On Mar. 26, 2021, Pfizer and BioNTech announced that the European Medicines Agency (EMA) approved storage of COMIRNATY at -25ﾰC to -15ﾰC for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

With this approval, the COMIRNATY vials can be stored in all 27 European Union (EU) member states at these updated temperatures for a total of two weeks alternatively to the storage at ultra-low temperatures. It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. By enabling more individuals to store and administer the vaccine, the approval will help broaden access, while limiting strain on larger vaccination centers.

The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.