The European Medicines Agency said that Pfizer kept the SV40 DNA sequence secretly in the COVID-19 vaccine.
A European regulator has confirmed that Pfizer partner BioNTech did not emphasize a DNA sequence in its COVID-19 vaccine.
“While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence,” the European Medicines Agency (EMA) stated in an email.
Health Canada said in the email that while it expects sponsors to identify sequences like the Simian Virus 40 (SV40) DNA enhancer, Pfizer and BioNTech failed to do so.
Requests for comments from Pfizer and BioNTech have not received a response.
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Because “it was considered to be a non-functional part of the plasmid,” according to EMA, BioNTech did not draw attention to the enhancer’s inclusion in their vaccine. “They have since clarified this information in response to questions raised by EMA.”
Parts of the SV40 gene are “commonly present in plasmids used for manufacturing of biologically active substances,” according to the EMA. However, neither the authorities nor BioNTech have been able to provide an explanation for why the DNA was included in the shot.
Pfizer has referenced the work of vaccination expert Dr. Robert Malone, who told The Epoch Times that “there is no reason” to include the sequence. Although he has pleaded with US authorities to recall the vaccine, they have refused.
The SV40 region is one of the DNA sequences that are “broken down and removed” during the manufacturing process, according to the EMA.
“Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled,” the European Medicines Agency stated.
The claim was not substantiated by any evidence provided by the agency.
“The best independent estimates are 100-200B fragments of the plasmid exist in each dose,” Kevin McKernan a microbiologist who first identified the sequence in the vaccine, said in an email. “The EMA has offered no scientific evidence to make such a claim other than ‘Trust our non-peer reviewed heavily redacted failure in transparency.'”
Early this year, an EMA representative stated that there was “no evidence to indicate the presence of SV40… in the formulation of COVID-19 vaccines.”
The EMA is now admitting that its previous statement was inaccurate.
In a letter to the American Board of Obstetrics and Gynecology, Dr. James Thorp pointed out the risks of the COVID-19 vaccine in pregnancy.
However, the agency stated that it “has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals.”
Additionally, it stated that “we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for” the vaccine developed by Pfizer and BioNTech.
According to Dr. Malone, the Pfizer-BioNTech and Moderna vaccines, which make use of modified messenger ribonucleic acid (RNA) technology, were not intended for use with the standards they are quoting.
“The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies,” Dr. Malone said. “To say that just because we haven’t detected it, or it’s below the level that we normally accept with, say a flu vaccine, is completely irrelevant.”
Fragments Act as Mutagens?
Even after accounting for the fact that the SV40 sequence in the vaccination is not the big T antigen that causes cancer, some scientists express concern about the DNA fragments’ potential to function as mutagens or alter the DNA sequence in a gene.
“The thing is that the smaller pieces actually could be very significant,” said David Wiseman, a former Johnson & Johnson scientist. “They could actually get into your genome, potentially.”
Mr. Wiseman was a member of the team that found evidence of leftover DNA in the vaccines from Moderna and Pfizer.
The risk associated with the SV40 enhancer in the vaccine, according to Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at the Faculty of Medicine at Laval University, is that it could integrate into the DNA genome of a cell.
“All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person,” he said.
“There is no scientific evidence that any of these SV40 fragments can act as insertional mutagens,” the European Medicines Agency (EMA) stated in response to those worries.
According to Dr. Malone, that is untrue.
“Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos,” he wrote in an email. “Such DNA fragments are well known to those skilled in the art to be useful for altering genomic information and genome integrity via both recombination and insertional mutagenesis.”
Former researcher and Massachusetts Institute of Technology Human Genome Project team leader Mr. McKernan pointed out that researchers have discovered that SV40 sequences are ideal for gene therapy and that a study reported a rate of insertional mutagenesis with transfection reaching up to 7% of the altered cells.