New ammunition for the flu

The federal government has announced a new 10-year pandemic flu vaccine contract with GlaxoSmithKline, valued at more than $425 million, as well as a deal with a backup supplier, Sanofi Pasteur.

TORONTO — The federal government has announced a new 10-year pandemic flu vaccine contract with GlaxoSmithKline, valued at more than $425 million, as well as a deal with a backup supplier, Sanofi Pasteur.

The contracts are intended to ensure a secure supply of vaccine for Canadians in the event of a future influenza pandemic and to reduce the possibility of delays in delivery and distribution.

“Vaccine production is fickle,” said Dr. John Spika, director general of the centre for immunization and respiratory infectious diseases at the Public Health Agency of Canada. “You never know when something could happen, so just from a supply standpoint it’s always nice to know that you have another supply to turn to if problems should arise.”

The long-term contract is required to be with a domestic supplier. If needed, GSK would produce the pandemic vaccine at the company’s facility in Ste-Foy, Que. The deal is for a minimum of 15 million doses a month, Spika said from Ottawa.

The domestic requirement came about because of a swine flu scare in 1976, when the United States refused to allow the export of vaccine destined for Canada. The government didn’t want to get stuck again.

“Canada was the first country back in 2001 to put in place a pandemic vaccine supply, have an overall strategy,” Spika noted.

That came in handy when the H1N1 pandemic flu strain emerged in Mexico and California in 2009, and quickly spread in Canada. But there was a period in the fall of that year when it appeared that the pandemic vaccine wasn’t rolling off the production line quickly enough to meet demand. There were long lineups at flu clinics in a number of cities.

“Being the first country, we didn’t do it perfectly, but I think we’ve really learned, and I think these new contracts give us a number of added advantages,” Spika said.

In a statement, GSK said it looks forward to continuing its long-standing partnership with the various levels of government in Canada in supplying annual flu vaccine and for pandemic preparedness.

“We continue to work together with the government of Canada to evaluate opportunities to expand capacity to handle surges in demand that will enhance Canada’s pandemic preparedness.”

The most notable new element in this pandemic announcement is the three-year deal with Sanofi Pasteur Ltd. of Toronto to provide access to a back-up supply of pandemic vaccine if needed.

That contract is worth just over $33 million and would provide an alternate source of vaccine to treat vulnerable populations, such as pregnant women and those suffering from chronic diseases.

The vaccine provided by Sanofi Pasteur would be manufactured outside Canada.

“In that situation, then, there are always the potential risks for embargoes of vaccine,” Spika said. “But in this particular case, given that it is Sanofi Pasteur, they would actually be bottling the stuff at their Toronto facilities — so at least part of the production process would be on Canadian soil.”

The government said the two contracts, along with a three-year deal with Novartis worth almost $50 million, will also provide the provinces and territories with seasonal flu vaccine for their annual flu shot campaigns. It’s the first seasonal flu vaccine contract with Novartis, which received licensure for the products in Canada within the past 12 months, Spika said.

“If you look back over the last 10 years, it’s really been Sanofi and GSK, so this is a nice opportunity as well, because we now have another vaccine manufacturer that’s providing us with the seasonal vaccine,” he said.

Novartis has a vaccine for the elderly with adjuvant — an agent that stimulates or increases the immune system’s response. It has been used extensively in Europe since the late 1990s, Spika said.

The GSK and Sanofi seasonal flu vaccines are non-adjuvanted.

“But Sanofi, in addition, has this intradermal vaccine for the elderly that’s been licensed here in Canada, and it gives us an opportunity to check it out,” Spika said.

“Normally vaccines use a longer needle and it’s injected through the skin into either the subcutaneous tissue, or into the muscle to get the response. The intradermal route is basically just into the skin itself, and that allows you to use a smaller quantity of vaccine,” he explained. “It’s a way that looks like it may give a better immune response in the elderly, but we need to check that out.”

All three manufacturers are providing Canada with seasonal flu vaccines produced in fertilized hens’ eggs, but newer technologies may be on the horizon.

There’s promise in what’s being called the DNA vaccines, Spika said.

“You can potentially knock a couple of months off the production time, and there are a number of DNA vaccines that are being worked on where, in effect, instead of having to grow the virus in another media — be it fertilized hens’ eggs or cell cultures — you actually insert the genome into another organism to have that organism produce the virus, the vaccine.”

Switching to new technologies of production isn’t in the new flu contracts, but Spika said the agency would be “more than willing to consider that” if advances are made in the coming years.

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