European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Regulator claims fragments left by sequence are at acceptable levels.

A European regulator confirmed that Pfizer did not highlight 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) explained in an email to The Epoch Times.

The email came after Health Canada told The Epoch Times that sponsors are expected to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer, but Pfizer did not.

Pfizer and BioNTech, its partner, have not responded to requests for comment.

The inclusion of the enhancer in Pfizer’s vaccine was not highlighted because “it was considered to be a non-functional part of the plasmid,” according to the EMA. “They have since clarified this information in response to questions raised by EMA.”

Parts of the SV40 sequence are “commonly present in plasmids used for manufacturing of biological active substances,” according to the EMA, but neither authorities nor Pfizer have explained why the sequence was included in the Pfizer shot.

According to Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, “there is no reason” to include the sequence. He has urged US regulators to recall the vaccine, but they have refused.

Disputed Claims

The DNA sequences, including the SV40 sequence, 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 (EMA) said.

The agency provided no evidence to back up its claim.

“The best independent estimates are that 100-200B fragments of the plasmid exist in each dose,” Kevin McKernan, the microbiologist who discovered the sequence in the vaccine, told The Epoch Times via 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.'”

Earlier this year, an EMA spokesperson stated that there was “no evidence to indicate the presence of SV40… in the formulation of COVID-19 vaccines.”

The EMA has now admitted that their previous statement was incorrect.

On the other hand, 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.”

“We have not seen any reliable evidence of residual DNA exceeding approved/safe levels for” the Pfizer vaccine, it added.

According to Dr. Malone, the standards cited were not intended for the Pfizer and Moderna vaccines, which use modified messenger ribonucleic acid (RNA) technology.

“The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies,” said the scientist. “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.”

Can Fragments Be Mutagens?

Some scientists are concerned because the DNA fragments may act as mutagens or change the DNA sequence in a gene, even though the SV40 sequence in the vaccine does not contain the cancer-causing large T antigen.
“The thing is that the smaller pieces could actually be very significant,” former Johnson & Johnson scientist David Wiseman told The Epoch Times. “They could actually get into your genome, potentially.”

Mr. Wiseman was part of a team that recently discovered residual DNA levels in both Pfizer’s and Moderna’s vaccines.
According to Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at Laval University’s Faculty of Medicine, the danger of the SV40 enhancer being present in the vaccine is its possible integration into a cell’s DNA genome.

“All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person,” that’s what he said.

In response, the EMA stated that “there is no scientific evidence that any of these SV40 fragments can act as insertional mutagens.”

That was denied by Dr. Malone.

“Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos,” he wrote in a reply to a question. “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.”

Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, stated that scientists discovered that SV40 sequences are ideal for gene therapy and that one paper described a rate of insertional mutagenesis with transfection as high as 7% of the modified cells.
“Given the EMA waived all genotoxicity studies, their statement is nothing more than complicit wishful thinking,” Mr. McKernan told the BBC.

This story was contributed to by Matthew Horwood.