Health Canada authorizes more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine

May 19, 2021 | Ottawa, ON | Health Canada

Today, Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored at regular refrigerated temperatures (2-8°C) at the point of use for up to one month. This change means that there will be more storage options available for the Pfizer-BioNTech vaccine, which will allow for more flexibility in distribution plans.

Health Canada received the application from Pfizer-BioNTech to change the storage conditions of its COVID-19 vaccine on May 10, 2021. After conducting a thorough review of the submission, the Department determined that undiluted COVID-19 vaccine remains stable when stored at standard refrigerated temperatures for 31 days.

The vaccine was first authorized with a recommended storage temperature of between -80°C to -60°C (-112°F to -76°F) and thawed undiluted vials could be stored in the refrigerator for only up to 5 days. On March 3, 2021, Health Canada authorized a change to enable storage at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks.

Since the initial authorization of the vaccine, the manufacturer has continued to develop additional, longer-term data on the stability of the product under different conditions. As a result of this research, Pfizer provided additional data to support more flexible storage conditions. This latest change will support additional flexibility in vaccine distribution.

Health Canada will continue to monitor the safety, efficacy and quality of the Pfizer-BioNTech vaccine, along with all other COVID-19 vaccines, and will not hesitate to take action if any concerns are identified.