Moderna Completes EUA Application for Omicron-Targeting Bivalent COVID-19 Booster

Moderna has completed its Emergency Use Authorization (EUA) submission to the FDA for its COVID-19 booster vaccine targeting the BA.4 and BA.5 strains of the Omicron variant.

The application is intended for authorization of a booster dose in adults 18 years and older.

The application was supported by preclinical and clinical trial data from a phase 2/3 study evaluating the company’s BA.1 Omicron-targeting bivalent booster candidate.

The updated booster shot may offer broader and more durable protection against COVID-19 compared to the currently authorized booster, the company said.