Pfizer, BioNTech Gets EMA Approval for New Covid-19 Vaccine Storage Rules

By Chris Wack

Pfizer Inc. and BioNTech SE said Friday that the European Medicines Agency approved storage of its Covid-19 vaccine at -25 degrees Celsius to -15 degrees for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

The companies said that with the approval, the vaccine vials can be stored in European Union member states at the updated temperatures for two weeks alternatively to the storage at ultra-low temperatures, allowing storage in pharmacies to support vaccinations at local practices/doctors' offices.

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 U.S., U.K., Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 26, 2021 09:47 ET (13:47 GMT)

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