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Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5

2022.08.23 23:54

Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5
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.

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