The European Medicines Agency (EMA) has confirmed that Pfizer did not highlight a specific DNA sequence, known as the Simian Virus 40 (SV40) DNA enhancer, in its COVID-19 vaccine.
The EMA stated that while the full DNA sequence of the plasmid starting material was provided during the initial marketing authorization application, the SV40 sequence was not specifically highlighted by the applicant.
According to the EMA, Pfizer did not emphasize the inclusion of the enhancer in the vaccine because it was considered non-functional. However, they later clarified this information in response to questions raised by the EMA.
Dr. Robert Malone, a prominent vaccine expert, has questioned the inclusion of the SV40 sequence, stating there is no apparent reason for its presence. He has called for U.S. regulators to recall the vaccine, though they have not done so.
The EMA contends that the DNA sequences, including SV40, are broken down and removed during the manufacturing process. They claim that any fragments of the SV40 sequence that may remain are at very low levels and are routinely controlled.
However, some experts, such as microbiologist Kevin McKernan, dispute this claim. McKernan estimates that there are approximately 100-200 billion fragments of the plasmid in each dose. He criticizes the EMA's assertion, calling it a “non-peer reviewed heavily redacted failure in transparency.”
The EMA spokesperson acknowledges that an earlier statement claiming no evidence of SV40 in COVID-19 vaccines was incorrect. Nevertheless, the regulator maintains that there is no evidence linking mRNA vaccines to adverse events related to the presence of DNA material.
Dr. Malone argues that the standards being cited were not originally intended for vaccines like Pfizer and Moderna's, which utilize modified mRNA technology. He stresses the importance of conducting genotoxicity studies to establish safe thresholds in the presence of these delivery complexes.
Concerns have also been raised about the potential mutagenic effects of the DNA fragments. Some scientists worry that even though the SV40 sequence in the vaccine is not the cancer-causing large T antigen, smaller DNA pieces could still impact the genome. Former Johnson & Johnson scientist David Wiseman suggests these fragments could potentially integrate into the genome.
Patrick Provost, a professor at Laval University, highlights the danger of the SV40 enhancer integrating into a cell's DNA genome, potentially initiating a cancerous process. The EMA, however, asserts that there is no scientific evidence supporting the idea that SV40 fragments can act as insertional mutagens.
Dr. Malone disagrees, noting that short DNA fragments are used in biomedical research to alter genomes. Kevin McKernan adds that SV40 sequences have been found to be optimal for gene therapy, and studies have indicated a significant rate of insertional mutagenesis with transfection.
In light of the waived genotoxicity studies by the EMA, McKernan concludes that their statement is merely wishful thinking and complicity.
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