Canada is the third country after the United Kingdom and Bahrain to give the green light to the Pfizer-BioNTech vaccine.
Canada has a temporary accelerated drug review system very similar to the US Food and Drug Administration’s emergency use authorizations.
“The approval of the vaccine is supported by evidence that it is safe, effective and of good quality,” regulator Health Canada said in a statement. It has initially been authorized for use in people 16 years of age or older.
The news comes a day before a panel of advisers to the FDA is set to review and recommend whether the US agency should authorize use of the Pfizer vaccine, and a day after UK citizens become the first in the world to get the shots outside of clinical trials.
Canada will receive an early shipment of up to 249,000 doses of Pfizer’s vaccine this year. The province of Saskatchewan said on Wednesday it expected to receive enough doses for 1,950 people by Tuesday to inoculate healthcare workers in direct contact with COVID-19 patients.
“Today’s decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada,” said Cole Pinnow, president of Pfizer Canada, in a statement.
The UK, on Dec 2, was first to approve the two-dose Pfizer vaccine, which in a large clinical trial was 95% effective at preventing illness.
Pfizer is responsible for shipping its vaccine, which requires ultra-cold storage, to warehouses across Canada.
Canada has a firm order for 20 million doses of the vaccine, enough to inoculate 10 million people, with options to buy up to 56 million more.
For the most part, provincial and territorial health systems will administer the shot, for free, across the country. They will have final say over how to use scarce early supplies in their jurisdictions.
According to preliminary guidance published by the federal government in early November, vulnerable people and those who look after them are high priority, including long-term care residents and some healthcare workers.
Regulators have received rolling applications for three other experimental vaccines, from Moderna Inc, AstraZeneca Plc and Johnson & Johnson.
Of those, the Moderna vaccine is farthest along, having completed pivotal trials showing it to be 94.1% effective at preventing illness and 100% at preventing severe COVID-19.
Officials have said they expect to receive six million doses of Pfizer and Moderna vaccines before the end of March 2021. Each vaccine requires two doses given about three weeks apart.