US FDA has announced that none of the influenza vaccine manufactured by the Chiron Corporation for the US market is safe for use. FDA reached this conclusion after their evaluation and inspection of Chiron's influenza vaccine manufacturing plant in Liverpool, England.
The purpose of the FDA inspection was both to evaluate Chiron's investigation, testing and assessment of the defects detected in nine of the one hundred lots of their finished flu vaccine (Fluvirin) manufactured for this year's flu season and also to evaluate their determination that the risk of defects was confined to those specific lots.
US FDA has provided Chiron with the inspectional observations and has met with the company to evaluate their response and assure that the necessary corrective actions are taken. FDA will work with Chiron and the UK government in correcting the deficiencies in the plant, the release said.