Comment from Anonymous

Subject: Unresolved Site-Level Conflicts of Interest and Shared-Infrastructure Disclosure Omissions in Moderna’s Influenza Vaccine Trial I. Statement of Purpose This submission requests that VRBPAC defer final voting on BLA STN 125869/0. An examination of the Phase 3 data pipeline for Moderna’s seasonal influenza vaccine reveals documented anomalies in conflict disclosures and severe, unreviewed conflicts of interest arising from shared site infrastructure. These factual deficiencies compromise the independence of the trial data. II. Overlapping Protocol Conflicts and Data Integrity The integrity of a double-blind, Phase 3 platform trial relies on the absolute neutrality of the data-collection environment. The data package for this influenza application, however, was generated by clinical research organizations that are simultaneously running multiple distinct mRNA protocols for the same sponsor. The Competing Trial Loop: Multiple high-volume clinical sites responsible for the data in this influenza application are concurrently operating as core recruitment and surveillance hubs for Moderna's active Phase 3 Norovirus mRNA vaccine trial, the NOVA 301 study (NCT06592794). The Confounding Threat: Utilizing the identical localized clinical infrastructure, principal investigators, and tracking staff to run two separate mRNA protocols simultaneously creates an unresolvable conflict of interest. Because the underlying delivery vehicles and corporate endpoints are structurally related, the tracking of reactogenicity, systemic adverse events, and platform-specific symptoms becomes inherently cross-contaminated. The outcome of one protocol directly influences the integrity of the other, making an unblinded, independent evaluation of the influenza data impossible. III. Documented Material Anomalies in Investigator Independence Publicly available disclosure logs for this pivotal Phase 3 study show documented breakdowns in the regulatory oversight layer, illustrating that supposedly independent sites operate as interchangeable administrative nodes: Omission of Active Pipeline Dependency: Multiple clinical trial sites operate as commercial research facilities whose ongoing operations rely heavily on securing consecutive contracts from the sponsor. Investigator Dr. Murdo Ferguson (Colchester Research Group, Truro, NS) certified an official journal disclosure of "no interests to disclose," despite his facility functioning as an active enrollment hub within Moderna's pipeline—transitioning from generating this influenza data to recruiting cohorts for Moderna's Phase 2 Lyme Disease protocol (mRNA-1982). The Shared-Infrastructure Clerical Error: Investigator Dr. Rebecca Clark certified a "no interests" form for this specific BLA while mistakenly entering the manuscript title for an entirely separate competitor product (Novavax’s NVX-CoV2373). This error confirms that the exact same centralized clinical research organization and administrative infrastructure were utilized to process trials for both competing manufacturers, resulting in data and paperwork cross-contamination. This demonstrates that mandatory conflict verifications were executed as unverified administrative chores rather than precise declarations of independent testing. IV. Proposed Regulatory Remedy The combination of overlapping Phase 3 mRNA protocols under the exact same site infrastructure and material omissions in investigator dependencies means the absolute integrity of the primary data pool cannot currently be verified. We urge the committee to protect the regulatory standard by deferring the final approval vote for BLA STN 125869/0 until these documented site-level conflicts and concurrent trial overlaps are formally recognized and reviewed. Anonymous