FDA Responds After Being Urged to Recall Pfizer’s Vaccine Over DNA Fragments

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Dr. Robert Malone and other experts say the COVID-19 shot should be recalled.

The U.S. Food and Drug Administration (FDA) is refusing to recall the Pfizer-BioNTech COVID-19 vaccine, promoting the view that the inclusion of a previously-undisclosed DNA sequence that leaves behind fragments is not of concern.

The FDA is not required to take the COVID-19 vaccine, or other COVID-19 shots, off the market, an agency spokeswoman told The Epoch Times via email.

“With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective,” the spokeswoman added.

The FDA did not provide any evidence to back up its position.

The email came in response to 10 questions about the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech shot.

The Epoch Times has submitted a Freedom of Information Act query to try to unlock when the FDA learned about the sequence, and from whom. The FDA denied expedited processing for the request, claiming there is not a “compelling need” to quickly provide the information.

Several foreign agencies, including Health Canada, have confirmed outside scientists’ assessment that the vaccine contains the DNA sequence. They’ve also said BioNTech did not highlight the inclusion in regulatory filings.

The FDA would not answer a number of questions about the sequence, including when the agency learned about its inclusion and whether it learned about it from Pfizer or BioNTech .

BioNTech and Pfizer have not responded to inquiries.

The inclusion was first identified by Kevin McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project.

“Nothing will be identified if they continue to choose not to look,” Mr. McKernan told The Epoch Times via email.

A number of scientists have said the inclusion raises major concerns, such as having potential for oncogenesis—or a process that leads to cancer—including Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer.

By Zachary Stieber

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