FDA APPROVES FIRST LOTS OF CHIRON'S FLUVIRIN

Chiron will soon begin shipping flu vaccine to U.S. distributors for the first time since its operations were shuttered roughly one year ago because of manufacturing deficiencies.

The FDA recently approved three lots — approximately 1.5 million doses — of Chiron's influenza vaccine Fluvirin, clearing the way for the firm to resume shipments of the product. The company now needs to complete its own testing on the three lots before shipping them, which could happen in a few days, said Chiron spokeswoman Alison Marquiss.

"We're very close to the finish line for these first lots," Marquiss said. "We expect to release them to distributors in the coming days for them to ship to their customers."

Chiron has said it expects to produce 18 million to 26 million doses of Fluvirin for this year's flu season. The company will update that projection later this month when it releases its third-quarter earnings, Marquiss said.

The FDA's approval of the three Fluvirin lots comes roughly six weeks after the agency completed a favorable inspection of Chiron's Liverpool, England, manufacturing plant. The plant had been idle since last October, when the UK's Medicines and Healthcare products Regulatory Agency issued a suspension order to Chiron for failing to comply with UK GMP. The closing of the plant nearly halved the U.S. supply of flu vaccine last winter, causing shortages at facilities across the country.

The FDA is expecting another 60 million to 70 million doses of flu vaccine this winter from three other manufacturers. Sanofi-pasteur is planning to produce up to 60 million doses for the U.S. market, GlaxoSmithKline is expecting to provide up to 8 million doses, and MedImmune is planning to produce 3 million doses of its nasal-spray vaccine. Assuming Chiron and the other firms meet their production targets, the U.S. would receive 89 million to 97 million doses in all, compared to roughly 60 million doses made available last year.