Moderna announced on Monday that its combination COVID-19 and flu mRNA-1083 vaccine trial showed "promising" results and that the company would soon present its findings to regulators for next steps.
According to Moderna, the combination COVID-19 and flu vaccine "elicited statistically significantly higher immune responses" against three strands of the flu in addition to COVID. The Phase 3 study involved two different cohorts, one involving participants over age 65, and another including adults ages 50-64.
Moderna compared the immune response between those who were given mRNA-1083 versus those who were given doses of the flu shot Fluzone HD and Spikevax, Moderna's currently licensed COVID-19 vaccine. Moderna said the combination shot provided a more robust immune response than the standalone flu vaccine for adults over age 65 and a higher immune response against COVID-19 for adults over age 50.
Moderna also said mRNA-1083 had "an acceptable tolerability and safety profile." The shots had similar side effects to the standalone vaccines, Moderna said.
"Combination vaccines have the potential to 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," said Stéphane Bancel, CEO of Moderna. "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."
Coronavirus
FDA advisers urge targeting JN.1 strain in recipe for fall's COVID vaccines
On June 5, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted to recommend that a 2024-25 COVID shot be targeted against the JN.1 lineage of the virus. The recommendation gives guidance to vaccine makers on how to prepare updated COVID-19 shots for the coming season.
According to Centers for Disease Control and Prevention data, 22% of adults in the U.S. got a COVID-19 shot for the 2023-24 season. The CDC said 49% of American adults got a flu shot last season.
Everyone age 5 years and older should get an updated COVID-19 vaccine to protect against serious illness, the CDC recommends. The CDC also advises annual flu shots for everyone 6 months and older each flu season.
