Flu Shot Options Explored

(CBS/AP)  Many of the nation's scarce remaining flu shots will be shipped directly to pediatricians, nursing homes and other places that care for high-risk patients, under a plan negotiated between the government and maker Aventis Pasteur.

Meanwhile, pharmaceutical giant GlaxoSmithKline 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. had to shutter its vaccine plant in England last week because of concerns over contamination.

The targeted shipments by Aventis come as health officials struggle to ensure the people who most need flu shots get them, now that the nation's supply of influenza vaccine has been slashed in half.

Under the plan announced Tuesday by the Centers for Disease Control and Prevention, Aventis will direct shipments of its remaining 22.4 million doses to health workers who care for patients that the CDC deems at highest risk of death or hospitalization from influenza.

The first of the shipments, about 14.2 million doses, begins immediately but will take six to eight weeks to finish distributing to pediatricians' offices, hospitals, nursing homes and long-term care facilities that thus far haven't received much, if any, vaccine.

Also, the CDC is mapping county-by-county the number of flu vaccine doses shipped and matching that with each county's number of high-risk residents — to direct Aventis' next shipments even more tightly.

Glaxo currently only has about 500,000 doses of Fluarix 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 CDC last week urged healthy adults to forego getting flu shots, after British regulators unexpectedly shut down Chiron.

That left Aventis as this year's sole supplier of injectable flu vaccine, with a total 55.4 million doses. By last week, it had shipped over half that amount, mostly to private distributors — and the CDC asked doctors, grocery stores and other flu-shot venues to enforce the voluntary rationing and stretch the supply.

The CDC hopes the new plan for allocating the rest of Aventis' supply can better target the shots to the highest-priority patients: babies and toddlers ages 6 months to 23 months; anyone 65 or older; anyone with chronic medical conditions such as heart or lung disease; pregnant women; residents of long-term care facilities; children on chronic aspirin therapy; health workers who care for high-risk patients; and caregivers and household contacts of babies under age 6 months.

Flu shots are made of killed influenza virus. The healthy do have a limited other option: the nasal spray vaccine FluMist, made of live but weakened virus. Maker MedImmune Inc. said last week it would double supplies to 2 million doses. It is to be used only by healthy 5- to 49-year-olds.