Sen. Ron Johnson: FDA Ignored Early COVID Shot Safety Signals, Internal Records Show
A newly released U.S. Senate investigation is raising concerns that federal health officials were alerted to significant safety signals linked to COVID shots early in 2021—but failed to act and, in some cases, moved to suppress further analysis.
The findings, based on internal FDA records and emails obtained by Wisconsin Senator Ron Johnson’s Permanent Subcommittee on Investigations, are now prompting broader questions about transparency, safety monitoring and informed consent—including in Canada.
“Dozens” of Safety Signals Identified—Then Ignored
According to the Senate report, FDA safety expert Dr. Ana Szarfman used an improved data-mining method that uncovered dozens of statistically significant adverse event signals associated with COVID shots.
Her analysis identified 49 cases of “extreme masking,” revealing approximately 25 safety signals that the FDA’s standard system failed to detect. These signals included serious conditions such as sudden cardiac death, Bell’s palsy, pulmonary infarction, myocardial infarction, embolism and thrombosis, as well as death.
The issue, according to the report, was not a lack of data but the method being used to analyze it. The FDA’s existing system suffered from “masking,” meaning large volumes of reports could obscure real safety signals and prevent earlier detection of potential risks.
Today, I released a report showing that Biden health officials knew that safety signals for COVID-19 injection injuries were being hidden by their VAERS analytic algorithm.
They were shown an updated algorithm that signaled serious adverse events, but they refused to use it.… pic.twitter.com/R5L99g8DiO
— Senator Ron Johnson (@SenRonJohnson) April 29, 2026
A More Effective Method Was Available—But Not Used
Internal records show FDA officials were aware of a more advanced method capable of correcting for this masking problem and identifying hidden risks. Szarfman presented this approach to senior officials in 2021 and shared analyses demonstrating its effectiveness in detecting signals that the standard system missed.
However, the report indicates that senior leadership, including Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, was aware of the analysis yet the improved method was not adopted. Instead, the agency continued relying on an approach known to be less sensitive during a critical period of widespread rollout.
Here is a video compilation from @React19org of Dr. Peter Marks’ comments to people suffering from COVID-19 injection adverse events.
Based on our report, do you think he was being honest with them? pic.twitter.com/4l6KalW0bP
— Senator Ron Johnson (@SenRonJohnson) April 29, 2026
Internal Emails Show Efforts to Halt the Analysis
Rather than expanding the investigation, internal emails reveal concern among FDA leadership about how the findings could be perceived publicly. One official warned the analysis could “feed into anti-vaccination rhetoric,” reflecting sensitivity around how safety data might impact public confidence.
Soon after, Szarfman was instructed to “hold off” on producing further reports, and her work was effectively shut down. Additional communications show that Marks was involved in discussions about the analysis and its implications, while agencies also considered limiting distribution of safety reports due to potential Freedom of Information Act requests.
Signals Were Detected—But Not Communicated
The report indicates that safety signals were identified internally as early as March 2021 and shared within the agency. Despite this, there is no indication these findings were clearly communicated to the public at the time.
Instead, the investigation raises concerns that officials prioritized messaging over transparency, leaving physicians and patients without access to potentially critical safety information during a period when uptake was being actively encouraged.
What This Means for Canadians
Canada relied heavily on the same clinical trial data, regulatory decisions and post-market surveillance approaches as the United States when authorizing and promoting COVID injections. Health Canada and the Public Health Agency of Canada drew on similar global data sources and safety monitoring frameworks in shaping their guidance.
If early warning signals were detected but not fully investigated or disclosed in the U.S., it raises important questions about how similar data may have been assessed—or not communicated—in Canada. For Canadians, the issue is not just what happened in the United States but whether the same gaps in transparency could have affected informed consent at home.
Sources:
U.S. Senate Permanent Subcommittee on Investigations Report led by Sen. Ron Johnson
Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals
CHD’s The Defender “Sen. Ron Johnson: Emails Show FDA Ignored ‘Overwhelming Evidence of Harm’ From COVID Vaccines”
The Daily Signal, “Senate Report: Biden FDA ‘Ignored’ Early COVID-19 Vaccine Safety Warnings”
LegiStorm, Press release from Office of Sen. Ron Johnson
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