March 3, 2021 | Ottawa, ON | Health Canada
Today, Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored and transported at standard freezer temperatures (between -25°C and -15°C) for up to two weeks instead of ultra-cold conditions, facilitating more flexible transportation and local re-distribution of this vaccine.
Vials stored at -25°C to -15°C for up to 2 weeks or transported at -25°C to -15°C may be returned one time to the recommended storage condition of -80°C to -60°C.
This decision follows Health Canada’s receipt of a submission, on February 25, 2021 from Pfizer-BioNTech, to change the storage conditions of its vaccine.
On December 9, 2020, Health Canada authorized the Pfizer-BioNTech vaccine after a thorough, independent review which determined that this vaccine meets the Department’s stringent safety, efficacy and quality requirements. At that time, the Department authorized the vaccine to be stored at temperatures between -80ºC and -60ºC.
While ultra-cold conditions are still recommended for the Pfizer-BioNTech vaccine, after conducting a thorough review of Pfizer-BioNTech’s latest submission, the Department determined that the COVID-19 vaccine remains stable when transported and stored at standard freezer temperatures for up to two weeks. This means the vaccine continues to be safe and effective and meets Health Canada’s quality standards.
This change has been reflected in the vaccine’s Product Monograph, available on Health Canada’s website.
The authorization of this change is consistent with decisions made by other foreign regulators, such as the U.S. Food and Drug Administration.
Health Canada will continue to closely monitor the safety and efficacy associated with this change and will take appropriate action if any concerns are identified.