The FDA declined to accept Moderna’s mRNA influenza vaccine for review, creating fresh regulatory uncertainty for mRNA platforms beyond COVID‑19 and prompting industry concern about shifting agency expectations. STAT’s coverage described a broader chill in the biotech sector as companies reassess regulatory timing and risk for new vaccine modalities. Moderna’s finance team called it too early to determine the impact on its path to cash‑flow breakeven, noting the company will continue to pursue approvals. The decision raises near‑term questions about review standards for novel mRNA applications and how those standards will affect commercial forecasting and development prioritization across vaccine developers.