The U.S. Navy injected sailors in the Persian Gulf with a 5-year-old batch of anthrax vaccine, two months after federal regulators said the vaccine had been given a new expiration date improperly.
That's according to U.S. Food and Drug Administration records that show the state-owned Michigan Biologic Products Institute relabeled a 1993 batch of anthrax vaccine in February to extend its shelf life past 1996.
Sailors on two aircraft carriers in the gulf say medical records list that same batch - FAV020 - as the one given to the sailors in April, according to interviews.
There is no indication the vaccine could harm the sailors, but the FDA can't certify that it's safe either.
Changing the date of a vaccine is legal, FDA spokesman Lenora Gelb said, but the product has to be recertified as safe and effective. Batch FAV020 was tested for potency, but not for other problems, FDA records show.
The Michigan plant made all of the more than seven million doses of anthrax vaccine the Pentagon said it will use this summer to begin its program to vaccinate every active duty, reserve and National Guard service member - 2.4 million in all.
But FDA records show that since 1993 the Michigan plant repeatedly has been cited for violations of the FDA's Good Manufacturing Practices rules and other quality control problems.
The records were obtained through the Freedom of Information Act and with the help of GulfWatch, a veterans' advocacy organization based in Hannibal, Mo.
The records include a March 11, 1997, letter from the FDA threatening to revoke the plant's licenses if it did not correct its problems.
In February, FDA inspectors spent two weeks in the plant, with much of their attention focused on the anthrax vaccine line, and concluded: "The manufacturing process for anthrax vaccine is not validated."
Among the problems:
* Vaccine was being stored for years at a time with no way of telling whether the vaccine remained effective and uncontaminated.
* Different batches of vaccine with widely varying manufacturing dates were mixed together to create a final batch.
* Until August 1997, filters used to harvest the vaccine were not validated as effective nor was their integrity tested.
* No written justification existed for redating batches of vaccine that had expired, and there was no proof the plant had even tested the batches for contamination before giving them new expiration dates. Batches that failed potency tests were sometimes retested until they passed, with no explanation of why they failed.
Run by the Michigan Department of Community Health, Michigan Biologic Products Institute is the only licensed manufacturer of anthrax vaccine for humans in the United States.
For decades, the plant made relatively small amounts of anthrax vaccine for veterinarians and other workers who could be exposed to the deadly livestock disease.
But the vaccine has gained new attention in recent years, in part because Iraq's Saddam Hussein had an active biological warfare program and in part because anthrax is believed to be one of the easiest biological weapons for terrorists to make.
"We know there have been problems and we are working on them," said Geralyn Lasher, spokesman for the Michigan Health Department. "But remember, the anthrax vaccine has more testing done on it than pediatric vaccines."
Vaccine batches submitted to FDA for new expiration dates are supposed to be relabeled with an alternate Lot Number that indicates it has been redated. Inspectors found that didn't happen, specifically identifying Lot FAV020, which was originally dated as being tested for potency on April 13, 1993, and redated on Feb. 6, 1998.
Sailors on both the USS Independence and the USS Stennis in the Persian Gulf in April received vaccinations from Lot FAV020, according to three sailors on the ships who say that lot number is in their medical records. The sailors were reached through Lori Greenleaf of Morrison, Colo., whose son Eric Julius is stationed on the USS Independence.
One of those sailors reached aboard the Independence was Nhut M. Nguyen, who refused the shots but claims other sailors' medical records show the questionable batch number.
An estimated 14 sailors on the two ships refused to take the shots and have received administrative punishments ranging from reductions in rank to discharge from the Navy.
Navy spokesmen did not return repeated calls last week. Pentagon spokesmen referred questions to the Navy.
The Pentagon in March ordered anthrax vaccinations for all troops in the Persian Gulf, including the sailors on the Independence and the Stennis. After its February inspection, the FDA didn't close the Michigan plant - they didn't get the chance.
The anthrax line was shut down in March to begin an 18-month, $20 million renovation program paid for by the Army.
But in an April 7 letter, John Taylor III, FDA's senior advisor for regulatory operations, warned that Michigan Biologic Products needs to make "significant improvements" before resuming production.
Critics think the FDA buckled to pressure from the Pentagon and let the Michigan lab off easy.
"The FDA has really been talking out of both sides of their mouth - the standards were sloppy but the product was fine," said Lingg Brewer, a Michigan state lawmaker who has been investigating the lab.
Meryl Nass, one of the few nonmilitary doctors who has studied anthrax, said she was appalled by the FDA reports.
"It seems that thousands of vials were discarded if there was visible evidence of contamination or development of particulates," she said. "But the remaining vials in those lots (batches) were released for use in people without further testing."
Pentagon officials maintain the anthrax is safe and effective On Friday, Defense Secretary William Cohen announced that the Pentagon will proceed this summer with its plans to vaccinate 2.4 million active duty, reserve and National Guard service members over the next six to seven years.
The same day, President Clinton called for stockpiling up to 30 million doses of vaccine for defense against biological terrorism.
Attorneys for Veterans for Integrity in Government, a Washington, D.C., advocacy group, have been attempting to stop the anthrax vaccination program, arguing that the Pentagon cannot show that it will either work against anthrax used as a weapon or that it is safe in the long term.
Originally Published, May 25, 1998, Belleville News Democrat, Belleville,
(c) 1998, Belleville News-Democrat, Belleville, Ill.
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