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Bird Flu News---April 3, 2006

Ottawa puts flu vaccine on fast track

TORONTO - Federal officials are in talks with pharmaceutical giant GlaxoSmithKline to sharply cut the time it would take to vaccinate all Canadians in the event of a bird flu pandemic. That means securing additional vaccine production capacity.

"We want as much as we can as fast as we can," says Dr. Arlene King, director general of pandemic preparedness with the Public Health Agency of Canada.

Federal pandemic planners are now aiming to provide all Canadians who want vaccine with two doses each within two months, once an effective vaccine can be made -- down from eight months.

Two rounds of between 25 million and 30 million doses will be needed to do the job, they estimate.

The previous strategy, outlined in the Canadian pandemic plan, calculated it would take four months to vaccinate every Canadian just once.

Research has since shown two shots -- a primer and a booster -- will likely be needed to protect against a pandemic flu strain.

To meet the new target, the federal government is negotiating with GSK in a bid to lock up more of its expanding Quebec-based vaccine production capacity for Canada.

"We are looking to harness as much capacity as we can to vaccinate the Canadian population -- and as fast as possible. And we're still having discussions with GSK around that," King explains.

The Quebec facilities, which GSK bought last year, are currently undergoing large-scale expansion that will bring production capacity to 75 million doses of seasonal flu vaccine a year in 2007 from roughly 12 million last year.

The government wants to ensure Canadians have first dibs on that added capacity.

"We certainly have the assurance, but discussions are ongoing in order to be able to achieve that and harness that production capacity for Canadians specifically," King says.

"We're very optimistic that we'll be able to work out all of the details related to that."

Other countries are currently shopping around, looking to secure a piece of the world's limited vaccine production capacity in advance of the next pandemic.

"We've been in discussion with virtually every major government ... including the U.S.," David Stout, president of GSK's pharmaceutical operations, admitted in a conference call with journalists last week.

"They're talking to us. In some cases, the governments approached us years ago."

Canada is already first in line for pandemic vaccine produced at GSK's Canadian vaccine facilities, based in Laval and Ste-Foy, Que.

In 2001, the federal government signed a 10-year pandemic vaccine contract with Shire Biologics -- later bought by ID Biomedical, which was sold to GSK last year. The multimillion-dollar contract required the company to be constantly at the ready to make and sell pandemic flu vaccine to Canada.

The made-at-home aspect of the vaccine is critical. Given current vaccine production methods and capacity, global demand will far outstrip global supply during a pandemic. It is expected countries with vaccine plants within their borders may even block exports until domestic needs have been met, regardless of whose order was placed first.

The Canadian contract is considered visionary by many in the international public health world. But the emerging science on pandemic vaccines suggests the initial Canadian order may have been far too small.

Complicating planning is the fact that it's unclear how much antigen or vaccine will be needed for each dose, especially if the worrisome H5N1 avian flu strain triggers a pandemic. That's because H5N1 vaccine doesn't provoke a good immune response.

In a study published last week, U.S. researchers reported it took massive doses -- two shots of 90 micrograms apiece -- to induce what is considered a protective response, and then only in just over half of people who received the largest dose. That's 12 times the vaccine needed to protect against seasonal flu strains.

Additional trials, including by GSK, are trying to find ways to lower the dosing needs by mixing in chemicals called adjuvants that boosts the immune system's reaction to vaccine.

To date, vaccine makers Sanofi Pasteur and Australia's CSL have released limited data from trials of H5N1 vaccine using an adjuvant called alum. Sanofi found two doses of 30 micrograms induced protection, though the company has not yet revealed in what portion of its participants that dose worked. CSL said two doses of 15 micrograms provoked the required immune response in some of its volunteers.

The original Canadian order envisaged eight million doses of 15 micrograms per month over four months. But the clear evidence that two doses would be required would stretch that timeline to eight months.

And if it turns out that each dose must be larger than 15 micrograms, that would further add to the time needed to produce sufficient vaccine, as the contract currently stands.

King said the aim of the current negotiations is to guarantee for Canada "with any dose, whatsoever, enough vaccine to vaccinate all Canadians within a two-month time frame."