Moderna says FDA refuses to review its application for experimental flu shot

Core Viewpoint - The FDA's refusal to review Moderna's application for its experimental flu shot, mRNA-1010, reflects a tightening of vaccine regulations influenced by the Trump administration, despite no identified safety or efficacy issues with the vaccine [1][2][4]. Group 1: FDA's Decision and Moderna's Response - The FDA's decision is inconsistent with prior feedback received by Moderna before the application submission and phase three trials [2]. - Moderna has requested a meeting with the FDA to clarify the path forward regarding the application [2]. - The FDA objected to the study design of the clinical trial, which was previously approved, without citing specific safety or efficacy concerns [2][4]. Group 2: Clinical Trial and Regulatory Context - Moderna's flu shot demonstrated positive phase three data last year, achieving all trial goals, and is considered crucial for developing a combination vaccine for influenza and Covid-19 [3]. - The FDA criticized Moderna's choice to compare its vaccine to a standard approved flu shot, stating it did not meet the definition of an "adequate and well-controlled" trial [5]. - Moderna disputes the FDA's reasoning, asserting that existing FDA rules do not mandate the use of the most advanced vaccine as a comparator in clinical studies [5]. Group 3: Future Expectations and Leadership Comments - Moderna anticipates that the earliest approval for its flu shot could occur in late 2026 or late 2027, pending regulatory reviews in multiple regions [6]. - The CEO of Moderna expressed that the FDA's decision does not align with the goal of enhancing U.S. leadership in innovative medicine development [6].