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Panel Says Anthrax Vaccine Is Safe

 

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03/06/2002 1:07 PM EST

By RANDOLPH E. SCHMID

The currently available anthrax vaccine, while in need of improvement, is safe and effective, a panel of the National Academy of Sciences reported Wednesday.

"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," said Brian L. Strom, chairman of the committee that reviewed the vaccine.

The committee urged the Defense Department to support research into a better vaccine.

The current vaccine was approved by FDA in 1970. The manufacturer, BioPort Corp., took over the product in 1998, but not until February did it win FDA approval for full production.

The delays hampered availability of the vaccine, limiting efforts by the military to vaccinate all service personnel.

Only a small number of special mission forces have been getting the vaccine. Some 400 soldiers, fearing complications from a vaccine they considered experimental, had refused it.

The new report was welcomed by the Pentagon.

"This peer-reviewed report ... offers confirmation that the department uses a protective measure that works for those at risk of exposure to the lethal agent anthrax," said Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs.

Strom said the study, which had already been under way, was expedited after last year's terrorist attacks.

Concern about the limited supplies of the vaccine was heightened by last fall's anthrax-by-mail terrorism coupled with the fear that the disease could be used as a weapon by foreign terrorists.

The new report from the National Academy of Science's Institute of Medicine found no unexpected adverse effects from taking the vaccine. The rate of reactions was similar to that of other vaccines, such as tetanus, given adults. These included skin redness and occasional malaise and muscle pain but no serious health impairments, the report said. There were also reports of itching or swelling at the injection site.

The report said this may be because the vaccine is injected under the skin rather than into muscle, which is done for most vaccines.

There is only limited information about possible long-term effects, the report noted, but there are no indications of increased risks.

But the vaccine is manufactured using older technology and requires six shots plus an annual booster, something the committee felt should be improved.

"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," said Strom, director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania.

The current vaccine has been used to protect veterinarians and others who work with animals.

Normally anthrax is a disease of animals, and humans have contracted it from handling or working with the animals. Anthrax spores can live for years.

Five people died from the inhaled form of the disease, including two postal workers, after letters containing anthrax were sent to people in Florida, New York and Washington, D.C., last fall.

There are also skin and intestinal forms of the disease if the bacillus is contacted by the skin or eaten.

BioPort, of Lansing, Mich., will produce 2 million vaccine doses this year, and between 3 million and 8 million next year, according to Health and Human Services Secretary Tommy Thompson.

The government does not recommend the vaccine for civilians, but officials want to have it on hand in case of need.

Committee member Dennis Kasper, executive dean for academic programs at Harvard Medical School, said several studies had evaluated the effectiveness of the vaccine against the deadly inhaled form of anthrax, including tests in chimps and monkeys.

The researchers said the vaccine can also be used after exposure to anthrax, accompanied by antibiotics to protect the patient until the vaccine takes effect.

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On the Net:

National Academy: http://national-academies.org/

BioPort: http://www.bioport.com

FDA: http://www.fda.gov

Defense Department: http://www.defenselink.mil/

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.