Magazine article Insight on the News

What Are You Taking for That? Although the Anthrax Vaccine Routinely Is Administered to Those at High Risk of Exposure to the Disease, Many Experts Doubt the Vaccine's Safety and Effectiveness. (Nation: Antrax Vaccine)

Magazine article Insight on the News

What Are You Taking for That? Although the Anthrax Vaccine Routinely Is Administered to Those at High Risk of Exposure to the Disease, Many Experts Doubt the Vaccine's Safety and Effectiveness. (Nation: Antrax Vaccine)

Article excerpt

The Department of Defense (DoD) has revived its Anthrax Vaccine Immunization Program (AVIP). Emboldened by a report issued last March by the Institute of Medicine (IOM), DoD made the anthrax vaccine part of the mandated protection for military personnel and emergency workers. DoD health-affairs spokesman Jim Turner says the program will make the vaccine "a condition of employment" for those at high risk of anthrax exposure.

But can this vaccine be trusted to be both safe and effective? Certainly there have been questions about its long-term systemic effects and even whether it causes birth defects. As INSIGHT was the first to report, it contains a suspect amount of the ingredient squalene, an oily substance otherwise used for silicone breast implants, that may cause adverse side effects (see the last word, Oct. 30, 2000; "Gulf War Illness Update" Feb. 28, 2000; "GAO Calls for Squalene Tests" April 26,1999; "Breakthrough on Gulf War Illness," April 19,1999).

An article published in the August issue of Experimental & Molecular Pathology by medical researchers Pamela Asa, Russell Wilson and Robert Garry shows that in some cases there have been adverse reactions to the vaccine similar to known squalene side effects found by other researchers. These include joint and muscle pain, dizziness, chronic headaches, low-grade fevers, chronic fatigue, weakness, seizures, memory loss and cognitive problems. However, the health-affairs wing of DoD as well as the Food and Drug Administration (FDA) both have dismissed such concerns and stated that studies already are in progress to evaluate the safety of the vaccine administered to troops.

Besides, say advocates of the vaccine, isn't it better to provide some protection from weaponized anthrax for U.S. servicemen and first-responders than to have none?

Not if the anthrax vaccine doesn't give much protection in the first place, say critics. And the anthrax vaccine may not protect against inhalation anthrax. A spokesman for FDRs Center for Biologics Regulation (CBER) says the label of the anthrax vaccine "does not contradict" protection against infection by inhalation anthrax, but the vaccine only is licensed by FDA to protect against infection by cutaneous (skin) anthrax.

That's true for men at least--no one knows for certain how it will affect women. While the product label advises against giving the vaccine to pregnant women, no epidemiological tests have been done to evaluate how the vaccine reacts in a female body, pregnant or not, or even what it will do in the case of future pregnancies. The label says it's not known whether the vaccine "can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." Is this serious? Past safety monitoring shows that local and systemic reactions occur 50 percent more often in females than in males.

The primary human study of the vaccine is known as the Brachman test, run between 1955 and 1959 on wool-sorting workers in New England. DoD says that, based the Brachman findings, the vaccine is "92.5 percent effective" against cutaneous anthrax in the wool-mill setting. This suggests that of 100 people vaccinated for exposure to anthrax spores, seven to eight would contract cutaneous anthrax. The tests helped pave the way for an FDA license for the vaccine in 1970--a license for cutaneous-anthrax infections only.

There was an outbreak of inhalation anthrax also, but with too few cases to reach any conclusion about the effectiveness of the vaccine against anthrax contracted in that form. There also were too few female workers in the Brachman study to allow for conclusions, and what data there were about the women weren't separated from those on the men.

The only other data to establish the effectiveness of the vaccine against inhalation anthrax are animal tests. The DoD claims that five studies on rhesus monkeys were done in the mid-nineties. …

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