The U.S. Food and Drug Administration (FDA) has declined to recall the Pfizer-BioNTech COVID-19 vaccine despite concerns raised about the inclusion of an undisclosed DNA sequence.
The FDA spokesperson emphasized that, with over a billion doses administered, no safety concerns related to the sequence or amount of residual DNA have been identified. The agency maintains that available scientific evidence supports the safety and efficacy of the FDA-approved mRNA vaccines.
However, the FDA did not provide concrete evidence to substantiate its position when responding to inquiries about the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech vaccine. The Epoch Times submitted a Freedom of Information Act query seeking information on when the FDA learned about the sequence and from whom, but the request was denied expedited processing.
Several foreign agencies, including Health Canada, have affirmed the presence of the DNA sequence in the vaccine, echoing concerns raised by outside scientists. Notably, the FDA refused to answer questions about when it became aware of the sequence and whether this information was disclosed by Pfizer or BioNTech.
The inclusion of the SV40 DNA sequence was initially identified by Kevin McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project. McKernan emphasized the need for a thorough examination, expressing skepticism that issues could be identified if not actively investigated.
Renowned vaccine expert Dr. Robert Malone, whose work has been cited by Pfizer, raised major concerns about the potential risks associated with the inclusion of the DNA sequence. He argued that the vaccine should be recalled under federal law, which empowers the FDA to test drugs suspected of adulteration and, if necessary, advise the manufacturer to issue a recall.
Dr. Malone criticized the FDA for not rigorously assessing the risk of toxicity associated with the inclusion, highlighting the agency’s failure to fulfill its core mandate from Congress to prevent adulteration of drugs, medical devices, and food. He insisted that the inclusion of the DNA sequence poses a reasonable risk of toxicity in humans and demands immediate action.
The European Medicines Agency (EMA) defended the inclusion of SV40 sequences, stating that they are commonly present in plasmids used for manufacturing biological active substances. The purpose, according to EMA, is to drive aggressive expression of a gene. However, concerns linger about the residual DNA left behind, with some scientists suggesting potential negative effects.
David Wiseman, a former Johnson & Johnson scientist, expressed concerns that residual DNA pieces could integrate into the human genome, disrupting gene regulation and potentially leading to oncogenesis.
Phillip Buckhaults, a professor of cancer genomics, raised alarms about the regulatory process and urged regulators to conduct thorough safety reviews of the Pfizer-BioNTech vaccine, considering the possible consequences on human health and biology.