Comment from Meehan Timothy

I urge the VRBPAC and FDA not to recommend approval of Moderna’s mRNA flu vaccine (MFLUSIVA / mRNA-1010) for persons 50 years and older at this time. The marginal benefits do not outweigh the higher reactogenicity, and superior protein-based alternatives like Novavax’s demonstrate a clearer path to better public health outcomes. The FDA previously issued a Refusal to File letter for Moderna’s application due to the use of a substandard comparator (standard-dose instead of high-dose or adjuvanted vaccines appropriate for older adults). Now advisers are reviewing largely the same evidence. This inconsistency raises concerns about regulatory priorities. Data comparison highlights the issue: Moderna’s Phase 3 trials showed higher reactogenicity with significantly more solicited local and systemic adverse events. While mostly mild/moderate, events were more frequent and disruptive than with protein platforms. Efficacy gains were modest. In contrast, Novavax’s protein-based trivalent nanoparticle influenza vaccine (tNIV) and COVID-Influenza Combination (CIC, NCT06291857) in adults 65 years and older delivered robust immunogenicity: 2.4-5.7 fold rises in immune responses, comparable or superior to Fluzone High-Dose. Reactogenicity was excellent - over 98 percent of solicited adverse events were mild/moderate, matching authorized comparators, with no new safety signals. Earlier NanoFlu data in seniors also showed strong performance versus standard comparators. The protein plus Matrix-M platform consistently demonstrates data superiority in efficacy signals, durability, and tolerability for older adults. mRNA’s primary advantage appears to be speed to market, not superior safety, efficacy, or overall benefit. Is speed more important than safety? Regulators should prioritize platforms with the strongest evidence of benefit-risk balance, not rush mRNA options while sidelining protein-based candidates that have performed rigorously against best-available comparators. This pattern of favoritism undermines public trust and health. Approve only if superiority on safety and real-world effectiveness against proper benchmarks is definitively shown. Prioritize review of Novavax’s protein-based candidates which offer true single-dose combo potential and cleaner profiles. Thank you for considering this input.