Influenza and COVID-19, combined vaccine: Moderna announces positive data in phase 3

Vaccines

Vaccines

June 10, 2024

The mRNA-1083 vaccine, a combination formulation against influenza and COVID-19 developed by Moderna, achieved its main objectives, eliciting higher immune responses against the influenza virus and SARS-CoV-2 compared to influenza vaccines and authorized anti-COVID. The result was achieved in adults 50 years and older, including an enhanced flu vaccine for adults 65 years and older. The company announced this in a statement: “Combination vaccines have the potential to reduce the burden of respiratory viruses on healthcare systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide greater protection.” for seasonal illnesses,” he said Stéphane Bancel, CEO of Moderna. “Moderna is the only company with a combined influenza and COVID-19 vaccine that achieved positive Phase 3 results. With this data, we are continuing to address important unmet medical needs and advance public health across the globe. our respiratory portfolio”. The company plans to present Phase 3 clinical data for mRNA-1083 at an upcoming scientific meeting and submit it for publication. The company will engage with regulatory authorities on next steps.

Studies on the combined vaccine
The mRNA combination vaccine includes components of the seasonal influenza vaccine candidate mRNA-1010 and the next-generation COVID-19 vaccine candidate mRNA-1283, both developed by Moderna. Each investigational vaccine has individually demonstrated positive results in Phase 3 clinical trials. The ongoing Phase 3 clinical trial (ClinicalTrials.gov ID: NCT06097273) is a randomized, observer-blind, active-control study evaluating safety , reactogenicity, and immunogenicity of mRNA-1083 in two independent cohorts of approximately 4,000 adults each. A cohort of adults 65 years and older compared mRNA-1083 with an enhanced influenza vaccine, and Moderna’s currently authorized COVID-19 vaccine. The other cohort of adults ages 50 to 64 compared imRNA-1083, another standard-dose flu vaccine, and Moderna’s currently authorized COVID-19 vaccine.

Immune responses from a single dose of mRNA-1083 were found to be non-inferior to those of licensed vaccines used as comparators and recommended for co-administration. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2. In the 65 and older cohort, the overall Geometric Mean Ratios (GMRs) of the mRNA-1083 group compared to the influenza vaccine group were 1155 (95% CI: 1094-1220) for A/H1N1, 1063 (95% CI: 1094-1220) 95%: 1007-1122) for A/H3N2 and 1118 (95% CI: 1070-1167) for B/Victoria. The GMR of mRNA-1083 compared to Moderna’s currently authorized COVID-19 vaccine for the SARS-CoV-2 Omicron XBB.1.5 variant was 1641 (95% CI: 1526-1765). In the 50 to 64 age cohort, the GMRs of the mRNA-1083 group compared to the other influenza vaccine group for influenza virus strains were 1414 (95% CI: 1333-1500) for A/H1N1, 1380 (95% CI: 1310-1454) for A/H3N2 and 1216 (95% CI: 1163-1270) for B/Victoria. The GMR of mRNA-1083 compared to Moderna’s currently authorized COVID-19 vaccine for the SARS-CoV-2 Omicron XBB.1.5 variant was 1308 (95% CI: 1219-1404).

Immunogenicity was also tested against the B/Yamagata strain of influenza, and mRNA-1083 met non-inferiority criteria in both age cohorts. Since the B/Yamagata strain has disappeared from circulation, WHO has recommended a trivalent composition for the influenza vaccine, without including B/Yamagata, for the 2024/2025 vaccination season. mRNA-1083 showed an acceptable tolerability and safety profile. The majority of adverse reactions reported were grade 1 or 2 in severity, consistent with the licensed vaccines used in the study. The most common solicited adverse reactions were injection site pain, fatigue, myalgia, and headache.

TAGS: FLU, FLU VACCINE, COVID-19, ANTI-COVID-19 VACCINE, MODERN, MRNA VACCINES