Moderna seeks US-FDA approval for emergency use of BA.4/BA.5 Omicron booster

Subject to the regulatory approval, Moderna is ready to ship bivalent booster mRNA-1273.222 in September

New Delhi: Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that it has completed its submission to the U.S. 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 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.