The vaccine represents one of Moderna’s most advanced candidates outside of COVID-19 vaccines, and is one of several influenza vaccine vaccines being developed by the company.
The company believes the mRNA platform – with flexibility and speed in the manufacturing process and improved efficacy over traditional vaccines – is ‘well-positioned to address the significant unmet need in seasonal flu’.
mRNA-1010 leads portfolio of five influenza vaccines
The Phase 3 trial is expected to enroll around 6,000 adults in the southern hemisphere (A confirmatory efficacy study for the candidates may follow during the northern hemisphere influenza season if required).
The randomized, observer-blind study is designed to evaluate the safety and immunological non-inferiority of mRNA-1010 to a licensed seasonal influenza vaccine in adults 18 years and older. Participants will be randomly assigned on a 1:1 ratio to receive either a single dose of mRNA-1010 or a single dose of a licensed seasonal influenza vaccine as a comparator.
mRNA-1010 is a vaccine candidate that encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the WHO for the prevention of influenza, including influenza A/H1N1, A/H3N2, and influenza B/Yamagata- and B/Victoria-lineages (HA is a major influenza surface glycoprotein that is considered an important target to generate broad protection against influenza and is the primary target of currently available influenza vaccines).
The company, however, also has four other mRNA influenza vaccine candidates. mRNA-1011 and mRNA-1012 include additional HA antigens for broader coverage of circulating influenza A strains, and are in pre-clinical studies.
mRNA-1020 and mRNA-1030 include both HA and neuraminidase (NA) antigens (thus targeting multiple proteins in the influenza virus lifecycle and reducing the potential of viral antigenic escape), and entered Phase 1/2 trials earlier this year.
Meanwhile, Moderna is also developing combination vaccines for COVID-19 and influenza (mRNA-1073) and another that targets COVID-19, influenza and RSV (mRNA-1230).
Moderna set for 3 commercial launches in next 3 years
mRNA-1010 represents the fourth mRNA vaccine candidate for Moderna to begin Phase 3 trials, alongside a COVID-19 booster, RSV and CMV vaccines. The pipeline of advanced candidates could lead to three respiratory commercial launches over the next two to three years, according to Moderna CEO Stéphane Bancel.
“mRNA-1010 is the first of several influenza vaccine candidates we are developing with the aim of iteratively improving traditional vaccines by inducing broad and robust immune responses. We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu,” said Bancel. "Influenza vaccines are a key pillar in our respiratory vaccine strategy that includes the development of combination candidates targeting multiple viruses in a single vaccine, including influenza with SARS-CoV-2 and respiratory syncytial virus.