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.
