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Pfizer submits data to FDA showing vaccine can be stored at higher temperatures

Company hopes FDA will update prescribing information
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Posted at 10:10 AM, Feb 19, 2021
and last updated 2021-02-19 10:11:28-05

NEW YORK, N.Y. — Pfizer and BioNTech announced Friday that they’re submitting new data to the Food and Drug Administration (FDA) that shows their COVID-19 vaccine can be stored at higher temperatures, which could help make the distribution process easier.

Pfizer says data demonstrates its vaccine can remain stable when stored at -13°F to 5°F, temperatures more commonly found in pharmaceutical freezers and refrigerators.

Currently, the Centers for Disease Control and Prevention (CDC) says the Pfizer vaccine must be stored in an ultra-cold freezer between -112°F and -76°F. The vials can remain stored at these temperatures for up to six months.

By submitting this data to the FDA, Pfizer hopes the FDA will update its emergency use authorization prescribing information, which would allow for vials to be stored at the lower temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.

As additional stability data is obtained, Pfizer says it anticipates the shelf life and/or expiration date of its vaccines could be extended, and alternate short-term temperature storage may be considered.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,” wrote Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

The same data will be submitted to other regulatory agencies around the world within the next few weeks, according to Pfizer.