The U.S. Food and Drug Administration (FDA) has stated that it will not recall Pfizer’s COVID-19 vaccine, asserting that the presence of an undisclosed DNA sequence that leaves behind fragments is not a cause for concern.
According to an agency spokesperson, the FDA is not obligated to remove Pfizer’s COVID-19 vaccine, or any other COVID-19 shots, from the market. The spokesperson emphasized that with over a billion doses of mRNA vaccines administered, no safety concerns related to the DNA sequence or its amount have been identified. The available scientific evidence supports the conclusion that FDA-approved mRNA vaccines are both safe and effective.
However, the FDA did not provide specific evidence to support its stance.
This statement was issued in response to 10 inquiries regarding the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech vaccine. The Epoch Times has submitted a Freedom of Information Act request to determine when the FDA became aware of this sequence and from whom. The FDA declined to expedite the request, asserting that there is no urgent need to provide this information promptly.
Several international agencies, including Health Canada, have affirmed independent scientists’ findings regarding the presence of the DNA sequence in the vaccine. They have also noted that Pfizer did not highlight this inclusion in its regulatory filings.
The FDA declined to address several questions concerning the sequence, including when the agency first learned of its presence and whether Pfizer informed them.
Both Pfizer and its partner, BioNTech, have not responded to inquiries on this matter.
Kevin McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, was the first to identify this inclusion. He expressed his belief that further investigation is needed to uncover any potential issues.
A number of scientists, including vaccine expert Dr. Robert Malone, who has been cited by Pfizer, have raised significant concerns about this inclusion. Dr. Malone believes that the presence of the SV40 DNA sequence renders the Pfizer vaccine “adulterated” and advocates for a recall.
According to federal law, the FDA has the authority to test drugs suspected of being adulterated. If these drugs fail to meet certain standards and pose a health hazard, the FDA is mandated to advise the manufacturer to issue a recall. If the manufacturer fails to comply, the law allows for the possibility of seizing the products.
Dr. Malone emphasized that immediate action should be taken in cases of adulteration and reasonable risk of toxicity, in line with Congress’ directive to the FDA.
After reviewing the FDA’s response, Dr. Malone concluded that regulators have not fulfilled their responsibilities in this matter.
The inclusion of the SV40 sequence in biotechnology products is not uncommon, as it is used to drive the aggressive expression of a gene. The European Medicines Agency clarified that these sequences are present in plasmids used for the manufacturing of biological active substances. Pfizer considers this sequence a non-functional component of the plasmid.
However, testing has shown that residual DNA is left behind, which has raised concerns among some scientists. They worry that these DNA fragments could potentially integrate into the genome, disrupting gene regulation and potentially leading to oncogenesis.
David Wiseman, a former scientist at Johnson & Johnson, expressed concerns that the residual DNA fragments could potentially become part of a person’s genetic material.
Phillip Buckhaults, a professor specializing in cancer genomics, has tested vials of Pfizer’s vaccine and confirmed the presence of DNA. He has raised alarms about potential consequences for human health and biology, and has called for rigorous safety reviews.
While it’s important to note that this may not necessarily pose a problem, it does raise surprising and concerning questions that regulators should address through a thorough safety evaluation.