Health Canada approves the use of Pfizer-BioNTech COVID-19 vaccine

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COVID-19 vaccine booster shots
Image source: FDA

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.