Moderna Requests Emergency Use Authorization for COVID-19 Bivalent Vaccine

August 24, 2022

Moderna filed with the FDA for emergency use authorization of a 50-µg dose of a BA.4./BA.5 Omicron-targeting bivalent booster vaccine for those aged ≥18 years.

Biotech company Moderna announced on Tuesday that it had completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for the company’s bivalent mRNA COVID-19 booster vaccine targeting Omicron variants BA.4/BA.5, mRNA-1273.222. If the EUA is granted, the vaccine would be available for those aged ≥18 years.

The mRNA-1273.222 bivalent vaccine candidate targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain, according to the company. Moderna’s application for the EUA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a phase 2/3 study that evaluated a bivalent booster vaccine (mRNA-1273.214) that targeted the Omicron BA.1 subvariant.

Findings from the phase 2/3 study demonstrated that mRNA-1273.214 met all primary study endpoints. When it was compared to a 50-µg booster dose of the currently authorized Moderna COVID-19 booster (mRNA-1273) in previously uninfected participants, mRNA-1273.214 was associated with superior neutralizing antibody response against Omicron (BA.1) as well as potent neutralizing antibody responses against the BA.4 and BA.5 virus subvariants, regardless of prior infection status or participant age.

The bivalent mRNA-1273.222 is now being evaluated in a phase 2/3 trial, the company says

"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," Moderna CEO Stéphane Bancel, said in a statement. "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.”

The announcement arrives one day after Pfizer and BioNTech announced completion of their filing for EUA of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine which would be available for individuals aged ≥12 years.

If authorized, according to Moderna, the company is ready to begin shipment in September of the bivalent booster mRNA-1273.2222.