The oft maligned U.S. anthrax vaccine, suspected of causing everything from tinnitus to fatal anemia, received a vote of confidence this week from a panel at the Institute of Medicine (IOM). Headed by Brian Strom, chair of biostatistics and epidemiology at the University of Pennsylvania in Philadelphia, the panel found "no evidence" that the vaccine has caused life-threatening or disabling health problems.
Addressing questions about efficacy, the panel noted that the anthrax bacterium is so dangerous that it would be unethical to test the potency of the vaccine in clinical trials. But the panel concluded that data from animal studies, combined with "reasonable assumptions," show that the vaccine is effective and can protect humans against "any known or plausible engineered strains of Bacillus anthracis."
The vaccine does have faults, however. It must be injected under the skin in a series of six shots. According to the IOM report, the vaccine can create swelling and nodules at the injection site, fever and malaise, and in some people a period of "brief functional impairment." Survey data show that some women in the military were so strongly affected they were briefly unable to carry out their duties. But the IOM experts saw "no convincing evidence at this time" of serious or delayed negative health effects.
The IOM group urges the military to fund new studies on what makes the vaccine work, including research designed to reduce the number of injections. The Department of Defense, IOM says, should increase its monitoring of possible long-term health effects and make clinical data available to scientists at other institutions. It concludes with a string of recommendations for expanded research on the anthrax bacterium and entirely new vaccines for the future.