Comment from Anonymous

Docket ID: FDA-2026-N-4162 Document Title: Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) manufactured by Moderna TX Inc. Submitted By: Anonymous To the Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), I am writing to submit formal public comments regarding the Biologics License Application (STN 125869/0) for MFLUSIVA (Influenza Vaccine, mRNA), manufactured by Moderna TX Inc. We are deeply grateful for the opportunity to have the public's views placed formally on the record through this open regulatory process. It is vital that administrative decisions of this magnitude are informed by diverse, independent perspectives. While the pursuit of agile manufacturing platforms is an understandable administrative goal, the committee must rigorously weigh these technological changes against established safety baselines and the specific physiological vulnerabilities of the American public. Of primary concern is the clinical data regarding the reactogenicity of the proposed mRNA/LNP platform compared to traditional, time-tested influenza vaccines. Decades of traditional flu vaccination have provided public health with a massive, predictable, and highly stable safety data baseline. In contrast, published Phase 3 clinical data for this mRNA platform reveals significantly higher rates of both local and systemic adverse events (reactogenicity) compared to standard-dose comparators. 1. Reactogenicity and the Vulnerable Endothelium The explicit design of lipid nanoparticles (LNPs) requires them to act not just as passive delivery vehicles, but as highly immunogenic adjuvants. A growing body of independent clinical literature over the last 15 years highlights that the pro-inflammatory cascades and complement activation associated with systemic LNP administration can place acute stress on the vascular endothelium. For the millions of Americans living with underlying autoimmune conditions, hyper-reactive immune systems, or baseline vascular vulnerabilities—such as the 20+ variations of vasculitis—a formulation with twice the reactogenicity of a traditional vaccine poses a clear clinical dilemma. It is a profound irony to see institutional comments leveraging the vulnerability of immunocompromised and vasculitis patients to advocate for the rapid approval of MFLUSIVA. For individuals whose vital organs are already threatened by baseline vascular inflammation, a highly reactogenic formulation is precisely the type of medical intervention that requires extreme caution, not accelerated adoption. 2. Preserving Long-Term Safety Standards Traditional egg- and cell-based influenza vaccines have provided the global population with an incredibly well-characterized, predictable safety profile for generations. Before the FDA replaces or supplements these stable options with an mRNA/LNP platform carrying a significantly higher reactogenicity profile, this committee must demand exhaustive, long-term safety data focused explicitly on endothelial health, vascular inflammation, and robust post-authorization safety surveillance. Conclusion and Recommendation to the Committee Innovation should never come at the cost of consumer tolerability or baseline safety. We urge the committee to prioritize the physical well-being of everyday citizens over corporate scalability, and to maintain the highest possible safety thresholds for routine seasonal prophylaxis. Thank you for your time, your service, and your rigorous dedication to public health safety. Anonymous