FDA Finds More Flu Vaccine in Germany, Canada



May 2, 2003
By Maggie Fox, Health and Science Correspondent
Yahoo News

WASHINGTON (Reuters) - Five million additional does of flu vaccine have been located in Germany and Canada and U.S. regulators will try to import them for Americans if they meet U.S. safety standards, Health and Human Services Secretary Tommy Thompson said on Thursday.

The Food and Drug Administration is sending inspectors to the vaccine plants owned by GlaxoSmithKline Plc in Germany and ID Biomedical in Canada to confirm the doses meet U.S. standards, Thompson told a news conference.

"If they find that it is safe, we will import it," Thompson said.

The new doses would bring to about 66 million the number available for the U.S. market for the influenza season just starting -- about two-thirds of the 100 million hoped for before manufacturer Chiron Corp. lost its license due to contamination at its British vaccine plant.

They would be available by mid-December by the latest, in time for the peak of the influenza season, FDA Commissioner Dr. Lester Crawford said.

"We are dispatching the teams next week," Crawford said. "If all goes well, the vaccines will be available within a few weeks."

In addition, Merck and Co. will triple production of its pneumococcal vaccine, given every five years to prevent a nasty form of pneumonia that can develop on its own or along with a flu infection, Thompson and Crawford said.

The flu vaccine issue has become a political hot potato in the United States, with the administration of President Bush saying they have handled the problem well, and Democrats saying the government failed to prepare adequately for the crisis.

Health experts have been warning for years that the United States risked an influenza emergency, pointing out that only three companies now supply the flu vaccine market and that Americans fail to get vaccinated in enough numbers to protect themselves and encourage vaccine makers.

Influenza kills an estimated 36,000 Americans every year and lands 200,000 in the hospital. About 185 million Americans should get vaccinated, the Centers for Disease Control and Prevention says, but last year only 83 million did.

With this year's shortage, the CDC has asked that only high-risk Americans get the shot -- those over 65, babies aged 6 to 23 months, people with chronic illnesses, their caregivers and pregnant women.

Healthy adults and children over 5 can get FluMist, MedImmune's nasal vaccine. MedImmune will make 3 million doses of the vaccine available this year.

Thompson urged Americans who have been standing in line to get flu shots to stop doing so and instead wait until they can be sure of getting a shot.

"About 17 million of the Aventis vaccine is still to come (about 3 million doses a week are being distributed), as well as 2 million doses of FluMist," HHS said in a statement.

"We're redirecting vaccine originally purchased by the government for federal employees and the military to priority populations throughout the country," Thompson added.

"This includes 200,000 doses of vaccine purchased originally for the military, which will now use FluMist, thus freeing up the injectable vaccine for the priority populations who cannot take FluMist."

So far it does not look like the flu season is off to a bad start, said Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Diseases. "At this time, if you compare it to previous years, including last year, it is generally light," Fauci told the news conference.

And the circulating strains of flu match the vaccine, he added. Flu vaccines are re-made each year to match the most common strains of flu and this year's includes both influenza A and influenza B strains.

(Additional reporting by Lisa Richwine)

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