Regulator claims fragments left by sequence are at acceptable levels.
Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.
“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) told The Epoch Times in an email.
The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.
Pfizer and its partner, BioNTech, have not responded to requests for comment.
Pfizer did not highlight the inclusion of the enhancer in its vaccine because “it was considered to be a non-functional part of the plasmid,” EMA said. “They have since clarified this information in response to questions raised by EMA.”
The EMA said parts of the SV40 sequence are “commonly present in plasmids used for manufacturing of biological active substances,” but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.
Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, told The Epoch Times “there is no reason” to include the sequence. He has urged U.S. regulators to recall the vaccine.
Contested Claims
According to the EMA, the DNA sequences, including the SV40 sequence, are “broken down and removed” during the manufacturing process.
“Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled,” the EMA claimed.
The agency did not provide any evidence to support the claim.
“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, told The Epoch Times 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.'”
An EMA spokesperson said earlier this year that there was “no evidence to indicate the presence of SV40 … in the formulation of COVID-19 vaccines.”
The EMA is now acknowledging that statement was not correct.
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