The U.S. Food and Drug Administration (FDA) has stated that it will not recall the Pfizer-BioNTech COVID-19 vaccine despite the presence of an undisclosed DNA sequence that leaves behind fragments.
According to an FDA spokesperson, with over a billion doses administered, there have been no identified safety concerns related to the residual DNA. The FDA maintains that the available scientific evidence supports the safety and effectiveness of the mRNA vaccines.
However, the FDA did not provide specific evidence to substantiate its position. The agency’s response came in light of inquiries regarding the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech shot. The Epoch Times has submitted a Freedom of Information Act request to ascertain when the FDA became aware of this sequence and from whom. The FDA declined expedited processing, citing a lack of “compelling need” for urgent disclosure.
Several international agencies, including Health Canada, have independently confirmed the presence of the DNA sequence, raising questions about why it was not highlighted in regulatory filings by BioNTech. Both BioNTech and Pfizer have not provided responses to these inquiries.
The discovery of the inclusion was first made by Kevin McKernan, a former researcher and team leader for the MIT Human Genome Project. McKernan emphasized the need for thorough investigation, stating that without a concerted effort to examine, nothing will be found.
Dr. Robert Malone, a vaccine expert whose work has been referenced by Pfizer, along with other scientists, has voiced concerns about the inclusion of the SV40 DNA sequence. Dr. Malone asserts that this inclusion renders the Pfizer-BioNTech shot “adulterated” and contends that it should be subject to a recall according to federal law.
Federal law allows the FDA to test drugs suspected of adulteration and, if they fail to meet certain standards and pose a health hazard, mandates the FDA to advise the manufacturer to issue a recall. If the manufacturer fails to comply, “seizure should be considered,” as stated by the law.
Dr. Malone contends that the FDA has not fulfilled its regulatory duties in this matter. He asserts that a rigorous assessment of the associated risks should have been conducted proactively, which he believes has not occurred.
The European Medicines Agency (EMA) explained that SV40 sequences are commonly used in biotechnology for the manufacturing of biological active substances, primarily to enhance gene expression. Pfizer considered this sequence to be non-functional, according to the EMA.
However, testing has revealed residual DNA, which has raised concerns among scientists. David Wiseman, a former Johnson & Johnson scientist, expressed worry that these residual DNA fragments could potentially integrate into a person’s genome. If this occurs, it could disrupt gene regulation and potentially lead to oncogenesis, the process that can lead to cancer.
Phillip Buckhaults, a professor of cancer genomics, conducted tests on vials of the Pfizer-BioNTech vaccine and detected DNA. He raised concerns about potential serious side effects, including death from cardiac arrest. Buckhaults has urged regulators to conduct further testing on the vaccine to ensure its safety.
In light of these findings, there are calls for a thorough safety review and a more detailed examination of the Pfizer-BioNTech COVID-19 vaccine’s composition.