FDA is said to clear updated COVID shots as early as next week

The U.S. Food and Drug Administration (FDA) is expected to greenlight newly adjusted COVID vaccines as soon as next week, CNN reported, citing two sources familiar with the matter.

The FDA is poised to approve updated messenger-RNA-based vaccines developed by Pfizer (NYSE:PFE)/ BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) targeting the KP.2 strain of the virus, according to the sources.

It is unclear if Novavax (NASDAQ:NVAX), whose updated COVID shot is currently under FDA review, would simultaneously receive regulatory clearance for its protein-based vaccine.

In June, the FDA advised vaccine makers to develop monovalent COVID shots adjusted for the Omicron JN.1 variant for this year’s fall immunization drive.

A potential approval next week will signal an accelerated timeline from the FDA in the authorization process, as the agency cleared the previous crop of COVID-19 shots adjusted for the Omicron XBB.1.5 variant in September 2023.

An FDA spokesperson told CNN that the agency couldn’t comment on marketing applications for the products, but “anticipates taking timely action to authorize or approve updated COVID-19 vaccines in order to make vaccines available this fall.”