MHRA approves longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution

Once removed from the freezer, the undiluted vaccine now has a maximum shelf life of up to 1 month (31 days) when stored in refrigerator at 2°C to 8°C (this was previously 5 days). This extension applies to all existing batches currently in circulation with the UK.

SPS commentary:

The MHRA advises that any boxes already labelled with 120 hours post ultra-low temperature should either be used within that original expiry or provisions made for the expiration date extension under suitable controls. The controls anticipated would be ‘in-line’ with the approach to the controls required for the application of the thaw labels when first applied.

Medicines and Healthcare products Regulatory Agency