Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut around $1.5 billion from its operating expenses. The biotech disclosed the changes alongside news of a delay to the expected approval of the vaccine in older adults.
Massachusetts-based Moderna filed for FDA approval of its mRNA-1083 combination shot last year. As of February, the mRNA specialist was aiming to win approval in adults aged 50 years and older this year and expand the label to cover younger adults in 2027. Moderna axed both targets in its first-quarter results Thursday.
The biotech has deprioritized the development of mRNA-1083 in people aged 18 to 49 years. Moderna is still working to get the vaccine to older adults, but the process is taking longer than hoped. Having filed for approval using immunogenicity data, Moderna has learned the FDA wants to see phase 3 efficacy data before signing off on the vaccine. The request pushes the targeted approval date back into 2026.
Uptake of standalone COVID-19 and flu vaccines is lowest in the demographic deprioritized by Moderna. As of last month, the Centers for Disease Control and Prevention (CDC) estimated 36.2% of people aged 18 to 49 years in the U.S. had received a flu vaccine for the 2024 to 2025 season. Uptake rose to 48.9% in people aged 50 to 64 years and 72.0% in seniors.
The COVID-19 vaccination data follow the same pattern. Around 14% of people aged 18 to 49 years have received a 2024 to 2025 COVID-19 vaccine, according to the CDC, compared to 44.2% of people aged 65 years and older.
Stephen Hoge, M.D., Moderna’s president, talked up the prospects of the combination shot at an event run by TD Cowen in March. Hoge said Moderna’s market research found around two-thirds of people are likely to prefer the combination product over monotherapy vaccines.
“We do believe that the combination product is the majority, for convenience, and ultimately on healthcare systems is much less of a burden. You can do twice as many injections and take half as much time, half the infrastructure, much more efficient from a storage perspective, all of the above,” Hoge said. “So, for all those reasons, we really do believe the combo is the best.”
Moderna used its first-quarter results to outline its ambition to reduce its operating expenses by up to $1.7 billion by 2027. R&D costs fell 19% to $856 million in the first quarter. Moderna attributed the drop to “lower clinical development costs across respiratory programs due to timing of trial activities and program wind-downs.”
The decline in spending on respiratory programs was partly offset by increased investment in the individualized neoantigen therapy mRNA-4157 and norovirus programs. Moderna said the FDA has lifted the hold it put on its norovirus program in response to a case of Guillain-Barré syndrome. The timing of the phase 3 readout will depend on case accruals.