WASHINGTON, DC (October 18, 2004) – The Food & Drug Administration (FDA) said Friday that none of the influenza vaccine manufactured by Britain’s Chiron Corp. for the US market is safe for use.
The FDA said it based its determination on the agency’s 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 100 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 FDA said the safety of the vaccine supply is of the “highest priority to FDA and the Department of Health & Human Services.” The FDA said it has provided Chiron with the agency’s inspectional observations and has met with the company to evaluate theirresponse and assure that the necessary corrective actions are taken.
The agency said it planned to work with Chiron and the British government to correct the deficiencies in the plant. The quarantined lots of Chiron vaccine already in the United States are undergoing further evaluation, the FDA said.
Meanwhile, the Department of Health & Human Services said it will “continue to exhaust every avenue” to secure more flu vaccine for this season. The department said it is contacting “literally every known manufacturer of flu vaccine in the world” and that some progress is being made.
