Moderna plans to file for regulatory approval for its compound jab in the U.S. this summer, and hopes it can enter the market by 2025, the company’s CEO Stephen Bancell said in an interview.
Moderna, Pfizer and Novavax have said the combination shots will simplify how people can protect themselves against respiratory viruses that typically crop up around the same time of year. The added convenience is especially important as fewer Americans are rolling up their sleeves to get vaccinated against Covid.
Bancell added that the scenarios could reduce the burden of respiratory viruses on pharmacists and the broader U.S. health care system, which are struggling with labor shortages that have stretched many workers thin.
Moderna’s messenger RNA combination shot, called MRNA-1083, contains both the company’s vaccine candidate for seasonal flu and a new, “next-generation” version of its Covid shot. Both of those experimental vaccines — mRNA-1010 and mRNA-1283 — have shown positive results in three separate phase three trials.
An ongoing late-stage trial of mRNA-1083 tested the combination in 8,000 patients.
The study compared Fluzone HD and Moderna’s currently licensed Covid shot, a combination shot with an improved flu vaccine called SpikeVax, in a group of patients 65 and older. The trial also compared Moderna’s combination jab with standard flu shots called Flurix 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 greater” immune responses against three strains of influenza and the covid omicron variant XBB.1.5.
Moderna said the safety of the combination shot and how well patients tolerated it were acceptable. The most common side effects are injection site pain, fatigue, muscle pain, and headache. Most of those effects were mild to moderate in severity.
Moderna is developing a combination shot targeting flu and RSV, and another vaccine targeting three respiratory viruses: Covid, flu and RSV.
Meanwhile, Pfizer and BioNTech are studying a vaccine targeting both Covid and flu in late-stage trials. Novavax is developing a compound for those viruses as well, but its Covid shot uses protein-based technology.
