Moderna’s Booster Candidate Demonstrates Superior Antibody Response Against Omicron

Data show significantly higher geometric mean titer ratios, meeting prespecified endpoints for superiority against the variant.

Moderna announced clinical data on its Omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.214, according to a statement from the company.

The booster candidate contained mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern.

The 50-µg booster dose met all pre-specified endpoints, including superior neutralizing antibody response, which is the geometric mean ratio (GMR), against the Omicron variant 1 month after administration compared with the original mRNA-1273 vaccine.

Further, the booster dose was generally well-tolerated with adverse events (AEs) comparable to a booster dose of mRNA-1273 at the 50-µg dosage.

“We are thrilled to share the preliminary data analysis on mRNA-1273.214, which is the second demonstration of superiority of our bivalent booster platform against variants of concern and represents an innovation in the fight against COVID. Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a fall 2022 booster,” Stéphane Bancel, CEO of Moderna, said in a statement.

“We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer. Taken together, our bivalent booster candidates demonstrate the power of Moderna's mRNA platform to develop vaccines that meet immediate, global public health threats,” Bancel said.

The booster candidate met all primary endpoints in the phase 2/3 trial, including neutralizing antibody response against the Omicron variant compared with a 50-µg dose of the mRNA-1273 in individuals at baseline seronegative.

Pre-specified criteria for superiority as measured by neutralizing GMR with the lower bound of the confidence greater than 1 was met. The GMR and corresponding 97.5% confidence interval was 1.75.

A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against the Omicron variant, approximately 8-fold above baseline levels/

The primary endpoints of non-inferiority against ancestral SARS-CoV-2 were also met with GMR against ancestral SAR-COV-2 of 1.22.

Among individuals who were seronegative 1 month after administration, the neutralizing GMT against ancestral SARS-CoV-2 for mRNA-1273.214 was 5977 compared with GMT for mRNA-1273 of 5649. The GMT against the Omicron variant was 2372 compared with 1473, respectively.

Binding antibody titers were also significantly higher against all other variants of concern, including the Alpha, Beta, Gamma, Delta, and Omicron, for the booster candidate compared with the original vaccine.

The booster dose was well-tolerated in 437 individuals in the study. The safety and reactogenicity profile of the mRNA-1273.214 50-µg dosage was similar to that of the mRN-1273 50-µg dosage when these vaccines were administered as a second booster dose.

In February 2021, Moderna announced its strategy of updating booster candidates to address the evolution of the SARS-CoV-2 virus, including bivalent and monovalent candidates targeting multiple variants of concern.

Results from the beta-containing bivalent booster candidate, mRNA-1273.211, announced in April 2022, demonstrated superiority against the Beta, Delta, and Omicron variants 1 month after administration and continued superiority that was durable against the Beta and Omicron variant’s 6 months after administration.

Moderna anticipates that the antibody titers produced by mRNA-1273.214will be more durable over time against the Omicron variant compared with the original vaccine. The company plans on reporting data from day 91 after vaccination later in the summer.

Reference

Moderna announces Omicron-containing bivalent booster candidate mRNA-1273.214 demonstrates superior antibody response against Omicron. Moderna. News release. June 8, 2022. Accessed June 10, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx