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# Moderna Seeks EUA for Omicron-targeting Booster
- URL: https://www.fdaweb.com/moderna-seeks-eua-for-omicron-targeting-booster/
- Published: 2022-08-23T12:00:00.000Z
- Updated: 2026-09-14T17:56:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152573

A day after Pfizer/BioNTech announced their submission of an emergency use authorization (EUA) request for a modified Covid-19 booster vaccine, Moderna 8/23 says it has submitted an EUA for a similar BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222\. Moderna's submission is seeking its booster dose for adults 18 years of age and older, and is based on preclinical data and clinical trial data from the company’s BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.

The clinical data 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 says.

The company says a Phase 2/3 trial for mRNA-1273.222 is currently underway. It also has rapidly scaled manufacturing to be ready, if authorized, to deliver doses next month.