Two shots in one? Moderna's COVID-19 and flu vaccine reports favorable results
Moderna said Monday that its combination vaccine against flu and COVID-19 drew a greater immune response in late-stage study results than two comparable vaccines on the market.
The company's investigational vaccine, mRNA-1083, combines a vaccine candidate for seasonal influenza and an updated COVID-19 vaccine. Both vaccines have been independently tested and yielded positive results in late-stage clinical trials, according to Moderna, which is based in Cambridge, Massachusetts.
The randomized study evaluated the safety, reactions and immune response in people who had received the two-in-one combination vaccine, testing it in two groups of about 4,000 adults each.
The combination vaccine elicited greater immune response than existing vaccines designed to protect against COVID-19 and three strains of flu: H1N1, H3N2 and B/Victoria, Moderna said in a news release.
Moderna expects to present the Phase 3 study data at an upcoming medical conference and plans to submit the information to a peer-reviewed medical journal.
The adverse reactions to the combination vaccine were mostly minor and included complaints such as pain at the injection site, fatigue, muscle discomfort and headaches. The company said it would work with regulators about the next steps for the combination vaccine, which the Food and Drug Administration has granted a fast-track designation. Moderna has not said when the combination vaccine might be evaluated by the FDA.
Both Pfizer-BioNTech and Novavax are studying combination vaccines to protect against COVID-19 and influenza.
Moderna: Combination vaccine elicited 'higher immune responses'
After giving the vaccine to a group of adults 65 and older, the Moderna study compared reactions to the combination vaccine to those of the FDA-approved high-dose vaccine Fluzone and Moderna's existing COVID-19 vaccine, Spikevax. The second group of adults who received the vaccine were 50 to 64. They received either the combination vaccine or were co-administered the on-the-market flu vaccine, Fluarix and Spikevax.
When compared with the existing vaccines in both age groups, Moderna's combination "elicited statistically (significant) higher immune responses" to the three flu strains and COVID-19, Moderna said.
Stéphane Bancel, CEO of Moderna, said in a statement that combination vaccines can "reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses."
Moderna said the combination vaccine also showed a sufficient immune response to the B/Yamagata strain of influenza; that strain, however, is no longer circulating, and the World Health Organization has recommended the trivalent flu vaccines for the 2024-2025 flu season be made without protection against that strain.
Last month, the FDA approved Moderna's respiratory syncytial virus vaccine, the second approved product for the COVID-19 vaccine maker. The RSV shot is the first messenger-RNA-based vaccine not for COVID-19 to be approved in the United States. It will be sold under the brand name mRESVIA for adults 60 or older.
Moderna has sought to expand its portfolio of vaccines beyond Spikevax, its only marketed product. Moderna and Merck also are jointly developing a cancer vaccine.
This article originally appeared on USA TODAY: Moderna reports flu and COVID-19 vaccine phase 3 study results