Moderna Completes Application for Updated COVID-19 Booster

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

Moderna has completed its submission to the FDA for emergency use authorization for its omicron-targeting bivalent COVID-19 booster vaccine. The application is for a 50 µg booster dose for adults 18 years of age and older.

The update booster contains both the original strain of SARS-CoV-2, as well as the BA.4/BA.5 subvariants of the omicron strain. Moderna's application is based on preclinical data, as well as clinical trial data from a phase 2/3 studying the updated booster vaccine that targets the omicron BA.1 subvariant. In the study, the updated booster met all primary endpoints, including superior neutralizing antibody response against omicron (BA.1) when compared with a 50 µg booster dose in previously uninfected participants, as well as potent neutralizing antibody responses against the omicron subvariants BA.4 and BA.5 compared with the currently authorized booster.

“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, “ Stéphane Bancel, chief executive officer of Moderna, said in a press release.

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

Related: Pfizer Submits EUA for Updated COVID-19 Booster

This follows Pfizer’s submission yesterday of an updated booster vaccine.