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July 25, 2005
Anthrax inoculation extension sought

By Deborah Funk
Times staff writer
http://www.airforcetimes.com/print.php?f=0-292925-994696.php

The Pentagon may continue its voluntary anthrax vaccination program for about another six months, until Jan. 14.

The Food and Drug Administration on July 22 extended the “emergency use authority” it granted the Defense Department in January that allows the military to use the vaccine for a purpose other than for which it is licensed. The new authority expires one year from the date that then-Health and Human Services Secretary Tommy Thompson declared an “emergency” that justified the use of the vaccine, the first such emergency declared under a relatively new provision of federal law.

A federal judge ruled last fall that anthrax vaccine was licensed to protect against an anthrax infection of the skin, but was not licensed for protection against inhalation anthrax, the form of the disease that the Pentagon says is a germ warfare threat to U.S. forces.

The judge’s ruling put an end to the Pentagon’s seven-year-old mandatory anthrax vaccination program, but the Pentagon was allowed to resume vaccinations under a provision in federal law that allows drugs to be used on a large scale for purposes other than what their license permits. In granting the permission, however, FDA said the program had to be voluntary rather than mandatory, and troops cannot be punished in any way for declining the shots. Under the old program, troops who refused risked legal or administrative action.

Since the first shots under the voluntary program were offered in May, the response has been muted, with about half of the troops and civilians accepting the vaccine, and the other half rejecting it.

The vaccine is offered to troops and civilian workers who will be in South Korea or in the Central Command area of operations — mainly Southwest and Central Asia — for at least 15 consecutive days.

Meanwhile, the FDA is reviewing public comments in considering whether to license the vaccine to protect against inhalation anthrax, an intention the agency announced earlier this year.