Chiron's Liverpool Plant Gets OK From MHRA

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has given Chiron the go-ahead to operate its Liverpool plant for the first time since the vaccine-manufacturing facility's license was pulled five months ago.

The Liverpool plant has been out of commission since Oct. 4, 2004, when the MHRA issued a suspension order to Chiron for failing to comply with UK good manufacturing practice regulations when producing its flu vaccine Fluvirin. The closing of the plant nearly halved the U.S. supply of flu vaccine this winter, causing shortages at facilities across the country.

"MHRA inspectors have been working closely alongside the company since the manufacturing license required to produce the vaccine was suspended toward the end of 2004, following problems with the manufacturing plant and process," the agency said. "The MHRA inspectors have concluded that satisfactory progress has been made in the manufacturing areas which had previously caused concern. Their findings were considered at the MHRA's Inspections Action Group (IAG) on March 1, and the IAG's recommendation to lift the suspension was accepted by the MHRA on the same day."

Chiron said the MHRA's decision to lift the suspension is conditioned on the understanding that the company's "high level of commitment to the completion of its remediation plan and ongoing improvements will continue." Chiron noted that it will provide the MHRA with weekly updates to ensure that progress on its various remediation projects proceeds satisfactorily.