New Clinical Data for Bivalent COVID-19 Booster Candidate Shows Potent Response Against Omicron Variant

Moderna announced new clinical data on its bivalent COVID-19 booster candidate for the Omicron variant, mRNA-1273.214.

At 1 month post administration in individuals previously vaccinated and who received a booster, a 50-µg booster dose of mRNA-1273.214 had a potent neutralizing antibody response against the Omicron subvariants, BA.4 and BA.5, in all individuals regardless of prior infection.

Based on the new and previous data, Moderna is working to complete regulatory submissions in the coming weeks, requesting to update the composition of the booster vaccine to mRNA-1273.214.

"In the face of SARS-CoV-2's continued evolution, we are very encouraged that mRNA-1273.214, our lead booster candidate for the fall, has shown high neutralizing titers against the BA.4 and BA.5 subvariants, which represent an emergent threat to global public health," Stéphane Bancel, CEO of Moderna, said in a statement.

"We will submit these data to regulators urgently and are preparing to supply our next generation bivalent booster starting in August, ahead of a potential rise in SARS-CoV-2 infections due to Omicron subvariants in the early fall."

Investigators found the mRNA-1273.214 booster increased neutralizing titers against both subvariants by 5.4-fold above baseline in all individuals regardless of prior infection and by 6.3-fold in a subset of individuals who are seronegative. Prior studies of the third dose of the prototype booster induced neutralizing GMT against BA.1 of 629 and against Delta of 828.

A third dose of the prototype booster demonstrated effectiveness against the Delta variant and BA.1. infection and hospitalization in observational studies.

The new data build on earlier data shared from the company’s ongoing phase 2/3 study in approximately 800 individuals. The previous results indicated a 50-µg booster dose of mRNA-1273.214 met all pre-specified primary endpoints, including superiority in neutralizing antibody GMT against the Omicron variant when compared to a 50-µg booster dose of the prototype booster, 50-µg booster dose of mRNA-1273.213.

The bivalent booster was generally well-tolerated, with a reactogenicity and safety profile that was consistent with the prototype booster. Moderna will continue to collect data and update the composition of the booster to bivalent mRNA-1273.214 for the fall.

Moderna has already shared these data with regulators and is submitting a manuscript for peer reviewed publication.

Reference

Moderna announces bivalent booster mRNA-1237.214 demonstrated potent neutralizing antibody response against Omicron subvariants BA.4 and Ba.5. Moderna. News release. June 22, 2022. Accessed June 27, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Bivalent-Booster-mRNA-1273.214-Demonstrates-Potent-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA.4-And-BA.5/default.aspx