Moderna has announced positive Phase III data for its COVID-19/influenza combination vaccine, mRNA-1083. The investigational combination mRNA vaccine generated statistically significant higher immune responses in relation to the licensed comparator vaccines used in the randomised, observer-blind, active control study among 8,000 adults aged 50 years and older. This development comes less than two weeks after Moderna’s FDA approval of the first mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA, further demonstrating the potential of mRNA technology in combating infectious diseases, says GlobalData.
Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments, “Moderna’s mRNA-1083 combines the mRNA-1010 seasonal influenza vaccine candidate with the mRNA-1283 next-generation Covid-19 vaccine candidate. At this time, mRNA-1083 is poised to be the first Covid-19/influenza combination vaccine and the first mRNA influenza vaccine on the market.”
Moderna reported that a single dose of mRNA-1083 met immunogenicity non-inferiority criteria versus the licensed comparator vaccines. Fluzone high-dose and Fluarix for influenza, and Spikevax for Covid-19. Furthermore, mRNA-1083 generated statistically significant higher immune responses against the influenza strains H1N1, H3N2, and B/Victoria, as well as SARS-CoV-2. The investigational combination vaccine displayed an acceptable safety and tolerability profile, with the most commonly reported adverse reactions being injection site pain, fatigue, myalgia, and headache.
Kurdach continues, “The development of a Covid-19/influenza combination vaccine could be advantageous to patients, as it would decrease the number of injections needed to provide sufficient protection against multiple respiratory illnesses. Likewise, the development of a combination vaccine is strategic for pharmaceutical companies, as successful uptake of the vaccine can translate to significant market shares under multiple indications.”
Key opinion leaders (KOLs) interviewed by GlobalData have expressed positive opinions on the development of a Covid-19/influenza combination vaccine, as well as the advancement of vaccines for infectious diseases due to mRNA technology. mRNA vaccines require a shorter production time, have the potential to incorporate large numbers of antigens, and may therefore be more efficacious than traditional vaccines.
According to GlobalData, there are over 90 mRNA vaccines for infectious diseases in late-stage development (Phases II-III) globally. These include vaccines for Covid-19, RSV, influenza, cytomegalovirus, tuberculosis, malaria, mpox, meningitis, norovirus, shingles, and Lyme disease. Among these are combinations of Covid-19/influenza and Covid-19/RSV.
“If approved, Moderna’s COVID-19/influenza combination vaccine will be an important addition to the vaccines market. The positive Phase III data provides further validation of how mRNA technology is advancing the infectious diseases pipeline,” concludes Kurdach.’
Edits made by EP News Bureau