Excerpted from Arkansas Democrat-Gazette, by Rod Hafemeister.

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.

Food and Drug Administration records show that the state-owned Michigan Biologic Products Institute re-labeled a 1993 batch of anthrax vaccine in February to extend its shelf life past 1996. Sailors on two aircraft carriers [Some of whom are the same sailors who refused the vaccinations that we reported on in the last issue–Ed.] in the Gulf say medical records list that same batch–FAV020–as the one given to the sailors in April, according to interviews.

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 weren’t validated as effective nor was their integrity tested.
• No written justification existed for re-dating 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 re-tested until they passed, with no explanation of why they failed.

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. [Nevertheless, the military never halted administering the vaccine to the troops.–Ed.]