The FDA will allow the Pfizer-BioNTech vaccine to be stored at a higher temperature: NYT

FILE PHOTO: The syringes are seen in front of the Biontech and Pfizer logos shown in this illustration taken on November 10, 2020. REUTERS / Dado Ruvic / Illustration

(Reuters) – The U.S. Food and Drug Administration plans to approve a request from Pfizer Inc. and BioNTech SE to store the COVID-19 vaccine at standard freezer temperatures instead of in ultra-cold conditions, according to reported the New York Times on Tuesday.

The FDA is expected to announce the new guidance to suppliers as early as Tuesday, modifying documents related to the emergency use authorization previously granted for the vaccine, according to the NYT report, which cites people familiar with the matter.

Last week, companies said they asked the U.S. health regulator to relax the requirements for storing their COVID-19 vaccine at extremely low temperatures, which could allow its preservation in pharmacy freezers.

In December, the FDA granted emergency authorization for the vaccine and the current label to store them at temperatures between -80 ºC and -60 ºC (-112 ºF to -76 ºF), which which means it must be shipped in specially designed containers.

On Monday, the US drug maker said it expects to deliver more than 13 million doses of the jointly developed shot a week to the United States in mid-March, rather than double its shipments in early February.

The U.S. health agency declined to comment on the report, while Pfizer did not immediately respond to Reuters’ request for comment.

Reports from Mrinalika Roy to Bengaluru; Edited by Shailesh Kuber and Amy Caren Daniel

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