Pfizer-BioNTech COVID-19 vaccine: Authorization information
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Market authorization with conditions
Health Canada authorized the Pfizer-BioNTech COVID-19 mRNA vaccine (Tozinameran or BNT162b2) for use for the COVID-19 pandemic. Authorization followed the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.
Due to the urgent public health needs relating to COVID-19, we can issue a market authorization with conditions to support early access to promising health products when the potential benefits outweigh the potential risks. In December, we published guidance to vaccine manufacturers on the evidence and documentation required to obtain a market authorization for a COVID-19 vaccine under the interim order.
The approval of the vaccine is supported by evidence that it is safe, effective and of high quality. Find detailed technical information about the Pfizer-BioNTech COVID-19 vaccine, such as the product monograph and our regulatory decision summary, in the COVID-19 vaccines and treatments regulatory portal.
According to the terms and conditions that Health Canada placed on the authorization, the manufacturer (Pfizer Canada ULC and BioNTech Manufacturing GmbH) will submit to Health Canada:
- monthly post-market safety monitoring reports, including information about serious and non-serious adverse drug reactions in Canada and abroad
- any further data on the long-term safety and effectiveness of the drug, including final data from ongoing clinical trials
- further quality data confirming that the manufacturing processes and controls will continue to consistently produce a product of suitable quality for the intended use
Risk management plan
Companies are required to submit a risk management plan (RMP) to Health Canada when applying for any marketing authorization.
RMPs include information on:
- a vaccine's safety profile
- how its risks will be prevented or minimized in patients
- plans for studies and other activities to gain more knowledge about the safety and effectiveness of the vaccine
- how the effectiveness of the measures that minimize risk will be determined
Health Canada reviewed the RMP for the Pfizer-BioNTech COVID-19 vaccine and found it to be acceptable.
In addition to working with the Public Health Agency of Canada and provinces and territories, Health Canada also exchanges information with our international regulatory counterparts on an ongoing basis. This collaboration helps to support the review process and post-market safety monitoring activities.
We continue to actively monitor and review all relevant data to determine whether changes to the market authorization of the Pfizer-BioNTech COVID-19 vaccine in Canada are required.
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