(Reuters) – The US Food & Drug Administration plans to approve the order by Pfizer Inc and BioNTech SE to store its COVID-19 vaccine in standard freezer temperatures, rather than in ultra-cold conditions, the New York Times reported Tuesday. market.
The FDA is expected to announce the new guidance to providers as early as Tuesday, modifying documents related to the emergency use authorization that was previously granted for the vaccine, the NYT report said, citing people familiar with the matter.
Last week, companies said they asked the U.S. health regulator to relax the requirements for their COVID-19 vaccine to be stored in ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers.
In December, the FDA granted emergency use authorization for the vaccine and the current label to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), which means it must be shipped in specially designed containers.
On Monday, the American drugmaker said it expects to deliver more than 13 million doses of the jointly developed vaccine each week to the United States by mid-March, more than doubling 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.
Reporting by Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber and Amy Caren Daniel