Regulatory Collusion and Data Manipulation: What Biodistribution Studies Reveal About the mRNA COVID Shots
A new analysis by Dr. Robert Malone—the original inventor of mRNA vaccine technology—details how regulators and manufacturers failed to meet established safety standards for the COVID-19 mRNA products.
Dr. Malone’s findings focus on biodistribution—how injected materials move from one location to another and persist in the body—and the alleged manipulation of related data submitted to global health authorities.
Key Revelations
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At a recent U.S. CDC Advisory Committee on Immunization Practices (ACIP) meeting, representatives from Pfizer and Moderna admitted that standard biodistribution and pharmacokinetic studies were never properly completed before the shots were tested in humans.
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Pfizer’s representative confirmed that their bio-distribution data had been edited in coordination with the FDA—a clear breach of regulatory independence.
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Moderna, meanwhile, lied outright, claiming it had conducted biodistribution studies on its actual vaccine formulation, a statement later shown to be false.
Canadian Connection: Dr. Byram Bridle
Canadian vaccinologist Dr. Byram Bridle, a viral immunologist from the University of Guelph, was among the first scientists to uncover inconsistencies in Pfizer’s regulatory submissions. In 2021, Dr. Bridle obtained a Japanese regulatory document revealing how Pfizer’s lipid nanoparticles and mRNA didn’t stay in the injection site but instead travelled through the bloodstream, concentrating in the liver, spleen, adrenal glands, lymph nodes, and ovaries.
Dr. Bridle’s ongoing analysis, now cited by Dr. Malone, highlights four instances of apparent data manipulation and scientific fraud in the animal biodistribution studies submitted to regulators:
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Cropped and altered images — Key data showing luciferase (a marker used to trace biodistribution) in organs such as the kidneys and adrenal glands were cropped out of images released by the FDA.
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Redacted data — Graphs that originally showed the persistence of injected material in the body were later redacted to falsely suggest that the mRNA cleared within nine days.
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Suppressed safety data — An initial rat study showing serious toxicity and even death at higher doses was omitted from international submissions.
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Sex-specific effects hidden — Female rats showed spiking accumulation of lipid nanoparticles in multiple organs at 48 hours, yet this crucial data was not disclosed to regulators in Japan.
Malone’s Assessment
Dr. Malone concludes that this pattern of suppression and data manipulation points to active collusion between U.S. regulators (FDA’s Dr. Peter Marks) and vaccine manufacturers to fast-track mRNA products by bypassing international gene therapy safety standards.
He notes that if the shots had been correctly classified as gene therapy products, far more rigorous testing—including genotoxicity and reproductive safety studies—would have been required.
Why It Matters
These findings challenge the early public narrative that the mRNA injections “stay in the arm” and “disappear quickly.” Instead, both Dr. Malone and Dr. Bridle’s analyses indicate systemic distribution and organ accumulation, especially in females, raising urgent questions about long-term safety and regulatory integrity.
You can read Dr. Malone’s full article HERE.
Other references:
Bridle, B. (2025). Report on Pfizer Biodistribution Studies to Highlight Four Instances of Potential Fraud
Demasi, Maryanne (2025). Moderna Misled ACIP on Key Safety Studies
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