Pfizer Asks FDA to Approve Storage of COVID Vaccine in Standard Freezers

Alicia Ault

February 19, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Pfizer and BioNTech have submitted data to the US Food and Drug Administration (FDA) demonstrating that their COVID-19 vaccine can be safely stored at temperatures commonly found in pharmaceutical freezers and refrigerators.

The data show that the vaccine is stable when stored at -25° C to -15° C (-13° F to 5° F), the two companies said in a statement. Vaccines are typically stored at those temperatures, according to the Centers for Disease Control and Prevention (CDC).

Pfizer Chairman and CEO Albert Bourla said the two companies had been continuously exploring how to produce a vaccine that would be more accessible to a variety of administration sites. The FDA will review the data and determine whether the Pfizer/BioNTech vaccine label can be changed. Currently, the label states that the vaccine must be stored at temperatures from -80° C to -60° C (-112° F to -76° F).

The companies are seeking to change the label to allow an option to store the vaccine for 2 weeks at -25° C to -15° C (-13° F to 5° F). The Moderna vaccine, which is the only other COVID-19 vaccine with an FDA emergency use authorization, is shipped and stored at those temperatures, according to the CDC.

"If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply," said Bourla in the statement.

As of now, the Pfizer/BioNTech vaccine must be shipped in special containers that have to be repacked with dry ice every 5 days if the container will be used as a primary storage unit. That unit can only be used for up to 30 days. The vaccine can otherwise be stored at the ultracold temperatures for up to 6 months.

Currently, the Pfizer/BioNTech vaccine also can be stored in a standard refrigerator (from 2° C to 8° C) for up to 5 days, after which it can be administered at room temperature.

Although it's more difficult to ship and store the Pfizer vaccine, it has been administered to more Americans, in part because it was the first to receive emergency authorization.

According to the CDC's COVID Data Tracker, 29.5 million Pfizer/BioNTech vaccines have been administered, and 28 million Moderna vaccines have been given.

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