Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5
2022.08.23 23:54
FILE PHOTO: Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken November 27, 2021. REUTERS/Dado Ruvic/Illustration//
(Reuters) -Moderna Inc said on Tuesday it has completed its submission to the U.S. Food and Drug Administration for the emergency use authorization of its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron.
The application is based on pre-clinical data for the dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain.
The submission also includes clinical trial data for its BA.1 Omicron-targeting bivalent booster candidate, Moderna (NASDAQ:MRNA) said.
The announcement comes a day after rival Pfizer Inc (NYSE:PFE) and German partner BioNTech sought U.S. authorization for their vaccine booster retooled to target the BA.4/BA.5 subvariants of Omicron.
Pfizer also said they would have doses available to ship immediately after regulatory clearance.
