Moderna Deprioritizes Flu/COVID Combo Vaccine for Younger Adults Amid FDA Delay

Moderna, the Massachusetts-based biotech company, has announced significant changes to its development strategy for its combination flu/COVID-19 vaccine, mRNA-1083. The company is deprioritizing the vaccine's development for adults aged 18-49 and facing delays in FDA approval for older adults, as part of a broader effort to reduce operating expenses.

FDA Requests Additional Efficacy Data

Moderna's plans for a swift approval of mRNA-1083 have hit a roadblock. The company initially filed for FDA approval using immunogenicity data, aiming for authorization in adults 50 years and older by 2025. However, the FDA has now requested phase 3 efficacy data before granting approval, pushing the targeted approval date into 2026.

This delay affects not only the timeline for older adults but has also led Moderna to reconsider its strategy for younger populations. The company has decided to deprioritize the development of mRNA-1083 for individuals aged 18 to 49 years, focusing instead on the older demographic where vaccine uptake is historically higher.

Market Dynamics and Vaccination Rates

The decision to focus on older adults aligns with current vaccination trends. According to recent CDC estimates, flu vaccine uptake for the 2024-2025 season stands at 36.2% for those aged 18-49, compared to 48.9% for the 50-64 age group and 72.0% for seniors. Similarly, COVID-19 vaccination rates show a stark difference, with only 14% of 18-49-year-olds receiving the 2024-2025 vaccine, versus 44.2% of those 65 and older.

Despite these challenges, Moderna remains optimistic about the potential of its combination vaccine. Stephen Hoge, M.D., Moderna's president, cited market research indicating that around two-thirds of people are likely to prefer a combination product over separate vaccines for flu and COVID-19. Hoge emphasized the convenience and efficiency benefits of the combo shot, stating, "We do believe that the combination product is the majority, for convenience, and ultimately on healthcare systems is much less of a burden."

Financial Implications and Future Outlook

The deprioritization of mRNA-1083 for younger adults is part of Moderna's broader strategy to reduce operating expenses by up to $1.7 billion by 2027. The company reported a 19% decrease in R&D costs to $856 million in the first quarter, attributing the reduction to lower clinical development costs across respiratory programs.

While scaling back on certain respiratory programs, Moderna is increasing investment in other areas, including its individualized neoantigen therapy mRNA-4157 and norovirus programs. The company also announced that the FDA has lifted a hold on its norovirus program, which was paused due to a reported case of Guillain-Barré syndrome.

As Moderna navigates these strategic shifts and regulatory challenges, the pharmaceutical industry watches closely to see how the company's combination vaccine strategy will unfold in the coming years.