Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

Moderna has shared positive late-stage results for its investigational combination vaccine against influenza and COVID-19. The ongoing phase 3 trial has been evaluating the candidate, mRNA-1083, in two age-group cohorts of approximately 4,000 adults each. One cohort has been comparing mRNA-1083 to Sanofi’s enhanced Fluzone HD flu vaccine co-administered with Moderna’s standalone COVID-19 vaccine Spikevax in adults aged 65 years and older, while the other has been comparing the combination vaccine to GSK’s standard dose Fluarix flu vaccine in adults aged 50 to 64 years, also given alongside Spikevax. The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered comparators, GSK said, adding that mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2 in both groups. The company also reported that mRNA-1083 showed an acceptable tolerability and safety profile, with the majority of solicited adverse reactions consistent with the vaccines used in the trial. The combined vaccine approach could alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices for healthcare providers as well as patients. Stéphane Bancel, Moderna’s chief executive officer, 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.” Bancel added that Moderna is the only company with positive phase 3 data for a flu/COVID-19 combination vaccine. The company said it is planning to present the phase 3 data for mRNA-1083 at an upcoming medical conference and will “engage with regulators on next steps”. The readout comes just over a week after Moderna’s respiratory syncytial virus (RSV) vaccine was approved by the US Food and Drug Administration to protect adults aged 60 years and older against lower respiratory tract disease caused by RSV infection. The vaccine, mRESVIA, is now the only RSV vaccine available in single-dose pre-filled syringes and the first mRNA vaccine to receive approval for a disease other than COVID-19.

Moderna’s combination vaccine against influenza and COVID-19 met the primary endpoints of a late-stage study, eliciting a higher immune response than comparator shots used in the trial. CEO Stéphane Bancel said on Monday "we are very delighted about the results,” as they position Moderna as “the only company with a positive Phase III flu and COVID combination vaccine.”The jab, dubbed mRNA-1083, comprises components of Moderna’s vaccine candidate for seasonal flu mRNA-1010 and its next-generation COVID-19 shot mRNA-1283.The study consisted of one group of adults 65 years and older who received mRNA-1083 or separate doses of Sanofi’s flu vaccine Fluzone HD and Moderna’s currently licensed COVID-19 jab Spikevax. The second group, comprising adults ages 50 to 64, received mRNA-1083 or separate shots of GSK’s flu vaccine Fluarix and Spikevax.Results showed that the immune response from a single dose of mRNA-1083 was non-inferior to the co-administered vaccines, eliciting significantly higher immune responses against the H1N1, H3N2 and B/Victoria flu strains, as well as against SARS-CoV-2. Bancel suggested that the better performance compared to Spikevax was likely because mRNA-1083 has been designed to combat more recent variants of the coronavirus.Moderna added that mRNA-1083 had an acceptable tolerability and safety profile in the study, with the majority of adverse reactions being Grade 1 or 2 injection-site pain, fatigue, myalgia and headache. The company plans to present the data at an upcoming medical conference and engage with regulators on next steps. Meanwhile, Bancel suggested that mRNA-1083 could be launched next year and be more widely available in 2026.Earlier this year, Moderna reached an agreement to bring in external funding of up to $750 million from Blackstone Life Sciences to support development of its mRNA-based flu vaccines, including mRNA-1010, as well as other combination shots to provide protection against flu, respiratory syncytial virus (RSV) and COVID-19. The drugmaker recently gained FDA approval for its RSV vaccine mRESVIA, marking the first step in its commercial efforts beyond COVID-19.For further analysis, read Spotlight On: Will Moderna’s RSV vaccine help to deliver on the promise of mRNA?