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.

An anonymous commenter provides a scientific analysis of the pharmacokinetic and biodistribution profiles of mRNA-lipid nanoparticle (LNP) platforms compared to traditional influenza vaccines. They argue that the unique biological behavior of mRNA-LNPs requires high-resolution tracking and specific consideration of molecular composition rather than relying on platform-level bridging data.

The commenter provides a technical, literature-anchored rationale regarding the pharmacokinetic and biophysical differences between mRNA lipid nanoparticle (LNP) platforms and traditional influenza vaccines. They argue that specific factors like biomolecular corona formation, innate immune interactions, and surface properties must be considered in safety and bioequivalence models for mRNA vaccines.

The commenter submitted a technical briefing to the VRBPAC regarding the preclinical biodistribution of lipid nanoparticles (LNPs) used in mRNA vaccines. The document highlights data from various regulatory bodies (EMA, TGA, FDA) showing that these lipid vehicles can distribute systemically and accumulate in ovarian tissues.

The commenter submits a technical notice arguing that the SM-102 LNP platform used in Moderna's MFLUSIVA vaccine causes systemic distribution and transfects non-immune structural tissues, leading to cell-mediated cytotoxic destruction. They urge the committee to conduct a rigorous evaluation of the vaccine's pharmacokinetic and cytotoxic profiles based on these findings.

The commenter provides a technical argument against the safety of the mRNA influenza vaccine by highlighting the biodistribution of SM-102 lipid nanoparticles. They argue that these nanoparticles enter systemic circulation and accumulate in ovarian tissue due to vascular permeability and receptor-mediated cell entry.