FDA rules out Fluvirin

FDA has determined that none of Chiron's Fluvirin vaccine produced for the 2004-05 season can be used, Acting FDA Commissioner Lester Crawford said Friday. FDA inspectors concur with the U.K.'s MHRA that CHIR did not comply with good manufacturing practices, making it impossible to assure the safety of the vaccine, he said.

Crawford added that inspections conducted over the last week indicate that contamination is more widespread than CHIR initially believed. The company detected contamination in nine of the 100 lots of vaccine it manufactured, but FDA inspectors have detected contamination in additional lots. The contamination probably occurred during filling operations, Crawford said. ...