Moderna Delays Flu/COVID Vaccine Amid FDA Scrutiny, Cuts Spending Plans

Moderna's approval of its combination COVID-19 and flu vaccine has been delayed by the FDA, which is now requiring additional Phase 3 flu efficacy data before considering clearance, potentially pushing a decision to 2026. In response, Moderna is deprioritizing development of the vaccine for younger adults and focusing on older populations, citing both regulatory requirements and lower vaccine uptake among younger age groups. The company is also implementing significant cost-cutting measures, aiming to reduce annual spending by $1.5 billion as demand for standalone COVID-19 vaccines declines. Despite these challenges, Moderna exceeded first-quarter financial expectations due to expense reductions and unexpected COVID-19 vaccine sales, and remains optimistic about future mRNA vaccine innovations. Industry analysts note that increased regulatory scrutiny and evolving approval requirements are shaping the development and commercialization of new vaccines. Moderna's leadership maintains that their interactions with the FDA remain professional and that the agency's requests are scientifically justified.