Canadian Manufacturing

Health Canada allows more flexible storage and transportation conditions for Pfizer-BioNTech COVID-19 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 to the recommended storage condition of -80°C to -60°C

March 4, 2021  by CM Staff

First Mobile Hybrid Container Solution made by MECOTEC with an active deep cooling technology for transport, storage and distribution of COVID-19-Vaccines down to – 80°C / -112 °F. (PRNewsfoto/MECOTEC GmbH)

OTTAWA — 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 Feb. 25, from Pfizer-BioNTech, to change the storage conditions of its vaccine.

On Dec. 9, 2020, Health Canada authorized the Pfizer-BioNTech vaccine after an independent review which determined that this vaccine meets the Department’s safety requirements. At that time, the Department authorized the vaccine to be stored at temperatures between -80ºC and -60ºC.

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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.

The authorization of this change is consistent with decisions made by other foreign regulators, such as the U.S. Food and Drug Administration.