Moderna has shared positive results from a late-stage trial of its influenza vaccine, with mRNA-1010 shown to generate a stronger immune response against all four World Health Organization (WHO)-recommended flu strains compared to GSK’s Fluarix.
Improved immunogenicity was observed across age groups, including older adults, and the company said the candidate was found to be safe and tolerable.
mRNA-1010 was also shown in a separate phase 1/2 head-to-head study to induce a stronger immune response against three of the four WHO-recommended strains compared to Sanofi’s high-dose Fluzone vaccine, and generated an equal response to the comparator against the fourth.
Seasonal flu is an acute respiratory infection caused by influenza viruses, which circulate in all parts of the world.
Although most people can recover within a week without requiring medical attention, flu can cause severe illness among high-risk groups such as young children, older adults, pregnant individuals and those with serious medical conditions.
WHO cites vaccination as the current principal means of reducing or counteracting flu mortality and morbidity burden, but the ever-evolving nature of influenza viruses requires continuous global monitoring and frequent reformulation of vaccines.
The organisation currently recommends that two A subtypes, H1N1 and H3N2, as well as two influenza B strains, Victoria and Yamagata, be targeted in annual flu vaccines.
Moderna outlined in a statement that consultations with regulators on a potential licensing package for mRNA-1010 are “currently ongoing”.
The company is also continuing to advance a variety of flu vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains, as well as candidates incorporating both HA and neuraminidase antigens to target multiple proteins involved in the influenza virus life cycle.
Stéphane Bancel, Moderna’s chief executive officer, said: “Our mRNA platform is working. With [the] positive phase 3 flu results, along with previous results in COVID-19 and respiratory syncytial virus, we are now three for three on advancing respiratory disease programmes to positive phase 3 data.”
Bancel also noted that the company expects to provide data on its COVID-19/flu combination vaccine, mRNA-1083, in the fourth quarter of this year.