Moderna has achieved significant progress in its quest to develop an mRNA flu vaccine, with the updated mRNA-1010 version successfully meeting all primary endpoints in a phase 3 trial. This milestone opens the door for a potential launch as early as 2024, according to Moderna CEO Stéphane Bancel.
Compared to GSK’s Fluarix, Moderna’s flu vaccine demonstrated higher antibody levels for all four influenza strains recommended by the World Health Organization (WHO).
Furthermore, it exhibited higher seroconversion rates, indicating the development of specific antibodies against the virus. Importantly, the vaccine’s side effects remained consistent with those observed in previous studies.
Moderna plans to engage with regulators in the near future, aiming to expedite the flu shot’s availability. Bancel emphasized the company’s commitment to expeditious progress, although the exact timeline will depend on guidance from regulatory authorities.
This achievement comes after Moderna’s decision to revise the vaccine’s formula in February following initial setbacks against the influenza B strains. The WHO recommends protection against two influenza A subtypes, H1N1 and H3N2, as well as two influenza B strains, Victoria and Yamagata, in annual flu shots.
When questioned about the secret behind the vaccine’s success, Bancel remained tight-lipped, stating that Moderna has no intention of sharing its proprietary approach with competitors in the mRNA flu vaccine space.
With the phase 3 triumph, an earlier study assessing the initial version of the vaccine in the Northern Hemisphere is concluding. The study, P302, did not accrue sufficient case numbers by the end of the 2022-23 flu season. Moderna hopes to achieve accelerated approval based on a surrogate endpoint by forgoing another flu season.
Moderna’s ambitious goal extends beyond flu prevention. The company aims to create a combination vaccine for both flu and COVID-19, with a potential launch as early as 2025. Furthermore, a triple combination vaccine for COVID-19, flu, and respiratory syncytial virus (RSV) could follow in 2026.
Moderna has submitted a biologics licensing application for a standalone RSV vaccine for older adults to global regulators, with an FDA decision expected in April 2024. Meanwhile, discussions with regulators regarding a phase 2 safety trial for a Zika virus vaccine are ongoing.