Moderna finishes FDA application for emergency use authorization of Omicron-specific COVID-19 booster vaccine

Moderna, Inc. announced this week that it has finished its submission to the United States Food and Drug Administration (FDA) seeking emergency use authorization (EUA) for its BA.4/BA.5 Omicron-focused bivalent COVID-19 booster vaccine.

The candidate, or mRNA-1273.222, would be formulated as a 50 µg booster dose for adults at least 18 years old, based on preclinical and clinical trial data. To date, the booster has met all of Moderna’s primary endpoints in testing, and the company maintained that if authorized, it could be ready to ship as early as September 2022.

“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster,” Moderna CEO Stéphane Bancel said. “Moderna’s mRNA platform has enabled us to develop, study, and deploy bivalent booster vaccine candidates that demonstrate superior protection against all tested COVID variants in record time. Our commitment to using cutting-edge science to protect the world against the ongoing COVID threat continues.”

The new vaccine formulation can face both the SARS-CoV-2 original strain and the BA.4/BA.5 subvariants of Omicron, which have come to dominate much of the modern spread. In testing, mRNA-1273.214 offered superior neutralizing antibody response against Omicron BA.1 when compared to a similar booster dose of the already-authorized mRNA-1273 in previously uninfected participants. It also provided potent responses against BA.4 and BA.5 compared to the authorized booster.

A Phase 2/3 trial of mRNA-1273.214 remains underway.