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8/27/2004

Chiron to Delay Influenza Vaccine Distribution

Kate Traynor

Chiron Corp. announced this week that it is delaying the release of its influenza virus vaccine, Fluvirin, because some lots of the product did not pass sterility testing.

The company said in a statement that it expects to begin releasing 46–48 million doses of the vaccine in October for the 2004–05 influenza season.

At a press conference today, Centers for Disease Control and Prevention (CDC) Director Julie L. Gerberding downplayed the significance of Chiron's manufacturing problem.

"A few batches of the vaccine did not meet the stringent tests for sterility," Gerberding said. "This is something that happens from time to time. It happens almost every year. In this case, Chiron made the decision to take no chances and to really hold delivery of the vaccine until they had completely assessed their entire manufacturing process."

Gerberding said Chiron has told CDC that the company believes it has located the source of contamination and is "aggressively pursuing all steps" to remedy the situation and produce its allotment of vaccine.

"This is not a crisis," Gerberding said.

Influenza virus vaccine shortages in recent years have led CDC to recommend prioritizing the administration of vaccine to make certain those most in need of vaccine receive the annual shot. Gerberding said that Chiron's production delay should not result in the need to prioritize vaccination this year, as long as other vaccine manufacturers remain on track to deliver their products as expected.

Gerberding said hospitals should work with their vaccine distributor to ensure that enough vaccine is on hand to meet vaccine needs early in the season.

So far, she said, manufacturers are meeting projections to make more than 100 million doses of vaccine for the upcoming influenza season.

"Ultimately," Gerberding predicted, "all people who need flu vaccine should be able to get their shots" this season.