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.