Moderna completes FDA filing for bivalent COVID-19 booster vaccine, MRNA-1273.222

US mRNA specialist biotech Moderna (Nasdaq: MRNA) says that it has completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222.

The application is for a 50µg 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 of Moderna, adding: "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."