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Fears That Countries Would Hoard Vaccine in Pandemics Behind Single Supplier Decision in Canada

Thu, 11/05/2009 - 4:00am
Helen Branswell Medical Reporter Canadian Press TORONTO — Fears that countries would close borders to key pharmaceutical exports in a pandemic drove Canada's decision to award its pandemic flu vaccine contract to the only company that makes the product in this country, people who were involved in pandemic planning at the time say. The need for a made-in-Canada vaccine supply was considered paramount to those doing the planning; they had already seen access to limited global supplies of vaccine and drugs dry up during two previous pandemic scares. "There are very few flu (vaccine) manufacturers in the world. The big ones are just in a few countries. And so there was concern about any of those countries wanting to restrict export of their vaccine," says Dr. Susan Tamblyn, considered by some the mother of Canada's pandemic plan and a long-time fixture in international pandemic preparedness efforts. Canada pioneered the now-widely used system of advance purchase agreements for pandemic vaccine when the then government of Prime Minister Jean Chretien signed the pandemic vaccine contract in 2001. The 10-year contract, worth then $323,522,500, was awarded to Shire BioChem, a British company that had a flu vaccine manufacturing plant outside Quebec City. The contract went with the plant when it was sold in 2004 to ID Biomedical and in 2005 to GlaxoSmithKline. As part of the contract, Shire was guaranteed 75 per cent of Canada's seasonal flu vaccine purchase. The $323 million figure included the cost of the annual seasonal flu vaccine. The move angered vaccine giant Sanofi Pasteur, which used to share Canada's market 50-50 with Shire. But Sanofi does not have flu vaccine production capacity in Canada. Under the contract, Shire was required to maintain a constant supply of enough eggs to make pandemic vaccine whenever the need arose. At the time manufacturers didn't need and didn't keep a year-round supply of eggs. The contract was the envy of many countries and was quickly emulated. The United States, for instance, signed advance purchase agreements with five companies, though most of the U.S. supply is made offshore. "We got sort of two types of reactions, I think, when we first announced this," says Tamblyn, who is retired but still serves as an occasional consultant to the Public Health Agency of Canada. "One was that it was very visionary — and that was definitely recognized. The other was just a little bit of concern." The concern, she says, related to the fact that the move put out into the open something other countries knew but didn't want to acknowledge — if a pandemic broke out, borders would probably close to key pharmaceutical exports. It had happened before. In 1976, during the infamous swine flu scare, the U.S. would not allow exports of swine flu vaccine. Canada's supplier at the time was U.S.-based and Canada's delivery did not come. Eventually, Canada managed to buy some vaccine from Australian manufacturer CSL, because Australia did not plan a mass vaccination program. In 1997, global supplies of antiviral drugs evaporated overnight when it was discovered a bird flu virus — H5N1 — had infected a number of children. It had previously been thought bird viruses could not infect humans without adapting first in an intermediary animal like a pig. The world thought it was on the brink of a deadly pandemic. There were only two antiviral drugs on the market at the time, amantadine and rimantadine, and suddenly they couldn't be bought for love nor money. "The world supply just disappeared overnight," Tamblyn says. "A few countries grabbed for themselves. They placed immediate orders." "The parallel there would be that one would expect the same thing to happen with vaccine." Chief Public Health Officer Dr. David Butler-Jones has recently said Canada would probably look at diversifying its supply base when the pandemic contract expires in 2011. But more suppliers doesn't guarantee better supply with notoriously finicky flu vaccine, says Dr. Marie-Paule Kieny, head of the World Health Organization's vaccine research initiative. "All the manufacturers have had delays. And some countries have two, three or one and they are also having delays," Kieny notes. "So you might have had more than one manufacturer but not have more vaccine available to start with." "This is not a GSK Canada problem. The production yield is a problem with all the manufacturers." And flu expert Dr. Allison McGeer says there was probably discussion about getting a back-up supplier after one of the manufacturers, Chiron (now owned by Novartis) failed to deliver more than 40 million doses of seasonal flu vaccine to the U.S. in 2004 because of a contamination problem. But Canada was already spending a lot of money on one pandemic contract and there was no way of knowing if a pandemic would even occur in the life of the contract. Besides, McGeer says, there remained the issue that vaccine made outside of Canada couldn't be counted on. "People might have felt that having vaccine production that was out of the country, that kind of contract might not be worth much during a pandemic," says McGeer, head of infection control at Toronto's Mount Sinai Hospital. "I mean it's fine in this pandemic, people probably would have honoured it. But in other pandemics, it might not have (been). If vaccine was being produced in the U.S. or France, it might not have mattered that we had a contract."
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