FDA approves 1.2 million doses of flu vaccine from Germany for U.S.
Health and Human Services Secretary Tommy Thompson said Tuesday that the Food and Drug Administration has authorized 1.2 million doses of flu vaccine manufactured in Germany for use in the United States. And more additional doses may be announced in the coming weeks, officials said.
The drugs, which are expected to be available this month, will add to the current supply of 61 million doses of vaccine. Thompson said an additional company has agreed to make up to 4 million doses of the vaccine available.
The new product is already used in 30 countries, though not in the U.S. because its makers have not applied for approval. The vaccine will be made available in this country under an investigational new drug application. It was manufactured in GlaxoSmithKline's Germany plant, which the FDA has inspected, Thompson said.
According to the FDA, U.S. health officials are attempting to get more suppliers to enter the U.S. market to boost this year's suppliers. Two companies said this week that they want to enter the U.S. market with one entering as early as next flu season and the other entering as late as 2007.
A vaccine shortage became apparent in October after contamination problems beset the Chiron Corp. plant in England, one of two major suppliers to the U.S. market. Although the flu season generally has gotten off to a mild start, healthcare professionals remain concerned. Flu season typically peaks in January.