Health Canada has approved for use the COVID-19 vaccine produced by Pfizer and BioNTech.
"Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place," read a release from the agency. "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."
The vaccine is approved for those aged 16 and over. Pfizer-BioNTech is still running clinical trials on children.
Health Canada said the vaccine trial involved nearly 20,000 subjects, each of whom was given two shots. Some received the vaccines, while others received a placebo.
"A total of 9,531 and 9,536 subjects (16 years old and older) in the vaccine and placebo group respectively, were followed for at least two months after the second administration," Health Canada said in its report. "The most frequent adverse reactions in a random subset (N=8183) of study participants 18 years of age and older, who received the vaccine and were monitored for reactogenicity were: injection site pain (84.1 per cent), fatigue (62.9 per cent), headache (55.1 per cent), muscle pain (38.3 per cent), chills (31.9 per cent), joint pain (23.6 per cent) and fever (14.2 per cent) and were usually mild or moderate in intensity and resolved within a few days after vaccine administration."
The companies will have to continue to provide information to Health Canada on the safety, efficacy, and quality of the vaccine. Health Canada will also publish documents related to the decision in the coming weeks.
Prime Minister Justin Trudeau said on Monday that, pending approval from Health Canada, the vaccine may start to roll out next week. That is when 249,000 shots are expected in early delivery. In total, the Canadian government purchased 76 million doses of the vaccine.
The government has identified 14 sites across the country where the first doses will be delivered. The four largest provinces, including Ontario, will have two delivery sites.
Canada also has agreements with Moderna, GlaxoSmithKline, Johnson & Johnson, AstraZeneca, Sanofi, and Medicago. Approval for those vaccines has not yet been granted.