Published October 12, 2004
PHILADELPHIA – Pharmaceutical giant GlaxoSmithKline (GSK) is in talks with the Food and Drug Administration about selling its Fluarix influenza vaccine in the United States to help cope with an expected flu-vaccine shortage this season.
Glaxo is looking at ways to supply doses and increase production at its main flu-vaccine plant in Dresden, Germany, said Danielle Halstrom, a spokeswoman for the London-based company, which has U.S. headquarters in Philadelphia and Research Triangle Park, N.C.
The company said its current production capability "does not come close" to the 46 million to 48 million doses that were lost when Chiron Corp. (CHIR) had to shutter its vaccine plant in England last week because of concerns over contamination.
Glaxo currently only has about 500,000 doses available.
"If the FDA says 'Yes,' we will supply any unallocated doses we may have," Halstrom said, adding that the discussions began in the past week. "What the last two years have shown us: There is a need for GSK to be in the flu-manufacturing business in the United States."
The FDA could not be reached for comment by The Philadelphia Inquirer on Monday because federal offices were closed for Columbus Day.
Glaxo was examining a number of options that could help increase vaccine production in Dresden, as well as possibly expanding production outside Germany, Halstrom said.
When Fluarix (search) was introduced in 1992, the United States had five to 10 vaccine manufacturers. That number has dwindled to two makers of injectible vaccines: Chiron, based in Emeryville, Ca., and Aventis Pasteur, a unit of France's Sanofi-Aventis S.A. (SNY), which has a plant in Swiftwater.