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Posted on 04.23.02
The Anthrax Vaccine: It's Safe, It Works, and It Could Be Improved
By Janet Weiner, MPH
A decade before anthrax became a great concern for the general public last fall, the U.S. military considered it a threat to service members deployed during the Gulf War. To protect against possible exposure, the Department of Defense (DoD) gave the anthrax vaccine to about 150,000 service members at that time. (The vaccine, approved for use in 1970, is given in six shots over 18 months, and an annual booster dose is required.) Then, when it became clear that Iraq possessed anthrax bioweapons, the DoD began to implement a plan to vaccinate all service members in 1998.
As more service members received the vaccine, however, some questioned its use, fearing that it could be connected with complaints of multiple illnesses. These concerns prompted Congress to request, and the DoD to support, an Institute of Medicine (IOM) committee to study how well the vaccine works and how safe it is.
The committee's work became increasingly urgent as anthrax spores were deliberately distributed through the U.S. mail last fall. People with possible exposure to the bacteria were given antibiotics for months at a time; many people questioned whether they could take a vaccine for protection in the event of future exposure.
In response to these concerns, the IOM committee accelerated its work and issued a report in March 2002. The committee was chaired by Brian L. Strom, MD, MPH, a professor of biostatistics and epidemiology, medicine, and pharmacology at the University of Pennsylvania. He also directs the UPenn CERTs, which focuses on the treatment and prevention of infectious disease.
After reviewing all available studies, published and unpublished, and reports of adverse events with the vaccine, and hearing testimony from those who felt they were injured by the vaccine, the committee concluded that the anthrax vaccine is sufficiently safe to be useful and produces reactions comparable with those occurring with other vaccines given to adults, such as the tetanus shot.
"The anthrax vaccine should protect against even the inhalational form of the infection, but the lengthy vaccination schedule and the way the shots are physically administered make it far from optimal; it also is manufactured using older technologies that can be improved upon," Dr. Strom said. "The most prudent course of action is to develop a new vaccine--given the nation's war against terrorism and the domestic attacks where anthrax was used as a deadly weapon. In the meantime, the current vaccine is sufficiently safe and effective to be useful."
The report outlined the characteristics of a new and improved vaccine:
- It should require only two or three injections.
- It should provide immunity within 30 days that lasts for at least a year.
- It should remain potent for a long period. This would allow stockpiling, to ensure ample supplies when needed.
No plans exist to vaccinate the U.S. population as a whole. Roughly 2 million doses of the vaccine have been given, mostly to U.S. military personnel. Although the IOM report took no position on whether the DoD should continue its mandatory vaccination program, it did recommend that the DoD strengthen systems to detect health problems that might occur months or years after the vaccine is given.
The IOM report is available online.