Moderna Inc said on Tuesday it has completed its submission to the US Food and Drug Administration for the emergency use authorisation 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 US authorisation 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.
Published 23 August 2022, 20:38 IST