Chiron gets FDA nod to ship flu vaccine

Oct 13, 2005 (CIDRAP News) – Armed with full federal approval for the first time in more than a year, Chiron Corp. says it may start shipping influenza vaccine to US distributors next week.

Chiron's first shipments since contamination problems blocked the company's vaccine shipments last year could help ease vaccine shortages caused by slow deliveries, a Centers for Disease Control and Prevention (CDC) official said.

The Food and Drug Administration (FDA) yesterday approved the first three lots of Chiron's Fluvirn vaccine for shipment, according to company officials. The lots amount to about 1.5 million doses.

Chiron spokeswoman Alison Marquiss in Emeryville, Calif., said the company needs to complete its own testing on the three lots before shipping them, which could happen in a few days.

"We're very close to the finish line for these first lots," she told CIDRAP News. "We'd expect to release them to distributors in the coming days for them to ship to their customers."

In a survey of 120 local health departments last week, all but six reported that vaccine shipments were delayed or orders were not completely filled, according to an Associated Press report today. The survey was done by the National Association of City and County Health Officials (NACCHO).

The survey indicated that somewhere between zero and 40% of flu vaccine orders have been filled so far, Curtis Allen of the CDC's National Immunization Program in Atlanta told CIDRAP News.

"A lot depends on who they ordered from and when they ordered it," Allen said. "Many of those that have ordered from Sanofi [Sanofi Pasteur] have received at least 20% of their orders." He said Sanofi has been trying to make sure that customers get enough vaccine to cover people who have an increased risk of serious flu complications.

With Chiron having received FDA clearance, Allen added, "Hopefully those who have ordered vaccine from Chiron should be getting some soon."

In September the CDC recommended that flu shots be reserved for people in high-risk groups until Oct 24. Despite the delayed deliveries, the agency has no current plans to change that date, Allen said.

Contamination problems at Chiron's Liverpool, England, vaccine plant forced the company in October 2004 to cancel the planned shipment of about 48 million doses to the United States.

British authorities restored Chiron's manufacturing license last March, and the FDA inspected and approved the Liverpool plant in August. In September the FDA approved the company's vaccine formulation for this year. The agency also must inspect and approve each lot of vaccine before it can be shipped.

"The [FDA] release yesterday was the last regulatory step," said Marquiss.

"In the past year we've been working on remediating our facility and at the same time producing vaccine for this upcoming season," she said. "So what we're doing right now is a step that normally would've happened a month ago. We just need to catch up."

As reported previously, Chiron expects to produce between 18 million and 26 million doses of flu vaccine this year, Marquiss said. "Our third-quarter earnings report is October 25, so we hope to have a more concrete number then, or even before then."

She predicted it would take until early December to finish delivering vaccine for this season.

Allen said the CDC has not changed its estimate of flu vaccine supplies for this year: 60 million doses from Sanofi Pasteur, 8 million from GlaxoSmithKline, 3 million from MedImmune, and 18 million to 26 million from Chiron. That comes to 89 million to 97 million doses in all, as compared with about 60 million doses made available last year.

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