Anthrax study conducted as supplies run low

National Guard, May 2000

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

This came a day before a GAO report that says that the DOD will run out of anthrax shots by July, unless new supplies are generated.

The vaccine is manufactured solely by the Bioport Corporation, which has had financial and safety troubles lately and is lagging behind schedule. If more supplies are not generated, the anthrax program could be temporarily suspended.

The Centers for Disease Control in Atlanta is in charge of the $20 million, multi-year study and is working with the 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 for the vaccine.

"The DOD leadership ... [is] aware of and respects 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, an 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.

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

Individuals can file FDA adverse event reports the anthrax Web site at www.anthrax.osd.mil, or by calling the FDA s toll-free information line, (800) 822-7967. There is also the DOD information line, (877) GET VACC, and there is now a video available.