A newly released email has revealed that former Food and Drug Administration (FDA) head Janet Woodcock urged Dr. Anthony Fauci and Dr. Francis Collins to use federal research funds to investigate reports of COVID-19 vaccine side effects. Despite her request, the study was never initiated, raising questions about the response of federal health agencies to vaccine safety concerns during the mass vaccination campaign.
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The disclosure comes as scrutiny continues over how agencies such as the FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) monitored and addressed reports of adverse events following COVID-19 vaccination. The adequacy of existing surveillance systems and the willingness of officials to pursue independent research have become central issues in ongoing congressional investigations.
Woodcock, who was leading the FDA at the time, reached out to NIH leadership in May 2021 after receiving numerous reports from healthcare professionals about adverse events following COVID-19 vaccination. In her email, she described the symptoms as difficult to categorize and not easily measured with standard medical tests. She also highlighted that many patients felt their complaints were not being taken seriously or studied by federal agencies.
"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."
— Janet Woodcock, then-FDA head
Woodcock argued that research should proceed even without support from the pharmaceutical industry. She warned, "if you let a problem fester, then it will come back to bite you later and you are not prepared." According to Woodcock, the existing surveillance systems at the FDA and CDC were not sophisticated enough to detect or describe some side effects. She specifically named the Vaccine Adverse Event Reporting System (VAERS) and the FDA's Biologics Effectiveness and Safety (BEST) system as insufficient for capturing certain types of problems being reported.
Woodcock’s Warning and Agency Response
In her email, Woodcock emphasized that the types of adverse events being reported would not be captured by current safety monitoring tools. She called for independent studies, separate from those run by vaccine manufacturers, to address gaps in understanding and to help restore public trust in the vaccination process.
Dr. Fauci, then director of the National Institute of Allergy and Infectious Diseases (NIAID), acknowledged Woodcock’s concerns in a message to Dr. Collins, who was then NIH director. Fauci wrote, "We cannot ignore her. We should probably bring in CDC and see what Rochelle [Walensky] thinks." Walensky was serving as CDC director at the time. However, it remains unclear whether Walensky was ever consulted or if any follow-up action was taken by the agencies involved.
Despite Fauci’s control over approximately $5.5 billion in research funding as NIAID director, there is no evidence that NIH conducted the type of study Woodcock requested. The lack of action has fueled criticism from lawmakers and patient advocates who argue that more should have been done to investigate and address reports of vaccine side effects.
Congressional Oversight and Missed Studies
The issue resurfaced after Republican Sen. Ron Johnson of Wisconsin released the email as part of an ongoing investigation into the federal government’s handling of vaccine safety monitoring. Johnson’s office noted that the lack of follow-up on Woodcock’s request remains unresolved. An earlier report by Johnson also revealed that Peter Marks, then director of the FDA’s Center for Biologics Evaluation and Research, dismissed warnings from a safety data expert. The expert had cautioned that FDA systems could be missing statistically significant side effects, but Marks argued that such analysis could "create erroneous conflicts that feed in to anti-vaccination rhetoric."
When Republicans regained control of the Senate, Sen. Rand Paul of Kentucky became chair of the Homeland Security and Government Affairs Committee, with Johnson leading its chief investigative subcommittee. Both senators have sought testimony and records related to vaccine safety monitoring, focusing on whether federal agencies adequately investigated reports of adverse events and whether improvements to surveillance systems are needed.
Lack of Response from Key Officials
Fauci and Collins did not respond to requests for comment about Woodcock’s email or the absence of a follow-up study. Marks, who is now at pharmaceutical company Eli Lilly, and Woodcock, who now serves on the board of patient advocacy group Every Cure, also did not provide immediate responses to inquiries.
Woodcock, who spent nearly four decades at the FDA and was known for her connections to both the pharmaceutical industry and patient advocacy groups, appeared to recognize the importance of independent research into vaccine side effects beyond what was captured in clinical trials. Her warning highlighted the need for federal agencies to address gaps in surveillance and research, particularly as patient complaints continued to surface.
The question of whether federal agencies will address these gaps in vaccine safety monitoring and research remains open. Lawmakers and patient advocates continue to call for greater transparency and independent investigation into reports of adverse events, as the debate over vaccine safety and public trust in federal health agencies persists.
