(Reuters) – The US Food and Drug Administration intends to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 vaccine at standard freezer temperature, instead of in ultra-cold conditions , the New York Times reported Tuesday.
The FDA is expected to announce the new guidelines to suppliers as early as Tuesday, amending documents related to the emergency use authorization previously granted for the vaccine, the NYT report said, referring to people familiar with the matter. .
Last week, the companies said they had asked the U.S. health regulator to store the requirements for their COVID-19 vaccine at ultra-low temperatures, which could potentially keep them in pharmacy freezers.
In December, the FDA gave permission for emergency use for the vaccine and the current label to be stored at -80 ° C to -60 ° C (-112 ° F to -76 ° F), meaning it is in specially designed containers must be sent.
The U.S. drugmaker said Monday it expects to deliver more than 13 million doses of the jointly developed shot per week to the United States by mid-March, more than doubling.
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; Edited by Shailesh Kuber and Amy Caren Daniel