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.
