The Centers for Disease Control and Prevention and drugmaker Aventis Pasteur said in Washington today that 14.2 million doses of flu vaccine will be allocated over the next six to eight weeks to high-priority vaccine providers, including hospitals, long-term-care facilities, nursing homes and pediatric providers.
CDC Director Julie Gerberding, M.D., and Aventis Pasteur US President Damian Braga made the announcement at a media conference at HHS headquarters.
"This plan will help ensure that vaccine gets to those people who need it most," said Gerberding in a news release. "This is a troubling, frustrating situation for all of us, and we need for all Americans to pull together in the weeks to come to meet this challenge head-on." The CDC said another 8.2 million doses will be shipped to high-need areas after the initial 14.2 million doses are distributed.
CDC spokeswoman Christine Pearson said that the amount of vaccine varies each year. There were 77 million units produced in 1999 and there were about 100 million expected this year. While the CDC consults about annual production volumes with the drugmakers, "in the end, it's their decision," she said.
Last Tuesday, Chiron Corp., based in Emeryville, Calif., notified the Atlanta-based CDC that none of its Fluvirin influenza vaccine would be available for distribution in the U.S. after authorities in the United Kingdom suspended the license to manufacture the drug at its Liverpool plant.
Pearson said the U.S. was expecting Chiron to produce 47 million to 48 million doses, nearly half the U.S. supply, while Aventis was to produce 54 million units, of which, somewhere around 31 million have already be distributed. The announcement today referred to the controlled distribution of the remainder of Aventis's production this flu season.
The CDC, in conjunction with state and local public health officials, will be mapping locations of stocks of the vaccine, concentrations of vulnerable populations and outbreaks of the virus, which are now only sporadic this early in the season, she said.
CDC priority groups for vaccination with inactivated influenza vaccine are:
- all children aged 6-23 months
- adults aged 65 years and older
- people aged 2-64 years with underlying chronic medical conditions
- all women who will be pregnant during influenza season
- residents of nursing homes and long-term-care facilities
- children 6 months to 18 years of age on chronic aspirin therapy
- healthcare workers with direct patient care
- out-of-home caregivers and household contacts of children aged less than 6 months
Aventis Pasteur, which has a U.S. manufacturing plant in Swiftwater, Penn., is the vaccine manufacturing unit of French pharmaceutical giant Aventis, headquartered in Strausbourg.
Meanwhile, drugmaker GlaxoSmithKline is in talks with the Food and Drug Administration about selling its Fluarix influenza vaccine in the U.S. 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 with the Chiron closing 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."
FDA spokeswoman Lenore Gelb declined comment, saying the agency wouldn't comment on any talks with manufacturers.
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 Glaxo introduced Fluarix in 1992, it didn't sell it in the United States because the U.S. market already was "well-served" by five to 10 other manufacturers, Halstrom said.
Now 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., which has a plant in Swiftwater.
"It has become clear to us that this is a market we should serve," Halstrom said.
The Associated Press contributed to this story.