Anthrax Vaccine Failed Test

by Thomas D. Williams

The Hartford Courant

July 11, 2000

The last unapproved lot of anthrax vaccine available to the Pentagon's inoculation program failed a potency test three years ago, Food and Drug Administration inspection records reveal. According to federal rules, a vaccine that fails one test cannot be used unless the test itself is proven invalid.

Last week, Rear Admiral Craig Quigley denied the unapproved lot of vaccine - known as FAV022 - had failed recent tests, meaning within the past few weeks. But Quigley never mentioned federal records that show the lot failed a 1997 test.

Pentagon spokesman James Turner challenged a report last week by ABCNews.com that said the lot had failed a recent test. One recent test was stopped before it was completed, said Turner, and a second test was invalid, prompting renewed testing.

Turner, asked about the failed 1997 test, said he could not immediately obtain answers from those familiar with the lot.

"BioPort [the vaccine manufacturer] follows all of FDA's guidelines," said Kelly Rossman-McKinney, a BioPort spokeswoman. "Not a single dose will leave our facility without the approval of the FDA and the Department of Defense."

Potency tests determine whether the vaccine is strong enough to resist exposure to the anthrax bacterium. Recent tests have been done on vaccinated guinea pigs to see if they can withstand exposures to the bacterium. A passing test is required before the drug can be used on humans. The lot in question, as of December 1998, contained about 194,000 doses of the vaccine, according to federal records. The Pentagon is using about 4,500 doses a day to administer a mandatory series of vaccinations to service personnel. . About 455,000 service members have already received at least one dose of the six-shot inoculation aimed at protecting them from airborne anthrax spores said to be available to terrorists and enemy nations as biological weapons. The military has about 190,000 approved doses left.

FDA inspection records show that the disputed lot is more than six years old. It passed its first tests in 1993, but it was not used. Because approval for the vaccine expires within three years of the first passing test, the lot needed re-approval in 1996, and again in 1999.

Lenore Gelb, an FDA spokeswoman, said the agency will not allow lots that have failed inspections to be used.

The anthrax vaccination program has been under fire from some legislators, including U.S. Rep. Christopher Shays, R-Connecticut, who has questioned its effectiveness.

Many service people have questioned the vaccine's safety, complaining about side effects; the Pentagon has said the vast majority of adverse effects are minor. But dozens of service people have refused to take the vaccination and have been disciplined, and hundreds of reserve and National Guard members have resigned rather than take the vaccination.

Monday, Defense Secretary William Cohen said he has decided to reduce the scope of the vaccination program. Inoculations will be limited mainly to those troops who have already begun the series of shots, and those who are preparing to deploy to the suspected hotspots.