Moderna seeks USFDA nod for COVID booster tailored against Omicron subvariants
The submission also includes clinical trial data for its BA.1 Omicron-targeting bivalent booster candidate, which was last week cleared in Britain.;
New Delhi: Moderna Inc on Tuesday sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September.
Its application with the U.S. Food and Drug Administration (USFDA) is based on pre-clinical data for the so-called bivalent dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain.
Moderna said a mid-to-late stage trial for the vaccine is under way.
The submission also includes clinical trial data for its BA.1 Omicron-targeting bivalent booster candidate, which was last week cleared in Britain.
Moderna's 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.
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