Moderna Applies for EUA for Omicron-Targeting Bivalent COVID-19 Booster Candidate

Moderna, Inc has applied for an FDA emergency use authorization (EUA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. The EUA submission for a 50 µg booster dose for individuals aged 18 years and older is based on preclinical data and clinical trial data for the BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.

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

The mRNA-1273.222 vaccine candidate targets both the original SARS-CoV-2 strain in addition to the BA.4/BA.5 subvariants of the Omicron strain. The EUA submission is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a phase 2/3 trial evaluating mRNA-1273.214.

In testing, mRNA-1273.214 demonstrated significantly higher antibody titers against all tested variants, including Omicron BA.1 and BA.4/5 subvariant, ancestral virus, Alpha, Beta, Delta, and Gamma.

The company shared clinical data showing that 1 month after administration in participants who were previously vaccinated and boosted, a 50-µg booster does of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster, mRNA-1273.

Bivalent mRNA-1273.214 resulted in significantly higher neutralizing titers against BA.4/5 compared to the currently authorized booster for participants without prior infection, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90). BA.4/5 neutralizing titers were 776 for mRNA 1273.214 (95% CI: 719, 838) compared with 458 for the currently authorized booster (95% CI: 421, 499) at 1 month after booster.

The BA.4/5 geometric mean fold rise (GMFR) from pre-booster levels was 6.3-fold (95% CI: 5.7, 6.9) for participants who received mRNA-1273.214 and 3.5-fold (95% CI: 3.2, 3.9) for participants who received mRNA-1273.

This clinical data adds to results shared last month from Moderna’s ongoing phase 2/3 study in approximately 800 participants. Previous results showed a 50-µg booster dose of mRNA-1273.214 met all pre-specified primary end points. The booster does was generally well tolerated by patients, with a reactogenicity and safety profile considered consistent with the currently authorized booster.

Moderna developed mRNA-1273.222 in accordance with FDA guidance for a BA.4/BA.5-targeting bivalent vaccine. A phase 2/3 trial for mRNA-1273.222 is ongoing and Moderna has rapidly scaled manufacturing of the vaccine to be ready for delivery in September if the EUA is authorized by the FDA, the company announced in a press release.

The submission is the second EUA application filed to the FDA this week for a variant-targeting COVID-19 vaccine.

Pfizer and BioNTech have submitted an EUA application to the FDA for an Omicron-adapted bivalent COVID-19 vaccine, following positive data showing its efficacy.

Data support the request for an EUA of a 30-µg booster dose of an Omicron-adapted bivalent COVID-19 vaccine in individuals 12 years of age and older. The companies have rapidly scaled production and are prepared to deliver doses of the vaccine for September, and will begin shipping immediately pending authorization, according to a press release.

Reference

Moderna Completes Application to U.S. Food and Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222. Moderna Inc. News release. August 23, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Completes-Application-To-U.S.-Food-And-Drug-Administration-For-Emergency-Use-Authorization-Of-Omicron-Targeting-Bivalent-Covid-19-Booster-Vaccine-mRNA-1273.222/default.aspx