Pfizer says U.S. regulators worked closely with the company on all of its biodistribution studies.
Data on how parts of a Pfizer-BioNTech COVID-19 vaccine spread in the bodies of mice were withheld from regulatory submissions to the U.S. Food and Drug Administration, according to a new comparison of those submissions and similar documents sent to Japanese regulators.
Byram Bridle, who has a PhD in immunology and is an associate professor of immunology and virology at the University of Guelph in Canada, authored the comparison. It was dated Aug. 13 and released on Oct. 4 by Dr. Robert Malone, a vaccine adviser to the U.S. government.
“The findings of this report raise serious questions about the integrity of the health regulatory process during the declared COVID-19 pandemic,” Bridle said in his conclusions.
Pfizer, BioNTech, and the FDA did not respond to requests for comment.
During a September meeting, under questioning by Malone, a Pfizer representative said that its studies of the spread of vaccine elements, known as biodistribution, were done in consultation with the FDA. “Pfizer does not have a further comment other than we did our work in close consultation with the FDA on all our of biodistribution studies that were approved for our licensed product,” the representative said.
Malone told The Epoch Times that the images in the submissions appear to have been manipulated “to hide the fact that the biodistribution was much broader than the initial narrative that was promoted, which is that it stays at the site of injection and draining lymph nodes.”
He added: “That was clearly a lie, and it was a lie that we now know was supported by editing data that were presented to the FDA. And, according to what the Pfizer representative stated, that editing of data was done in cooperation and consultation between Pfizer and the FDA. That is completely unacceptable.”
Edited Data
Pfizer and Moderna did not carry out human biodistribution studies before the FDA cleared their messenger ribonucleic acid (mRNA) vaccines in late 2020. They tested the spread of mRNA in animals.
Pfizer and BioNTech tested a surrogate product containing modified RNA, or modRNA, and luciferase, a bioluminescent enzyme found in fireflies, in mice and rats. The distribution was tracked over nine days, according to documents released by the FDA in 2022 under court order.
“Highest signal was detected at the first time points after immunization at the injection site and the signal declined slowly over time until day 9,” the BioNTech report on the mice study stated. The testing “showed limited drainage to the liver,” but no signal was detected 48 hours after immunization, according to the report.
A single picture from imaging of the mice was included in that section of the report, which was sent to the FDA in 2020. Additional images, with more of the mice bodies included, were provided in filings to Japanese regulators. The images showed that the mRNA spread to the rodents’ kidneys and adrenal glands, Bridle said in his analysis. He also said the luminescence was toned down in the FDA document.
“The image in the FDA’s version of the common technical document appears to be a version of the image from the Japanese document that was manipulated in numerous ways, potentially to discourage discovery that they are one and the same,” Bridle stated. “It was then cropped to hide clear evidence of systemic biodistribution of the modRNA vaccine.”
All of the images sent to American and Japanese regulators cut off at least 25 percent of the mice bodies, including their heads, which prevented any conclusions being made about potential spread to the brain, Bridle said.
