Moderna Files for Authorization for Its Bivalent COVID-19 Vaccine Booster

The company announced it has completed its paperwork for filing for an EUA with the FDA for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222.

"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. Our commitment to using cutting-edge science to protect the world against the ongoing COVID threat continues."

The 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. Moderna's application to the FDA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a phase 2/3 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.

This comes on the heels of Pfizer-BioNTech completing their application yesterday for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Their EUA filing is for individuals 12 years and older.

Federal government officials and the medical community have been discussing Americans getting booster doses for COVID-19 along with their annual influenza immunizations. Some believe that going forward they are going to try to have both done at the same time. People would have the vaccines administered concurrently with 2 shots, or in a combination vaccine. Moderna, for example, is working on an influenza and COVID-19 vaccine.