Pfizer ‘Chose Not To’ Tell Regulators About SV40 Sequence in COVID Shots: Health Canada Official

A senior Health Canada official says pharma giant Pfizer made a conscious decision not to advise regulators that its mRNA COVID-19 vaccine contained a DNA sequence from the Simian Virus 40 (SV40).

This information appears among multiple emails between staff from key drug regulators, including Health Canada (HC), the U.S. Food and Drugs Administration (FDA), and the European Medicines Agency (EMA). The information was obtained through an access-to-information request.

On Aug. 23, 2023, Dr. Dean Smith, a senior scientific evaluator in Health Canada’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.

Health Canada had obtained confirmation two weeks earlier from Pfizer that SV40 DNA sequences were present in its COVID-19 vaccine.

“I understand that there have been internal discussions at CBER [Center for Biologics Evaluation and Research] regarding the presents [sic] of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Dr. Smith.

“Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”

Dr. Smith added the information had been independently made public in April 2023, via a pre-print study from U.S. scientist Kevin McKernan.

Mr. McKernan, a genomics expert, had found quantities of DNA in the mRNA shots above the regulatory threshold set out by the health agencies. Dr. Smith wrote that the study had resulted in “questions coming to agencies.”

The Epoch Times contacted Health Canada on the matter on July 17, 2023. The first SV40-related email released in the department’s access-to-information package was sent two days later, on July 19.

In that email, Dr. Tong Wu of Health Canada’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.

“Co [Pham, executive director of HC’s Centre for Vaccines, Clinical Trials and Biostatistics] agreed to have an IAS [possibly a reference to an Issue Analysis Summary to evaluate a new regulatory affair] for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote.

As first reported by The Epoch Times last October, Health Canada was not aware of the SV40 enhancer presence. Since then, the FDA and the EMA have both confirmed they also weren’t aware of its presence.

Health Canada has since maintained that the SV40 enhancer/promoter sequence is a “residual DNA fragment” in Pfizer-BioNTech COVID-19 vaccine. “The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” the department has repeatedly said.

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