None of Chiron Corp.’s flu vaccine made at a British plant is safe for distribution in the United States, acting Food and Drug Administration Commissioner Lester Crawford said on Friday.
FDA inspectors have determined that Chiron’s entire manufacturing process for the vaccine was unsafe and they have rejected all of the 48-odd million doses at the facility.
“All the lots produced by the plant are suspect at this point and we cannot allow them to be used in the United States in the interest of public health,” Crawford told reporters in a telephone briefing.
Last week, British regulators suspended Chiron’s license for the vaccine plant, throwing half the expected U.S. influenza vaccine supply into doubt. Chiron found and reported contamination with a bacteria called Serratia, but had hoped to correct the problem in time to save most of the vaccine production.
“The problems that we found in the plant in the U.K., in Liverpool, were what we call good manufacturing practice violations,” Crawford told reporters in a telephone briefing.
“What this is, is in the manufacturing of vaccine the plant must assure and take appropriate steps to be certain that the vaccine is not contaminated with bacteria or other microorganisms or even chemicals,” Crawford added.
Problem not isolated to a few batches
But Crawford said whatever went wrong apparently affected everything Chiron made at the plant, which the California-based company acquired when it bought a British company called PowderJect.
“The system was such that a small number of the lots were in fact contaminated. As we tried to assure ourselves that this was isolated to those few lots, we were not able to do so,” Crawford said.
Crawford said the FDA would certainly have found the problems, because even if Chiron had verbally reported it cleared up the problems the FDA would have tested the vaccine before releasing it and would have found the contamination.
“They always knew it had to go through this lot release system,” he said.
Crawford said the FDA and British regulators would work with Chiron to get the plant into good shape for next year’s flu season. Influenza vaccine takes months to make and preparations should start in January for next season’s vaccine.
