CHIRON ISSUED 'FAVORABLE' INSPECTION RESULTS

Chiron has made significant strides to bring its Liverpool, England, manufacturing plant into compliance with U.S. standards, but the embattled vaccine manufacturer still needs to make additional improvements before it can return its influenza vaccine, Fluvirin, to the U.S. market, the FDA said.

The agency issued Chiron a letter this week documenting the results of a nine-day good manufacturing practices (GMP) inspection that occurred in July at the Liverpool facility. The plant has been idle since last October, when the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a suspension order to Chiron for failing to comply with UK GMP regulations. The closing of the plant nearly halved the U.S. supply of flu vaccine last winter, causing shortages at facilities across the country.

"The letter that we issued to them this week is a positive development and shows significant progress on their part," Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said recently. "However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S."