‘Will Come Back To Bite You’: Top FDA Official Asked Fauci For Vaccine Side Effect Study, Email Shows

A newly released email suggests that the nation’s top vaccine regulator encouraged Dr. Anthony Fauci and Dr. Francis Collins to leverage billions in scientific research dollars to study COVID vaccine side effects — but they never followed through on her request.

In the spring of 2021, Janet Woodcock, then head of the Food and Drug Administration (FDA), wrote to the leaders of the National Institutes of Health — the country’s leading funder of medical science — to encourage a study into reports she had received of adverse events after COVID-19 vaccination. Woodcock had received many of these reports from “healthcare professionals,” she wrote in the email released by Republican Wisconsin Sen. Ron Johnson and obtained from Fauci’s government email.

“The symptoms do not fit together into a distinctive syndrome and most are not easily quantifiable or evaluated with standard laboratory testing,” she wrote in the May 27, 2021 correspondence. “Clearly during mass vaccination you will get a lot of psychological reactions and it is hard to sort these things out. But 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.”

Woodcock said that these studies should be undertaken even if the vaccine makers would not support them.

“I doubt the industry would support, for obvious reasons,” she wrote in the email. “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.”

Woodcock was an FDA official for 37 years and cultivated a reputation for being friendly to the pharmaceutical industry and industry-backed patient groups. Yet she apparently recognized the importance of studying vaccine side effects outside of the context of the pharmaceutical companies’ clinical trials. 

Woodcock warned that the existing safety surveillance systems at both the FDA and the Centers for Disease Control and Prevention (CDC) were not be sophisticated enough to adequately detect and describe some side effects.

“These problems are not the sort that a system like VAERS would be able to detect, or even a more sophisticated population-based active followup [sic] such as CDC has, or a medical record based system such as BEST [an FDA safety surveillance system],” she said.

Despite the roughly $5.5 billion in research dollars that Fauci steered as the director of the National Institute of Allergy and Infectious Diseases, it’s not clear the sort of study Woodcock suggested was ever conducted.

An April investigation by Johnson first revealed that another top FDA official, Center for Biologics Evaluation and Research Director Peter Marks, brushed off warnings from a safety data expert that FDA systems could be inadequately sensitive and missing statistically significant side effects. Marks said the analysis could “create erroneous conflicts that feed in to anti-vaccination rhetoric,” per Johnson’s report.

Fauci and Collins did not immediately respond to requests for comment. An email requesting comment from Marks sent through Eli Lilly, where he now serves as senior vice president of molecule discovery, did not receive an immediate response. An email requesting comment from Woodcock sent through Every Cure, a patient advocacy group with Woodcock on the board, did not receive an immediate response.

Regarding Woodock’s email, Fauci noted to Collins that “we cannot ignore her” and suggested alerting then-CDC Director Rochelle Walensky.

“Janet [Woodcock] asks what we think of this? We cannot ignore her. We should probably bring in CDC and see what Rochelle [Walensky] thinks,” he wrote.

Johnson’s office noted in a press release that it’s not clear whether she ever was.

When Republicans retook control of the Senate in 2025, Republican Kentucky Sen. Rand Paul gained the chairmanship of the key the Homeland Security and Government Affairs Committee (HSGAC) and began the process of compelling testimony and subpoenaing records. Johnson simultaneously also became chair of the HSGAC’s chief investigative subcommittee.