British regulators have extended their suspension of Chiron Corp.'s license to manufacture flu vaccine, jeopardizing the company's ability to sell millions of flu shots in the United States next flu season.
The extended suspension announced late Tuesday means that Chiron, already blocked from shipping 48 million shots to the United States this year, may not be able to resume operations until at least April, a month after the company has indicated it needs to start production for the season that will begin next fall.
Flu Crisis Sparks Fresh Look at Vaccine Production (The Washington Post, Nov 27, 2004)
U.S. Knew Last Year of Flu Vaccine Plant's Woes (The Washington Post, Nov 18, 2004)
CDC Announces Plan To Ration Flu Vaccine (The Washington Post, Nov 10, 2004)
Canada's Vaccine Plan May Be Model for U.S. (The Washington Post, Oct 25, 2004)
MedImmune to Produce Additional Flu Vaccine (The Washington Post, Oct 22, 2004)
"That's a clearly worrisome development," said Walter Orenstein, former director of the National Immunization Program at the Centers for Disease Control and Prevention.
But continuing problems at California-based Chiron, which produces its vaccine in Great Britain, may be outweighed by the prospect that other companies from abroad will seek -- and win -- U.S. approval to sell their vaccines in the future.
On Tuesday, the Bush administration gave emergency approval for GlaxoSmithKline PLC to sell its German-made vaccine this season. The administration said it will purchase 1.2 million doses, and the company said it could provide an additional 2.8 million doses if needed.
GlaxoSmithKline, based in London, said yesterday that it is seeking priority review from the Food and Drug Administration for a permanent license beginning next flu season. If it wins approval, Glaxo intends to sell between 10 million and 20 million doses and could produce many more, said Patty Seif, a company spokeswoman.
ID Biomedical Corp. of Vancouver said it also will seek a priority review for next year. Executives said they could produce at least 10 million doses for the U.S. market. But the company acknowledged that approval might not come until 2007, as expected before this year's vaccine shortage. This week, ID Biomedical backed away from a plan to offer 1.2 million doses to the United States this season, reserving them for the Canadian government's stockpile.
Aventis Pasteur, the nation's only other licensed flu shot provider, said yesterday that it could produce as many as 60 million doses, up from the 50 million it originally planned for this season and the 58 million it was able to provide after the shortage emerged.
The interest of Glaxo and ID Biomedical in jumping into the U.S. flu vaccine market may have been heightened by the federal government's response to the shortage, Orenstein said.
He noted the government's increased willingness to buy unused flu shots, potentially stabilizing the market and reducing risk. Federal health officials persuaded Congress to earmark $100 million for a government effort to buy up unused vaccine next year. The money is in the omnibus spending bill that President Bush signed yesterday.