Biologics

Senators Release 2021 Woodcock Email on Covid-19 Concern

Two Republican senators have released a 5/2021 email from then-acting FDA commissioner Janet Woodcock in which she raised concerns about reports of unexplained adverse events that appeared following Covid-19 vaccination and urged federal health officials to consider conducting a study.

Sens. Ron Johnson (R-WI) and Rand Paul (R-KY) say the email to Anthony Fauci and then-NIH director Francis Collins, Woodcock said she had received reports directly from individuals, including health care professionals, describing adverse events following vaccination. She wrote that the symptoms did not form a distinctive syndrome and often could not be readily quantified or evaluated using standard laboratory tests.

Woodcock questioned whether existing vaccine safety-monitoring systems could identify the reported problems, according to a release from the lawmakers. She wrote that the events were not the type that the Vaccine Adverse Event Reporting System (VAERS), CDC's population-based active surveillance, or FDA's Biologics Effectiveness and Safety System would necessarily detect.

Woodcock said she believed the government should conduct a study, adding, “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.”

Fauci forwarded Woodcock's email to Collins the following day, writing that “We cannot ignore her” and suggesting that CDC officials, including then-CDC director Rochelle Walensky, be consulted. The senators said it remains unclear from the material they reviewed whether Walensky was ultimately consulted.

Johnson and Paul said the email raises additional questions about what FDA and other federal officials knew about potential vaccine safety signals in 2021 and how those concerns were investigated.

The senators also linked Woodcock's concerns to separate allegations involving FDA's analysis of VAERS data. They cited an April 2026 Senate staff report alleging that FDA officials had been warned that an algorithm used to analyze VAERS data could mask potential safety signals. Those allegations were not established by Woodcock's May 2021 email itself.

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Overton Confirmation Remains Uncertain After Senate Hearing

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