Moderna Escalates FDA Dispute After Flu Vaccine Review Refusal Amid Revenue Decline
Moderna challenges FDA's refusal to review its mRNA flu vaccine application, citing shifting regulatory expectations. The company reported Q4 revenue of $678 million as COVID vaccine uptake fell 26% in 2025.
Moderna is escalating its standoff with US regulators following the Food and Drug Administration's decision not to review the company's flu vaccine application based on its mRNA platform. The Chief Executive Officer described the FDA as increasingly unpredictable on the analyst call, cautioning that the current regulatory posture could threaten US leadership in innovative medicines.
The FDA said it declined to review the filing because Moderna's studies did not compare the flu shot to the best-available standard of care. The FDA Commissioner stated in a television interview that the outcome should not have been unexpected, arguing the company did not follow the agency's recommendations. Moderna, however, has countered that regulators had previously approved the study design and that expectations have since shifted. The flu shot remains under review in Europe, Canada and Australia.
The Chief Financial Officer acknowledged that with the flu shot's path now uncertain, it is too early to determine whether Moderna can still reach its stated goal of breaking even by 2028. Management has positioned the flu vaccine as central to broadening the company beyond its shrinking COVID franchise.
Moderna reported a fourth-quarter adjusted loss of $2.11 per share, narrower than a year earlier, on revenue of $678 million, exceeding the $625 million average Wall Street estimate as US COVID uptake fell less than expected. The CFO previously said the number of Americans receiving COVID shots dropped 26% in 2025, a smaller decline than the company had projected.
Research and development expenses declined 31% in the quarter as late-stage respiratory trials wound down, reflecting ongoing cost controls. With its RSV vaccine struggling to gain traction and eligibility for COVID vaccines narrowing in the US, investors are now focused on whether Moderna can navigate the current turbulence and advance its oncology collaboration, where late-stage melanoma data could arrive later this year. The first of three Phase 3 trials, Moderna's key 2026 clinical catalyst in melanoma with data due in the second half, faces headwinds.