Analysis Shows Positive Data for Moderna’s Omicron BA.1-Targeting Vaccine

Study results indicate durable immune response from bivalent booster after 3 months of follow-up.

Moderna announced new clinical data on the Omicron-containing booster, mRNA-1273.214.

After 90 days, the fourth 50-µg booster dose in individuals who were previously vaccinated and boosted, regardless of prior infection, of mRNA-1273.214 elicited a superior neutralizing antibody response compared with a 50-µg booster dose of mRNA-1273 against the Omicron BA.1 variant.

Additionally, the response against Omicron BA.1 was durable and had higher antibody titers sustained through 3 months.

“Our bivalent boosters continue to demonstrate a strong, enduring response to COVID-19 variants of concern,” Stéphane Bancel, CEO of Moderna, said in a statement.

“Clinical trial data now indicate that the superior immune response produced by our bivalent booster has durability for at least 3 months,” he said. “As COVID-19 remains a global threat and a leading cause of death globally, this is an encouraging development, showing that a bivalent booster dose will offer important protection leading into the winter months."

mRNA-1273.214 showed significantly higher neutralizing antibody responses against Omicron BA.4/BA.5 compared with mRNA-1273 28 days after administration. Potent responses were also seen against Omicron BA.2.75 28 days after administration.

The bivalent booster elicits broad cross-neutralization against Omicron variants, according to the statement.

The adverse events of mRNA-1273.214 were similar or less severe than those of either a second or third dose of mRNA-1273, with no new safety concerns identified in the 3-month follow-up.

Moderna shared the complete data during a breakout session on October 20, 2022, at ID Week. The data will also be submitted for peer-reviewed publication and shared with regulatory agencies around the world.

The company expects interim immunogenicity and safety results of the bivalent vaccine mRNA-1273.222 to be available in 2022. The data will be generated from a clinical study designed in accordance with regulatory recommendations for bivalent booster vaccines for COVID-19.

The FDA has not approved or licensed the vaccine, but it authorized under an emergency use authorization to prevent COVID-19.

The vaccine is authorized for use in individuals aged 6 months and older as a primary series. The bivalent vaccine is authorized as a booster dose in individuals aged 6 years and older.

Reported adverse events (AEs) reactions in clinical trials for individuals aged 6 years and olde, included arthralgia, axillary swelling or tenderness, chills, erythema at the injection site, fatigue, fever, headaches, myalgia, nausea, pain at the injection site, swelling at the injection side, and vomiting, according to the statement.

Reported AEs for individuals aged 6 months through 5 years included arthralgia, axillary or groin swelling or tenderness, chills, crying, erythema at the injection site, fatigue, fever, headaches, irritability, loss of appetite, myalgia, nausea, pain at the injection site, sleepiness, swelling at the injection site, and vomiting.

Anaphylaxis, myocarditis, pericarditis, severe allergic reactions, and syncope were reported following administration of the vaccine during mass vaccination and outside clinical trials.

Reference

90-day analysis shows Moderna’s Omicron BA.1-targeting bivalent vaccine, mRNA-1273.214, demonstrates superior antibody response as fourth booster compared to SPIKEVAX prototype booster. News release. Moderna. October 19, 2022. Accessed October 21, 2022. https://investors.modernatx.com/news/news-details/2022/90-Day-Analysis-Shows-Modernas-Omicron-BA.1-Targeting-Bivalent-Vaccine-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-as-Fourth-Booster-Compared-to-Spikevax-Prototype-Booster/default.aspx