Sailors in the Persian Gulf say the Navy is no longer using a batch of anthrax vaccine that was improperly relabeled after it expired, but the new batch is one that also was criticized by federal inspectors for quality control problems.
The new batch, lot number FAV 030, is one of three batches that were mixed from a group of smaller batches made between April 1994 and February 1995 at Michigan Biologic Products Institute, the only licensed manufacturer of the vaccine.
In February 1998, U.S. Food and Drug Administration inspectors cited the lab for a variety of problems, including its failure to properly track “multiple contaminations with microorganisms in sublots.”
A copy of the inspection report, obtained under the Freedom of Information Act, has the actual number of sublots produced during the 10-month period blacked out. But it states that “23 were discarded due to some kind of microbial contamination.”
“Lots FAV 029, FAV 030 and FAV 031 were whole or partially formulated from those sublots not discarded in this time period,” the report said.
The report goes on to state that in early 1997, five of 12 sublots were discarded for microbial contamination while the other seven were used in another batch of vaccine. Two other batches had similar problems in fall 1997.
The Pentagon began anthrax vaccinations this year, saying it was the best way to protect against the disease being used as a weapon. Critics say the vaccine has not been proven effective and may be dangerous.
The Belleville News-Democrat reported in May that the first round of more than 20,000 anthrax vaccinations used a batch that FDA inspectors said had expired but was relabeled and released without testing for safety or purity.
The FAV 030 batch is listed in the medical records of Petty Officer First Class Daniel Norris, a 30-year-old sailor from California on the cruiser USS Valley Forge, currently in the Gulf. Sailors on the Valley Forge and other ships in the Gulf began receiving anthrax vaccinations last month.
Norris initially refused to take the vaccination but acquiesced after
the ship’s captain, Cmdr. William Hoker, threatened him with disciplinary
action, said his wife, Michelle Norris. Last week, she resigned as the
ship’s volunteer ombudsman in protest.
Originally Published, Sept. 16, 1998, Belleville News Democrat, Belleville,
(c) 1998, Belleville News-Democrat, Belleville, Ill
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