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Moderna on Monday said its combination vaccine that targets both Covid-19 and the flu was more effective than existing standalone shots for those viruses in a late-stage trial.
The biotech company is the first to release positive phase three data on a Covid and flu combination shot, giving it a potential lead over rival vaccine makers Pfizer and Novavax.
Moderna plans to file for regulatory approval for its combination jab this summer in the U.S. and hopes it can enter the market in 2025, the company’s CEO Stephane Bancel said in an interview.
Moderna, Pfizer and Novavax have said that combination shots will simplify how people can protect themselves against respiratory viruses that typically surge around the same time of the year. The added convenience is critical as fewer Americans roll up their sleeves to get vaccinated against Covid.
Bancel added that combination shots could reduce the burden of respiratory viruses on pharmacists and the broader U.S. health-care system, which has been grappling with a labor shortage that has many workers stretched thin.
Moderna’s messenger RNA combination shot, called mRNA-1083, is made up of both the company’s vaccine candidate for seasonal influenza and a newer, “next-generation” version of its Covid shot. Both of those experimental vaccines – mRNA-1010 and mRNA-1283 – have shown positive results in separate phase three trials.
The ongoing late-stage trial on mRNA-1083 examined the combination shot in 8,000 patients.
The study compared the combination shot with an enhanced flu vaccine called Fluzone HD and Moderna’s currently licensed Covid shot, Spikevax, in one group of patients ages 65 and above. The trial also compared Moderna’s combination jab with a standard flu shot called Fluarix and Spikevax in another group of participants between the ages of 50 and 64.
In both age groups, a single dose of Moderna’s combination vaccine produced “statistically significantly higher” immune responses against three strains of influenza and the Covid omicron variant XBB.1.5.
Moderna said the safety of the combination shot, along with how well patients could tolerate it, was acceptable. The most common side effects were injection site pain, fatigue, muscle pain and headache. The majority of those effects were mild to moderate in severity.
Moderna is also developing a combination shot targeting the flu and RSV, and another vaccine targeting all three respiratory viruses: Covid, flu and RSV.
Meanwhile, Pfizer and BioNTech also are studying a vaccine that targets both Covid and the flu in a late-stage trial. Novavax is developing a combination for those viruses as well, but its Covid shot uses protein-based technology.