(Reuters) – The U.S. Food and Drug Administration plans to approve a request by Pfizer Inc and BioNTech SE to store their COVID-19 vaccine at normal freezer temperatures instead in extreme cold conditions, the New York Times reported. reported Tuesday.
The FDA is expected to release the new guidance to providers as early as Tuesday, amending documents related to the emergency use authority previously issued for the vaccine, an NYT report said, citing familiar people on the case.
Last week, the companies said they had asked the U.S. health regulator to meet the requirements for storing their COVID-19 vaccine at ultra-low temperatures, allowing it to be kept in store freezers medicines.
In December, the FDA approved emergency use of the vaccine and storing the standard label at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), requiring it to be placed in specially designed containers .
On Monday, the U.S. drug dealer said it expects to deliver more than 13 million doses of the combined burn each week to the United States by mid-March, more than doubling the shipment from the United States. 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.
Reporting by Mrinalika Roy in Bengaluru; Edited by Shailesh Kuber and Amy Caren Daniel