Investigational Influenza-COVID-19 Combination Vaccine Elicits Immune Response in Older Adults: Daily Dose

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Last week, we reported on new data from an ongoing phase 3 clinical trial examining the safety, reactogenicity, and immunogenicity of mRNA-1083, an investigational combination vaccine against influenza and SARS-CoV-2 in development by Moderna.

The study

The randomized, observer-blind, active control clinical trial is evaluating the immunogenicity, safety, and reactogenicity of mRNA-1083 across 2 independent age‐group substudy cohorts of approximately 4000 individuals aged 65 years and older and 4000 individuals aged 50 to 64 years.

In the former subgroup, mRNA-1083 was compared to coadministered enhanced influenza vaccine, Fluzone HD (Sanofi) and in the latter to a standard dose of the influenza vaccine, Fluarix (GSK). For both age groups, mRNA-1083 was compared to a standard dose of Moderna’s Spikevax COVID-19 bivalent booster shot.

The findings

Investigators found that a single dose of the investigational mRNA-1083 elicited immune responses that were noninferior compared to the coadministered and routinely recommended licensed comparator vaccines. Across the 2 age cohorts mRNA-1083 resulted in higher immune responses that were statistically significant against 3 influenza virus strains and against SARS-CoV-2.

In the older adult cohort, overall geometric mean ratios (GMR) among those treated with mRNA 1083 vs those treated with Fluzone HD for the 3 flu strains were 1.0 or greater. The combination vaccine's GMR compared with Spikevax for the SARS-CoV-2 Omicron variant XBB.1.5 was greater than 1.5.

Moderna reported an acceptable safety and tolerability for mRNA-1038, stating the majority of solicited adverse reactions were rated grade 1 or 2 in severity and were consistent with profiles of the licensed vaccines administered in the trial. They included injection site pain, fatigue, myalgia, and headache.

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