Health Canada has approved the Pfizer-BioNTech COVID-19 vaccine—the first to receive authorization in the country.
The regulatory approval means federal officials will start distributing 249,000 doses this month. The shots are part of a deal that includes 20 million doses of the two-dose vaccine, with the option to buy 56 million more.
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” the agency said in a statement today (December 9). “Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.”
Regulators received the vaccine candidate on October 9 and spent two months reviewing data.
Canada is the third country in the world to approve the Pfizer vaccine after the United Kingdom and Bahrain.
The approval comes as Ontario, Quebec, Alberta, and Manitoba grapple with surging cases of the virus ahead of the Christmas holidays.
Health Canada is reviewing three other vaccine candidates, including one from Moderna.
The Pfizer vaccine has been approved for people age 16 and older.
“Pfizer-BioNTech are running further clinical trials on children of all age groups and the indication could be revised in the future to include children if the data from these studies support it,” the regulator said.
Health Canada said the vaccine was 95 per cent effective beginning one week after the second dose.
“This means that people may not be protected against COVID-19 disease until at least seven days after the second dose,” the regulator said.
The Pfizer-BioNTech clinical trials involved about 44,000 participants.
Federal officials will distribute initial doses of the vaccine to 14 distribution depots across the country. Provinces will receive shots on a per capita basis, with Ontario expected to receive around 90,000 from the initial shipment.
B.C. Premier John Horgan and Dr. Ross Brown will join provincial health officer Dr. Bonnie Henry and Health Minister Adrian Dix at the B.C. COVID-19 briefing today to provide details about vaccinations in the province.
With files from Craig Takeuchi.