Moderna Inc has completed its submission to the FDA for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222. The application is for a 50 µg booster dose for adults 18 years of age and older, and is based on preclinical data as well as clinical trial data available for the company’s BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.

“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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.”

mRNA-1273.222 targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain. Moderna’s application to the FDA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, a bivalent booster vaccine targeting the Omicron BA.1 subvariant. In the study, mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in previously uninfected participants, as well as potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.

Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4/BA.5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Moderna has rapidly scaled manufacturing of mRNA-1273.222 in order to be ready, if authorized, to deliver doses in September.