Moderna Successfully Completes Phase 2/3 Clinical Trials for Omicron-Targeted Vaccine

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] Moderna's bivalent vaccine 'mRNA-1273.214,' developed to respond to the Omicron variant, has succeeded in clinical phases 2 and 3. mRNA-1273.214 is a bivalent vaccine that combines the existing vaccine 'Spikevax (mRNA-1273)' with a vaccine candidate targeting the Omicron variant.

On the 8th (local time), Moderna announced the results of clinical phases 2 and 3 showing that administering an additional 50㎍ of mRNA-1273.214 one month after vaccination achieved all pre-specified evaluation endpoints, including superior neutralizing antibody responses against the Omicron variant compared to the existing vaccine. Tolerability was generally favorable, and side effects were confirmed to be at a similar level to those of additional doses of the existing vaccine.

In this phase 2/3 clinical trial, mRNA-1273.214 met all major evaluation endpoints, including neutralizing antibody responses against Omicron, compared to a 50㎍ additional dose of Spikevax in clinical subjects without prior COVID-19 infection. The superiority evaluation method used the geometric mean ratio (GMR) of neutralizing antibodies, achieving the goal of the lower bound of the confidence interval being greater than 1.

When mRNA-1273.214 was administered as an additional dose, neutralizing antibodies against Omicron increased approximately eightfold. The non-inferiority evaluation endpoint for the original virus was also achieved. The GMR for the original virus was 1.22 (1.08?1.37).

One month after vaccination, the geometric mean titer (GMT) of neutralizing antibodies against the original virus for mRNA-1273.214 was 5977, a higher figure compared to the basic vaccine's GMT of 5649. The GMT against the Omicron variant was 2372, whereas the existing vaccine recorded only 1473. Additionally, compared to the existing vaccine, the mRNA-1273.214 group showed higher binding antibody titers against all variants of concern, including Alpha, Beta, Gamma, Delta, and Omicron.

Moderna CEO St?phane Bancel said, "We are pleased to release the initial data on mRNA-1273.214," adding, "This symbolizes innovation against COVID-19." He further stated, "mRNA-1273.214 is Moderna's leading vaccine candidate containing Omicron as a bivalent vaccine, aiming for additional dose use this fall," and added, "Applications for regulatory approval are underway with governments worldwide."

This content was produced with the assistance of AI translation services.