Newly released government communications show that a top Food and Drug Administration official raised concerns with Dr. Anthony Fauci about reports of health problems following COVID-19 vaccination in May 2021, warning that existing surveillance systems might not be capable of detecting what was happening.
Republican Sens. Ron Johnson of Wisconsin and Rand Paul of Kentucky released excerpts Sunday from government communications recovered from Fauci’s government-issued cellphone. Among them was a May 27, 2021, email from Dr. Janet Woodcock, who was serving as acting FDA commissioner at the time.
Woodcock wrote to Fauci and then-National Institutes of Health Director Francis Collins about reports she said she was receiving from individuals, including healthcare professionals, describing health problems occurring after COVID-19 vaccination.
“The symptoms do not fit together into a distinctive syndrome and most are not easily quantifiable or evaluated with standard laboratory testing,” Woodcock wrote.
Her concern went beyond the reports themselves. She questioned whether the federal government’s existing vaccine-monitoring systems were equipped to identify such cases.
“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,” she wrote.
VAERS, the Vaccine Adverse Event Reporting System, accepts reports of health events occurring after vaccination. A VAERS report by itself does not establish that a vaccine caused the reported condition or death, and the system’s data require further investigation to determine whether a causal relationship exists.
Woodcock suggested that a study was needed to examine the reports more closely, while expressing doubt that vaccine manufacturers would support such an effort.
“I doubt the industry would support, for obvious reasons,” she wrote. “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’s response came the following day.
“We cannot ignore her,” he wrote to Collins.
Fauci suggested that the matter be discussed with Dr. Rochelle Walensky, who was then director of the Centers for Disease Control and Prevention. Johnson and Paul said in their release that it remains unclear whether Walensky was ultimately consulted about Woodcock’s concerns.
The senators also focused heavily on vaccine safety data available at the time. Their release said that by the date of Woodcock’s email, VAERS contained 440,025 worldwide adverse-event reports associated with COVID-19 vaccination and 8,650 death reports, including 3,350 deaths reported as occurring within two days of vaccination.
Those figures describe reports submitted to VAERS, not confirmed vaccine-caused injuries or deaths. The senators nevertheless argued that the volume of reports should have prompted greater scrutiny.
Johnson and Paul also connected Woodcock’s email to an earlier dispute inside the FDA.
According to their release, Dr. Ana Szarfman warned Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in March 2021 that the algorithm being used to evaluate VAERS data was masking potential safety signals.
The senators said Szarfman subsequently used a different algorithm in monthly data runs and identified dozens of potential signals, including sudden cardiac death, pulmonary infarction, cerebral artery occlusion, basal ganglia stroke, agonal rhythm and Bell’s palsy.
“Unfortunately, FDA officials ignored Dr. Szarfman and the safety signals, told her to cease and desist, and continued to use the algorithm they knew was masking safety signals,” Johnson and Paul’s release alleged.
That characterization is the senators’ account of the internal FDA dispute and does not, on its own, establish that the listed medical conditions were caused by COVID-19 vaccines.
The lawmakers further noted similarities between symptoms discussed by Woodcock and cases examined by NIH researcher Dr. Avindra Nath. That led them to question what Woodcock knew about other federal investigations when she sent her May 2021 email.
“Was Acting Commissioner Woodcock aware of Dr. Nath’s diagnosing and treatment of COVID injection injuries at NIH and/or what senior FDA officials had been told and shown about safety signals when she wrote her May 27, 2021 email?” the senators asked. “If so, why did she hide that knowledge from the public? If not, why was she kept in the dark?”
The newly released correspondence does not answer those questions. What it does establish is that by late May 2021, the acting head of the FDA had personally raised concerns with Fauci and Collins about post-vaccination health reports that she believed might be difficult for existing federal surveillance systems to detect — and Fauci responded that her warning could not be ignored.
