Canada's health regulator has approved the country's H1N1 influenza vaccine, The Globe and Mail has learned.
It will now be moved out of provincial and territorial warehouses and sent to local public health authorities so they can begin immunizing the population as soon as possible.
The authorization by Health Canada will be announced at a news conference later today and will mark the beginning of the country's largest immunization campaign, a federal official has confirmed.
In areas such as Northwest Territories and British Columbia, which have started seeing widespread H1N1 activity, the news of the approval will be particularly welcome. Kami Kandola, NWT's chief public health officer, said in an interview earlier this week that the move by Health Canada will mean officials there can start immunizing as early as Monday. The territory has about 34,000 doses of vaccine that were shipped to it by GlaxoSmithKline. Canada has ordered 50 million doses from the vaccine manufacturer, which has a plant in Ste-Foy, Que., for all Canadians who need and want it.
"We have immunization action teams that are here and waiting. So once we get the regulator to give final authorization, then we will start to repackage the vaccines, ship them out to the communities and we will be ready to go by Monday in some communities," Dr. Kandola said.
Other countries, including the United States, Australia and China, have already begun offering the vaccine to their citizens. Britain launched a mass vaccination program today to prevent further spread of swine flu.
It will become clear today how many doses Canadians will require for immunity. It is assumed that adults will only need one dose. But young children may need two, similar to seasonal flu shots.
What is particularly troubling is that H1N1 disproportionately affects younger people, unlike seasonal flu, which burdens the elderly. That's because the virus resembles a strain of flu that circulated before 1957, to which older people have been exposed.
Canada's vaccine contains an adjuvant, chemical boosters that can increase production and can also provide immunity if the virus mutates. Adjuvant has not been used in influenza vaccines in Canada before. But components of the vaccine have been proven safe: The adjuvant has been tested on thousands with the H5N1 avian flu drug, and the antigen has been tested in other trials in the United States and elsewhere.
The federal government ordered a small amount of non-adjuvanted vaccine for pregnant women and young children because there was no clinical data about the effects of the adjuvant on expectant mothers. It remains unclear when this vaccine will be ready, and there are mixed messages from public health authorities around whether pregnant women should wait for the non-adjuvanted vaccine.
Health Canada's approval is based on GSK's clinical trials in Europe. Canadian clinical trials are just getting under way and the results of those won't be known until late November or early December. Drugs, including vaccines, are routinely approved in Canada without domestic clinical trials.
The swine flu virus mysteriously appeared more than six months ago. Scientists noticed it spreading through Mexico. The virus extended its reach, moving quickly around the globe.
The World Health Organization declared it a pandemic in June.
Caroline Alphonso