COVID-flu shot offers strong immune response in late-stage trial, Moderna says

Moderna said on Monday its combination vaccine to protect against both COVID-19 and influenza generated a stronger immune response in adults aged 50 and over when compared to separate shots against the viruses in a late-stage trial.

In the study, the combination using messenger RNA technology generated greater antibodies than currently marketed traditional flu vaccines and Moderna’s Spikevax mRNA COVID shot, the company said.

The vaccine, called mRNA-1083, elicited a higher immune response against two A strains and one B strain of the flu in older adults when compared with widely used flu shots from GSK and Sanofi, according to the company.

The U.S. Food and Drug Administration in March recommended drugmakers target those three strains, called H1N1, H3N2, and B/Victoria, when developing their seasonal flu vaccines for 2024.

The latest data was collected from two arms of a larger study that involved around 8,000 people – one tested the combination against GSK’s Fluarix in adults aged 50 to 64 and another against Sanofi’s Fluzone HD in people 65 and older. Fluzone is a high-dose vaccine for older people.

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Moderna President Stephen Hoge said the drugmaker hopes to launch the combination shot for the autumn respiratory disease season in 2025. “If not 2025, then 2026,” he said.

The Cambridge, Massachusetts-based company has been banking on new vaccines to make up for vastly lower demand and sales for its COVID shot.

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If approved, the combination vaccine would be Moderna’s third marketed product, having received FDA approval for its respiratory syncytial virus (RSV) vaccine last month.

Moderna also said the combination was found to be safe and tolerable in the latest study, and that rates of adverse side effects were similar to those of the other vaccines used in the trial.

The most common side effects were injection site pain, fatigue, muscle aches and headache, Moderna said.

The company said it expects to release the full results from the study at an upcoming medical conference.

(Reporting by Patrick Wingrove; Editing by Bill Berkrot)