17 October 2004

Canadian company poised to provide U.S. its flu shots

Toronto -- Tony Holler thinks there's still an even chance U.S. regulatory authorities will find a way to import his company's surplus influenza vaccine to help fill a gaping void created by the unexpected loss of half the U.S. annual supply of flu shots.

Mr. Holler, president of Vancouver-based ID Biomedical, says there is serious interest among U.S. regulators in figuring out how to legally purchase flu vaccine from companies not currently licensed to sell in that country.

"I would say it's kind of 50-50 as to how this is all going to work for us," Mr. Holler said.

"There's a lot of political will to get this done and U.S. public health will to get this done. But I just think that there's the situation that it's not an approved product and nobody knows how they can get this done.

"I would say that the regulators are working their tails off to try to figure this out themselves. So it's not like they're being in any way obstructionist. But they have a duty to people in the U.S. that products that get used [there] get approved."

The 1.2 million doses ID Biomedical has to sell won't come close to making up the U.S. shortfall. Chiron Corp., the company at the centre of the vaccine debacle, was to have provided between 46-million and 48-million doses to the U.S. market this year.

But public health officials dealing with the nightmare of long lines, panic and public discontent have said even small additional amounts would help ensure more people in the high-risk groups get vaccinated.

During last Wednesday's presidential debate, U.S. President George W. Bush suggested surplus product from Canada might be secured to help with the shortfall of nearly 48-million doses.

The next day, his health secretary, Tommy Thompson, glumly suggested it was unlikely unlicensed vaccine could make it through the regulatory process in time for this flu season.

But late Friday in a news conference, authorities again said they had been scouring the vaccine world looking for available supply.

"We are checking with every known source and every government that we deal with," said Lester Crawford, commissioner of the Food and Drug Administration, as his agency's review of Chiron's operations confirmed the company's product would not be salvaged.

The result of the review raises questions about whether Chiron can get its flu vaccine-making facility in Liverpool, England, up to standard in time to manufacture influenza vaccine for next flu season. The manufacture of flu vaccine takes months to complete.

During Friday's news conference, Dr. Crawford insisted he was optimistic the company would be able to manage that.

But Mr. Holler anticipates U.S. authorities may be seeking additional sources of flu vaccine next winter as well.

"That Chiron situation is not determined. So they could be in the same position next year," he noted.

ID Biomedical, which had planned to seek a U.S. licence in time to sell vaccine there for the 2007 flu season, could ramp up production next year to provide between 10-million and 15- million doses to the U.S. market -- if regulators find a way to let its product in, Mr. Holler said.

"If we can get these 1.2-million doses into the U.S. from ID Biomedical . . . then they'll have figured out a way of getting the larger volume into the U.S. market next year," he said.

Canadian Press

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