The vaccine produces a stronger immune response than others.
Compilation
Yesterday Moderna announced that Phase 3 mRNA-1083 trialInvestigational combination vaccine against influenza and Covid-19 has fulfilled its requirements primary endpoints, causing a higher immune response than the authorized comparator vaccines used in the study.
“Combination vaccines can reduce the burden of respiratory viruses on healthcare systems and pharmacies, and offer people more convenient vaccination options that can improve vaccine compliance and provide greater protection against seasonal illness.”“, said Stephane BancelCEO of Moderna. “Moderna is the only company with positive result of the combined phase 3 influenza and Covid vaccine. Building on positive Phase 3 data across our respiratory disease portfolio, we continue to address important unmet medical needs and improve public health.”
“Combination vaccines can reduce the burden of respiratory viruses on health care systems and pharmacies, while also offering people more convenient vaccination options that can improve compliance.”
mRNA-1083 contains components of mRNA-1010, Moderna’s seasonal influenza vaccine candidate, and mRNA-1283, Moderna’s next-generation Covid-19 vaccine candidate. Each study vaccine independently demonstrated positive results in phase 3 clinical trials.
The ongoing Phase 3 clinical trial is a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age groups of approximately 4,000 adults each. One cohort of adults 65 years and older compared mRNA-1083 with Fluzone HD, an improved flu vaccine, and Spikevax, a Covid-19 vaccine currently authorized by Moderna. Another group of adults aged 50 to 64 compared mRNA-1083 with Fluarix, a standard-dose flu vaccine, and Spikevax given together.
In both age cohorts, mRNA-1083 induced a statistically significantly higher immune response against three strains of influenza virus and against SARS-CoV-2.
Immune responses to a single dose of mRNA-1083 were found to be noninferior to co-administered routinely recommended and licensed comparators. In both age cohorts, mRNA-1083 also induced a statistically significantly higher immune response against three strains of influenza virus and against SARS-CoV-2. In the 65 years and older cohort, the overall geometric mean ratios (GMRs) of the mRNA-1083 group compared with the Fluzone HD group for influenza strains were 1.155 for A/H1N1, 1.063 for A/H3N2, and 1.118 for B/Victory. The GMR of mRNA-1083 compared to Spikevax for the Omicron SARS-CoV-2 variant XBB.1.5 was 1.641.
In a cohort of 50 to 64 years of age, GMR of the mRNA-1083 group compared with the Fluarix group for influenza virus strains they were 1414 for A/H1N1, 1380 for A/H3N2 and 1216 for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the Omicron SARS-CoV-2 variant XBB.1.5 was 1.308.
The immunogenicity of this vaccine was also tested against influenza B/Yamagata strain, and mRNA-1083 met criteria for noninferiority in both age cohorts.
Immunogenicity was also tested against influenza B/Yamagata strain, and mRNA-1083 met noninferiority criteria in both age groups. Due to the disappearance of the B/Yamagata lineage from circulation, WHO has recommended a trivalent influenza vaccine composition without B/Yamagata for the 2024/2025 vaccines.
mRNA-1083 showed an acceptable tolerability and safety profile. The majority of adverse reactions reported were grade 1 or 2 in severity and were consistent with the licensed vaccines used in the study. The most common adverse reactions were pain at the injection site, fatigue, myalgia and headache.