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


Adds details, background

Aug 23 (Reuters) - Moderna Inc MRNA.O 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 said.

The announcement comes a day after rival Pfizer Inc PFE.N and German partner BioNTech BNTX.O 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.

(Reporting by Leroy Leo in Bengaluru; Editing by Arun Koyyur)

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