FDA finds Chiron influenza vaccine unsafe for use

Oct 16 2004

The U.S. Food and Drug Administration has found that none of the influenza vaccine manufactured by the Chiron Corporation for the US market is safe for use.

This determination is based on FDA's evaluation and inspection of Chiron's influenza vaccine manufacturing plant in Liverpool, England, which concluded this afternoon.

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.

The safety of the vaccine supply is of the highest priority to FDA and the Department of Health and Human Services. FDA has today provided Chiron with our inspectional observations and has met with the company to evaluate their response and assure that the necessary corrective actions are taken. We will work with Chiron and the UK government in correcting the deficiencies in the plant.

The Department of Health and Human Services will continue to exhaust every avenue to secure more flu vaccine for this season. Literally every known manufacturer of flu vaccine in the world is being contacted and some progress is being made. Additionally the quarantined lots of Chiron vaccine already in the United States are being ever further evaluated. We do not want to create false hope but we want to explore every option.