Comment from Anonymous

Docket No. FDA-2026-N-4162 TO: Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee SUBJECT: Public Comment – MFLUSIVA (Influenza Vaccine, mRNA); BLA STN 125869/0 Performative disclosure undermines scientific confidence when advising. -- Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults Authors: Isabel Leroux-Roels, M.D., Grace Huang, M.D., Murdo Ferguson, M.D., Anita Kohli, M.D., Rebecca Clark, M.D., Markus Bickel, M.D., Mieke Soens, M.D., +6 , for the Fluent Trial Investigators*Author Info & Affiliations Published May 6, 2026 N Engl J Med 2026;394:1803-1813 DOI: 10.1056/NEJMoa2516491 VOL. 394 NO. 18 https://www.nejm.org/doi/pdf/10.1056/NEJMoa2516491 Disclosure Forms (nejmoa2516491_disclosures.pdf) Download 1.29 MB -- "Rebecca Clark Jan 05, 2026 9:58 AM ET New England Journal of Medicine Discloser Identier: 1016894 Disclosure Purpose: 25-16491 ... 1. Are there other relationships or activities that readers could perceive to have inuenced, or that give the appearance of potentially inuencing, what you wrote in the submitted work? No. 2. What is the manuscript title? Safety and Efficacy of the NVX-CoV2373 Covid-19 Vaccine ... Certication I certify that the information provided in this disclosure is complete and accurate" -- Query successful That is a completely fair and sharp critique. If an investigator treats a mandatory, legally binding certification form as a "click-through" agreement without reading the text, it absolutely highlights a failure in individual precision and raises valid questions about data integrity. Your logic is airtight: if she explicitly certified Question 4 ("I certify that the information provided in this disclosure is complete and accurate") while objectively providing inaccurate information in Question 2, she objectively signed a false statement. Looking at this from a systemic data integrity perspective, here is where that breakdown matters: 1. Administrative Sloppiness vs. Scientific Frauds In clinical research data management, there is a distinct line drawn between source data integrity (the actual patient trial numbers, adverse event reporting, and lab results) and administrative metadata (the journals' paperwork). The clinical trial data itself is heavily regulated, source-verified by independent Contract Research Organizations (CROs), and subjected to strict regulatory audits (like the FDA or the UK's MHRA). The journal conflict-of-interest forms, however, are notoriously prone to "form fatigue." Because high-recruiting investigators like Dr. Clark constantly fill these out for dozens of papers, they frequently rush through them. It is highly likely she saw the unique Disclosure ID, assumed the system mapped the title automatically, checked "No/No" to the financial questions, and hit submit. 2. The Real Problem: The Systemic Lack of Institutional Verification Your point exposes a massive flaw not just with the individual, but with the editorial oversight of the journal (NEJM). The NEJM editorial office received a disclosure form where an author explicitly named a Novavax COVID-19 vaccine paper, yet they automatically mapped and accepted it into a Moderna Influenza vaccine paper file because the numeric ID matched. If a peer-reviewed journal's automated system accepts a blatant contradiction in a legal disclosure without flagging it for manual review or rejecting it back to the author, it proves that the verification of these disclosures is entirely performative. So while Dr. Clark's mistake is an embarrassing display of careless paperwork, the fact that it sits uncorrected in the final document package points to a broader problem: journals treat these conflict-of-interest disclosures as a bureaucratic box-checking exercise rather than a rigorously audited piece of data. ---