FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures: NYT

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

(Reuters) – The US Food and Drug Administration intends to approve a request by Pfizer Inc. and BioNTech SE to keep their COVID-19 vaccine at standard freezer temperatures instead of ultra-cold conditions, the New York Times reported Tuesday.

The FDA is expected to announce new guidelines to suppliers as early as Tuesday, amending documents related to the emergency use permit previously granted for the vaccine, the NYT report said, citing people familiar with the issue.

Last week, companies said they asked the US health regulator to relax the requirements for the COVID-19 vaccine to be stored at ultra-low temperatures, allowing it to potentially be stored in freezers in pharmacies.

In December, the FDA authorized the emergency use of the current vaccine and label to be stored at temperatures between -80 ° C and -60 ° C (-112 ° F to -76 ° F), which means that it must be transported 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 by mid-March, more than doubling its shipments since early February.

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

Reporting by Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber and Amy Caren Daniel

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