Moderna completes application seeking FDA nod for updated COVID shot
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Moderna (NASDAQ:MRNA) announced on Tuesday that the company completed submissions to the FDA for U.S. emergency use authorization (EUA) of its Omicron targeting bivalent COVID-19 booster vaccine candidate mRNA-1273.222.
Unlike its FDA-authorized COVID-19 booster, mRNA-1273.222 is designed to target the original strain of the virus and the BA.4/BA.5 subvariants of the Omicron strain.

The company's application includes preclinical data for mRNA-1273.222 and Phase 2/3 clinical trial data for mRNA-1273.214, another bivalent booster candidate targeted at Omicron BA.1 subvariant.
Moderna (MRNA) says mRNA-1273.214 met the study's main goals while indicating strong neutralizing antibody responses against BA.4 and BA.5 compared to its currently authorized booster shot mRNA-1273.
The company has ramped up the production of mRNA-1273.222, for which a Phase 2/3 trial is currently underway, to deliver doses in September subject to FDA authorization.
In June, U.S. COVID vaccine developers received guidance from the FDA to update their vaccines to protect against BA.4/BA.5 subvariants and the original COVID strain.