Moderna has announced new clinical data for its bivalent Omicron (BA.1) COVID-19 booster candidate, mRNA-1273.214. The bivalent candidate contains 25mcg of the currently authorized booster (mRNA-1273) and 25mcg of an Omicron subvariant.
Findings showed that 1 month after administration, the 50mcg booster dose of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against Omicron subvariants BA.4 and BA.5, regardless of prior infection status or age (adults over 18 years old, greater or less than 65 years old), compared with a booster dose of mRNA-1273.
Among individuals without prior infection, significantly higher neutralizing titers against subvariants BA.4 and BA.5 were observed with the bivalent mRNA-1273.214 candidate compared with the currently authorized booster. The geometric mean ratio was 1.69 (95% CI, 1.51-1.90).
Findings also showed BA.4/5 neutralizing titers were 775 (95% CI, 719-838) for the bivalent booster candidate and 458 (95% CI, 421-499) for the currently authorized booster at 1 month post vaccination. Compared with prebooster levels, the BA.4 and BA.5 geometric mean fold rise was 6.3-fold (95% CI, 5.7-6.9) for the mRNA-1273.214 group and 3.5-fold (95% CI, 3.2-3.9) for the mRNA-1273 group.
Study results were consistent across subgroups, including participants 65 years of age and older.
“This superior breadth and durability of immune response following a bivalent booster has now been shown in multiple phase 2/3 studies involving thousands of participants,” said Stephane Bancel, Chief Executive Officer of Moderna. “We are working with regulators to advance 2 bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants, clinical data requirements, and urgency of starting fall booster campaigns for vulnerable populations.”
The Company will also be developing the second bivalent booster candidate, mRNA-1273.222, based on the BA.4/5 strain.
Moderna’s omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrates significantly higher neutralizing antibody response against omicron subvariants BA.4/5 compared to currently authorized booster. News release. Moderna, Inc. Accessed July 11, 2022. https://investors.modernatx.com/news/news-details/2022/Modernas-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Significantly-Higher-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA.45-Compared-To-Currently-Authorized-Booster/default.aspx