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

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.

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 said.

The announcement comes a day after rival Pfizer Inc 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.