Moderna completes application To FDA for Emergency Use Authorization Of Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222.
Moderna, Inc. announced that it has completed its submission to the FDA for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222
Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4/BA.5-targeting bivalent vaccine. A Phase II/III 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.
Moderna's application to the FDA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase II/III 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.
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