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Scientific Group Finds Anthrax Vaccine Safe, Effective

By Sgt. 1st Class Kathleen T. Rhem, USA
American Forces Press Service

WASHINGTON, March 8, 2002 – The current anthrax vaccine used by DoD is safe and effective in protecting against all forms of the deadly disease, according to a new report.

The Institute of Medicine, a private, nonprofit scientific organization, released its findings in a comprehensive report March 6.

The report states the vaccine, as the Food and Drug Administration currently licenses it, is effective protection against anthrax, including inhalation anthrax.

In 1998, the Defense Department began an aggressive program to vaccinate all service members against the disease, which is a feared biological warfare agent. The vaccination program came under public criticism amid concern about the vaccine's safety.

Critics became more vocal when the program was scaled back several times because of vaccine shortages. The sole manufacturer of the vaccine, Bioport, repeatedly failed to win Food and Drug Administration approval for a renovated facility in Lansing, Mich., and supplies of stockpiled vaccines dwindled.

However, the Bioport plant passed the final FDA inspection in January and was licensed to produce more vaccine. DoD officials are currently examining what form the vaccination program should take now.

To address service members' concerns, Congress in 2000 required DoD to seek an independent examination of the vaccination program. In October 2000, the Institute of Medicine convened the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. The committee sped up its efforts in response to the anthrax attacks through the mail in the fall of 2001. The report released March 6 is the culmination of that committee's work.

The committee affirmed the vaccine is "reasonably safe" in regards to immediate reactions. The report states temporary injection-site reactions such as pain, redness and swelling are fairly common but "are comparable to those observed with other vaccines regularly administered to adults."

DoD anthrax experts have said such reactions occur in about 30 percent of men and 60 percent of women. Such differences in reactions between the sexes are common in other vaccines as well, the report says. Though its finding was not unusual, the committee recommended that future studies of reactions include separate analyses for men and women.

The anthrax vaccine also doesn't seem any more dangerous in the long term than other vaccines, the report concludes. However, the committee mentioned that data are limited on long-term effects for all vaccines, and it recommended several ways for DoD to gather more data over time.

Critics have raised concerns that the vaccine wouldn't be effective against bioengineered or genetically altered forms of anthrax. Intelligence reports indicated the Soviet Union or others might have been working to develop such strains. This report debunks those concerns, saying the process needed to allow the germ to evade the vaccine would "alter and thus eliminate its toxic action."

The report also gives Bioport a vote of confidence. The committee members said they believe the steps the company took to earn FDA approval following its plant renovation will lead to "greater assurance of consistency" of the vaccine.

While the committee found the current vaccine is safe and effective as the military is using it, it noted the vaccine is "far from optimal."

The 18-month-long, six-shot regimen currently needed to produce maximum immunity makes the vaccine hard to administer properly. The current vaccine was licensed in the 1970s, and improvements in vaccine technology have made better vaccines "feasible," the report concluded.

The committee encouraged the work of DoD, the National Institutes of Health and other organizations to develop a better anthrax vaccine.

The full report is available online at www.iom.edu/iom/iomhome.nsf/Pages/ Recently+Released+Reports.

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