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Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Exp Med. Dec 20, 2025; 15(4): 113869
Published online Dec 20, 2025. doi: 10.5493/wjem.v15.i4.113869
Synthetic messenger RNA vaccines and transcriptomic dysregulation: Evidence from new-onset adverse events and cancers post-vaccination
Natalia Lidmar Von Ranke, Wei Zhang, Philipp Anokhin, Nicolas Hulscher, Kevin McKernan, Peter Mccullough, John Catanzaro
Natalia Lidmar Von Ranke, Wei Zhang, Philipp Anokhin, John Catanzaro, Development of R and D, Neo7Bioscience, Dallas, TX 75032, United States
Nicolas Hulscher, Department of Epidemiology, McCullough Foundation, Dallas, TX 75032, United States
Kevin McKernan, Development of R and D, Medicinal Genomics, Beverly, MA 01915, United States
Peter Mccullough, Development of R and D, McCullough Foundation, Dallas, TX 75032, United States
Author contributions: Von Ranke NL and Zhang W led the interpretation of results; Anokhin P prepared the datasets for analysis; Hulscher N, McKernan K, and Mccullough P provided scientific support and research oversight; Catanzaro J served as the principal investigator for this study and supervised and conceived the research; all authors reviewed and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Neo7Bioscience SpikeX Institutional Review Board (No. IRB00014606), which is registered with the United States, Department of Health and Human Services. Approval was granted under protocol number Neo7-RB-2024-001 on January 15, 2025.
Informed consent statement: All study participants were informed that the participation is voluntary, involves providing a blood sample for transcriptomic analysis, de-identified data may be used in scientific research and publications. Informed consent was obtained from all subjects involved in the study, and all data were de-identified before analysis.
Conflict-of-interest statement: This study was funded by Neo7Bioscience, which was involved in the study design, data collection, analysis, and manuscript preparation. Natalia Lidmar Von Ranke, Wei Zhang, and Philipp Anokhin, who processed and analyzed the data, receive salary support from Neo7Bioscience. John Catanzaro, who conceived the study and served as Principal Investigator, is the CEO and a shareholder of Neo7Bioscience and also receives salary support from the company. Neo7Bioscience is a privately held biotechnology company specializing in the development of personalized therapeutic peptides. Nicolas Hulscher, who provided scientific input, receives salary support from the McCullough Foundation. Peter McCullough, who provided research oversight, is the founder of the McCullough Foundation but receives no compensation from the organization. The McCullough Foundation is a nonprofit entity dedicated to advancing independent public health research, medical ethics, and evidence-based policy. Kevin McKernan, who also provided scientific support, is the founder, Chief Scientific Officer, and a shareholder of Medicinal Genomics, a company that provides genomic services to the agricultural sector.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
Data sharing statement: Deidentified transcriptomic data was deposited in secure, open-access repositories to advance scientific knowledge, in accordance with institutional and ethical guidelines. The datasets generated and analyzed during the current study are publicly available in the NCBI Gene Expression Omnibus (GEO) under accession code GSE304973 (GEO Accession viewer). Control RNA-seq data used for comparison were obtained from the GTEx dataset (GTEx Portal).
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: John Catanzaro, MD, PhD, Development of R and D, Neo7Bioscience, 2500 Summer Lee Dr, Rockwall, Dallas, TX 75032, United States. john.catanzaro@neo7bioscience.com
Received: September 5, 2025
Revised: October 1, 2025
Accepted: October 24, 2025
Published online: December 20, 2025
Processing time: 105 Days and 12.4 Hours
Core Tip

Core Tip: This study demonstrates that individuals experiencing new-onset adverse events or cancer after messenger RNA (mRNA) coronavirus disease 2019 vaccination exhibit widespread transcriptomic dysregulation. Bulk RNA sequencing revealed hallmarks of mitochondrial dysfunction, systemic inflammation, proteasome and ribosomal stress, and nonsense-mediated decay, with additional genomic instability and epigenetic reprogramming in cancer patients. Notably, myelocytomatosis oncogene activation and heightened immune signaling via toll-like receptors and type I interferons were observed. These findings highlight shared and distinct molecular signatures, underscoring the need for further investigation into long-term mRNA vaccine safety and host variability.