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Controversy Surrounds Anthrax Vaccine

Manufacturing Woes continued...

No one is quite sure how much anthrax vaccine is available or will be available in the near future. That is because the FDA forced the sole U.S. manufacturer of anthrax vaccine to stop distribution two years ago after an inspection found 30 violations at the manufacturing plant. Those violations included vaccine safety and sterility problems.

BioPort Corp. of Lansing, Mich., has actually been making and stockpiling the vaccine again for over a year, but the reserves can not be used or distributed until it passes another FDA inspection. That could be as early as Thanksgiving, but there are no guarantees, officials say.

If BioPort does pass inspection, some 5.4 million doses of anthrax vaccine will be available for immediate distribution, Health and Human Services secretary Tommy G. Thompson said late last week. But Rep. Christopher Shays, R-Conn., who has held hearings on the anthrax vaccine, says it is unclear if the stockpiled doses are safe.

Military Discord

The anthrax vaccine used in the United States was developed during the 1950s and '60s and was licensed by the FDA in 1970. It is given as a series of six injections over 18 months and poses no risk of developing the disease because it is a killed vaccine.

Critics say there is no guarantee that the vaccine is effective against all strains of anthrax and that terrorists could conceivably manufacture vaccine-resistant strains to use as weapons. The only human study ever done in the U.S. evaluated the vaccine during an outbreak of anthrax among New Hampshire mill workers 40 years ago. It was found to be 93% effective in workers who got the vaccine, and studies in monkeys have shown similar rates of protection.

The main controversy surrounding the vaccine involves its safety, not effectiveness. Hundreds of military personnel have faced disciplinary actions since 1998 for refusing to take it, and about 50 have been court-martialed. The Government Accounting Office recently reported that a significant number of reserve and National Guard pilots have left the military rather than take the anthrax shots.

Nass says she has been contacted by many people in the military who blame the vaccine for chronic health problems. Most have been women, and most complaints have been symptoms such as chronic fatigue and pain, which are the same symptoms of several chronic diseases common in women such as fibromyalgia and lupus. There is no direct evidence that these symptoms are linked to the vaccine, however.

"The best information we have suggests that this vaccine is safe," Modlin says. "But a vaccine is only one means of protecting one's self from disease, and in this case there are other equally or more important things we can do. A vaccine is never going to be the answer to the problem. It is only one measure we can take to address it."

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