Moderna has reported new findings from Phase II/III clinical trial where its Omicron-containing bivalent Covid-19 booster candidate, mRNA-1273.214, showed greater antibody response against the Omicron variant of the SARS-CoV-2 virus.

The mRNA-1273.214 vaccine comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the Omicron variant. 

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According to the latest data, a 50µg booster dose of the vaccine met all pre-specified endpoints including greater neutralising antibody response (geometric mean ratio (GMR)) against Omicron one month following dosing versus the mRNA-1273 vaccine. 

Furthermore, the booster shot of mRNA-1273.214 was found to be well-tolerated with side effects in line with the booster dose of mRNA-1273.

The GMR and corresponding 97.5% confidence interval were reported to be 1.75. 

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A booster dose of mRNA-1273.214 raised neutralising geometric mean titers (GMT) against Omicron nearly eight-fold above baseline levels. 

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In addition, the trial met primary endpoints of non-inferiority against ancestral SARS-CoV-2, with GMR against this virus being 1.22.

A month after dosing, the neutralising GMT against ancestral SARS-CoV-2 for mRNA-1273.214 was 5977 versus 5649 for mRNA-1273 in seronegative subjects. 

The GMT against Omicron for mRNA-1273.214 was 2372 versus 1473 for mRNA-1273.

As against mRNA-1273, binding antibody titers (MSD) were found to be substantially raised against all other variants of concern for mRNA-1273.214. 

A 50μg booster dose of mRNA-1273.214 had safety and reactogenicity profile in line with 50μg mRNA-1273 when these vaccines were given as a second booster shot.

Moderna CEO Stéphane Bancel said: “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.” 

The company anticipates submitting the interim assessment and findings to regulatory agencies for review soon.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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