Moderna: Combination COVID-19–Flu Vaccine Trial Meets Primary Endpoints


The vaccine, mRNA-1083, elicited noninferior responses vs individual COVID-19 and flu vaccinations.

The phase 3 trial of an investigational combination influenza-COVID-19 vaccine mRNA-1083 has met its primary endpoints, according to a Moderna news release.1

The ongoing trial (NCT06097273) is a randomized, observer-blind, active controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083. The study includes 2 independent age group cohorts of approximately 4000 adults each. In a cohort of adults aged 65 years and older, investigators compared mRNA-1083 to co-administered Fluzone HD and Spikevax; the second cohort, including adults aged 50 to 64 years, received either mRNA-1083 or Fluarix plus Spikevax.

mRNA-1083 is a combination vaccine targeting influenza and COVID-19. | Image credit: donfiore -

mRNA-1083 is a combination vaccine targeting influenza and COVID-19. | Image credit: donfiore -

Investigators found that the immune responses from a single mRNA-1083 dose were noninferior to the coadmininstered comparators. In both cohorts, mRNA-1083 also “elicited statistically significantly higher immune responses” against 3 strains of influenza virus—H1N1, H3N2, and B/Victoria), as well as against SARS-CoV-2. In the cohort of adults aged 65 years and older, overall Geometric Mean Ratios (GMRs) of the mRNA-1083 group were 1.155, 1.063, and 1.118 for influenza A/H1N1, influenza A/H3N2, and B/Victoria, respectively. GMR for mRNA-1083 vs Spikevax was 1.641 for the Omicron XBB.1.5 SARS-CoV-2 variant.

READ MORE: COVID-19 Vaccine Booster Dose Beneficial to Immunocompromised Patients

Results were similarly positive in the cohort of adults aged 50 to 64 years: 1.414, 1.380, and 1.216 for A/H1N1, A/H3N2, and B/Victoria for mRNA-1083 vs Fluarix and 1.308 for XBB.1.5 for mRNA-1083 vs Spikevax.

Immunogenicity was evaluated vs the B/Yamagata strain and met noninferiority criteria in both cohorts; however, due to the disappearance of the B/Yamagata linage from circulation, the World Health Organization recommended a trivalent vaccine composition for the 2024/2025 flu season.

“Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses,” said Moderna CEO Stéphane Bancel in a news release. “Moderna is the only company with a positive phase 3 flu and COVID combination vaccine.”

“Building on the momentum of positive phase 3 data…we continue to address significant unmet medical needs and advance public health,” he added.

Tolerability and safety of mRNA-1083 were acceptable. The majority of adverse reactions were grade 1 or grade 2 in severity, and most commonly included injection site pain, fatigue, myalgia, and headache.

The company intends to present these phase 3 trial data at an upcoming medical conference and will submit the data for publication.

READ MORE: Immunization Resource Center

1. Moderna announces positive phase 3 data for combination vaccine against influenza and COVID-19. News release. Moderna. June 10, 2024. Accessed June 10, 2024.
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