FDA blindsides Moderna with refusal to review flu vaccine application: ‘We're pretty confused'

Core Viewpoint - The FDA's refusal to review Moderna's application for its new mRNA flu vaccine has left the company's president in shock, citing confusion over the agency's decision regarding trial adequacy and control measures [1][6][7]. Group 1: FDA's Decision - The FDA stated that Moderna's application lacked an "adequate and well-controlled" trial, specifically not comparing the new vaccine to the best-available standard of care at the time of the study [2][9]. - The FDA indicated that the trial should have used a high-dose flu vaccine as a comparator, particularly for individuals over 65, as these are considered more effective for older adults [10][11]. - The FDA's letter did not express concerns about the safety or efficacy of the vaccine, but emphasized that the trial design did not meet their guidelines [6][9]. Group 2: Moderna's Response - Moderna's president expressed surprise and confusion over the FDA's decision, noting that the company had previously discussed trial designs with regulators and received written confirmation that their approach was acceptable [5][9]. - The company reportedly invested over a billion dollars in the clinical trial, which involved more than 40,000 participants and reached the pivotal Phase 3 stage [5][14]. - Moderna warned that the FDA's decision could deter future investments in new medicines and cures, suggesting a significant impact on innovation in the pharmaceutical industry [6]. Group 3: Implications and Reactions - The Health and Human Services spokesperson criticized Moderna for not following FDA guidance, stating that the trial exposed older participants to increased risks by using a substandard control [11][12]. - The recent policy changes under Health and Human Services Secretary Robert F. Kennedy, Jr. have led to the termination of nearly $500 million in federal funding for mRNA vaccine development, affecting multiple companies including Moderna [12][13]. - The decision has drawn criticism from health officials, who argue that it undermines the potential of mRNA vaccines in pandemic preparedness [13].