

Individuals can file FDA adverse event reports on DoD's anthrax Web site at www.anthrax.osd.mil, or by calling the FDA's toll-free information line, 1-800-822-7967. The site also presents current reporting statistics for DoD's anthrax immunization program.

De Leon's statement reiterated DoD's resolve to vaccinate all service members in high-risk areas. "Currently, about a dozen nation states are known to possess or have in development a biological warfare capability. There is also evidence that a small number of terrorist groups appear to be interested in biological agents," he said. "Of all known biological warfare agents, anthrax spores are the top choice ... for germ warfare."

He said Iraq has admitted to producing anthrax spores and putting them into weapons. Furthermore, he said, the death of 64 people by anthrax in a 1979 accident at Sverdlovsk (now Ekaterinburg), Russia, demonstrates the former Soviet Union's research with the organism.

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Related Sites:
Deputy Secretary of Defense Rudy de Leon, Prepared Testimony on Anthrax Vaccination Immunization Program, submitted to the Senate Armed Services Committee, April 13, 2000

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