Moderna’s flu, COVID-19 combo vaccine passes key test

2024-06-10

疫苗临床结果信使RNA临床3期上市批准

Moderna’s combination vaccine against influenza and COVID-19 met the primary endpoints of a late-stage study, eliciting a higher immune response than comparator shots used in the trial. CEO Stéphane Bancel said on Monday "we are very delighted about the results,” as they position Moderna as “the only company with a positive Phase III flu and COVID combination vaccine.”

The jab, dubbed mRNA-1083, comprises components of Moderna’s vaccine candidate for seasonal flu mRNA-1010 and its next-generation COVID-19 shot mRNA-1283.

The study consisted of one group of adults 65 years and older who received mRNA-1083 or separate doses of Sanofi’s flu vaccine Fluzone HD and Moderna’s currently licensed COVID-19 jab Spikevax. The second group, comprising adults ages 50 to 64, received mRNA-1083 or separate shots of GSK’s flu vaccine Fluarix and Spikevax.

Results showed that the immune response from a single dose of mRNA-1083 was non-inferior to the co-administered vaccines, eliciting significantly higher immune responses against the H1N1, H3N2 and B/Victoria flu strains, as well as against SARS-CoV-2. Bancel suggested that the better performance compared to Spikevax was likely because mRNA-1083 has been designed to combat more recent variants of the coronavirus.

Moderna added that mRNA-1083 had an acceptable tolerability and safety profile in the study, with the majority of adverse reactions being Grade 1 or 2 injection-site pain, fatigue, myalgia and headache.

The company plans to present the data at an upcoming medical conference and engage with regulators on next steps. Meanwhile, Bancel suggested that mRNA-1083 could be launched next year and be more widely available in 2026.

Earlier this year, Moderna reached an agreement to bring in external funding of up to $750 million from Blackstone Life Sciences to support development of its mRNA-based flu vaccines, including mRNA-1010, as well as other combination shots to provide protection against flu, respiratory syncytial virus (RSV) and COVID-19. The drugmaker recently gained FDA approval for its RSV vaccine mRESVIA, marking the first step in its commercial efforts beyond COVID-19.

For further analysis, read Spotlight On: Will Moderna’s RSV vaccine help to deliver on the promise of mRNA?

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