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Health Canada, the regulatory agency responsible for helping Canadians maintain and improve their health, announced its decision approving the COVID-19 vaccine developed by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX).

Pfizer submitted its application for the use of its COVID-19 vaccine on October 9. The pharmaceutical company included in its submission the efficacy, immunogenicity, and safety data from its two ongoing clinical trials and a Risk Management Plan (RMP) for the Pfizer-BioNTech COVID-19 vaccine.

Health Canada performed a thorough and independent review of the evidence supporting the Pfizer-BioNTech COVID-19 vaccine’s efficacy, immunogenicity, and safety.

After two months, the Canadian regulator concluded that the vaccine is safe effective to prevent COVID-19 disease in individuals 16 years of age and older.

“In conclusion, the data provided support favorably the efficacy of Pfizer-BioNTech COVID-19 Vaccine as well as its safety. The efficacy of the vaccine was established to be approximately 95%, the vaccine was well tolerated by participants and has no important safety concerns. The benefit to risk assessment for Pfizer-BioNTech COVID-19 Vaccine is considered favorable.

Pfizer-BioNTech COVID-19 Vaccine is therefore recommended for authorization for use under the Interim order respecting the importation, sale, and advertising of drugs for use in relation to COVID-19, for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older,” wrote Health Canada in its Regulatory Decision Summary for the Pfizer-BioNTech COVID-19 vaccine.

In a statement, Health Canada assured that “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. 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 regulator required Pfizer to continue providing information on the safety, efficacy, and quality of the vaccine as part of the terms and conditions of the authorization given to the pharmaceutical company.

Pfizer and BioNTech are conducting additional clinical trials on children of all age groups.

Yesterday, the United Kingdom started its COVID-19 mass vaccination program, in which a 90-year-old woman named Margaret Keenan became the world’s first person to receive the Pfizer-BioNTech COVID-19 vaccine.  The British government was the first to grant an emergency use authorization for the vaccine.