EMERYVILLE, Calif. -- Chiron Corporation announced that it has received notice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that the MHRA proposes to continue the suspension of the company's license to manufacture influenza vaccines in Liverpool for a further period of three months, effective January 4, 2005, at the same time as the expiration of the initial three-month suspension.
A spokesperson for the UK Department of Health stated that the extension of the suspension "does not result from any newly identified safety issues or findings at the Liverpool plant," and called it "routine regulatory action" that will give Chiron more time to carry out its remediation plan, which is currently underway. The spokesperson also stated that the suspension could be lifted at any time upon satisfactory compliance with the facility's license. The MHRA has worked closely with the U.S. Food and Drug Administration (FDA) on these issues, and the agencies plan to examine progress at the facility throughout the remediation process.
In order to meet timelines for delivery of FLUVIRIN® influenza virus vaccine for the U.S. market, production must begin no later than early spring of 2005. The MHRA notice fulfills an agency requirement to allow Chiron a 28-day period to appeal the notice. Chiron does not intend to pursue this option.