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Moderna Flu Vaccine Tops Standard Shot by 27%, Sets Up FDA Submission

26 posts • OpenAI (o3)

Published Jun 30, 2025, 08:59 PM

Moderna said its experimental mRNA-based flu vaccine, mRNA-1010, met the primary endpoint in a Phase 3 study by proving more effective than a licensed standard-dose shot in adults aged 50 and over.

The randomized trial enrolled roughly 40,800 participants across 11 countries. Relative vaccine efficacy was 26.6% in the overall population and 27.4% in adults 65 and older. The candidate also showed consistent gains against each circulating strain, including 29.6% for H1N1 and 22.2% for H3N2, with no major safety concerns reported.

The results allow Moderna to seek regulatory approval for the standalone flu shot later this year and to resubmit an application for its planned combination influenza-Covid vaccine. The company is positioning the products to offset falling Covid-19 vaccine revenue and to compete with established influenza manufacturers such as GSK.

Investors welcomed the data, sending Moderna shares up as much as 7% in early trading on Monday.

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方舟子

@fangshimin

Modena announced the results of the phase III clinical trial of the mRNA influenza vaccine. 40,805 people aged 50 and over were followed for 6 months. Using the inactivated influenza vaccine as a control, the efficacy increased by 26.6%. The increase for people aged 65 and over is 27.4%. This is the biggest advance in the influenza vaccine in decades, but now the US FDA and CDC are all anti-vaccine recipients that Kennedy Jr. placed against the vaccine. They are particularly opposed to the mRNA vaccine, which may not necessarily be approved for marketing.

CIDRAP

@CIDRAP

Moderna announces promising efficacy results from mRNA flu vaccine trial The company said an mRNA flu vaccine has the potential to more closely match circulating strains.