Moderna’s late-stage trial for its COVID-flu combination vaccine yielded positive results, the pharmaceutical and biotechnology company announced Monday.
The combination vaccine, which Moderna calls mRNA-1083, produced a higher immune response than standalone vaccines for COVID-19 or influenza. The results were also seen among trail participants 65 years and older, whom often don’t show as strong a response to vaccines as younger individuals.
The announcement makes Moderna the first to report positive Phase 3 data for its combination vaccine, giving the company a slight edge over Pfizer and BioNTech, which began a Phase 3 trial for its combined flu and COVID-19 vaccine last year. Vaccine developer Noravax is also testing a combined shot for the same viruses.
“Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health,” Moderna CEO Stéphane Bancel said in a statement.
Bancel told MSNBC Moderna is planning to file for regulatory approval for the combination shot this summer in the U.S. and seeks to enter it into the market in 2025.
She said Monday that the combination shot will hopefully reduce the “burden” of respiratory viruses on health systems and pharmacies while providing patients with a more convenient vaccination option.
The mRNA-1083 vaccine is made up of Moderna’s vaccine candidate for seasonal influenza and mRNA-1283, its “next-generation” COVID-19 vaccine candidate. Each of the experimental vaccines showed positive Phase 3 clinical trial results.
The Phrase 3 trial for the combined vaccine involved 8,000 patients. In one cohort of about 4,000 adults aged 65 years and older, researchers compared the combination shot with Fluzone HD, an enhanced flu vaccine, and Spikevax, Moderna’s currently licensed COVID-19 shot.
In a second cohort of adults between the ages of 50 and 64, the study compared the combination vaccine with Fluarix, a standard flu shot, and Spikevax.
Moderna’s combination vaccine in both groups produced “statistically significantly higher immune responses” against three flu strains and COVID-19.
The safety and tolerability of the shot were “acceptable,” the company said, adding the most severe reactions included pain, fatigue, myalgia and headache.