Image: Wikimedia Commons (Sen. Ron Johnson)
Officials at the Food and Drug Administration were well aware of serious safety issues associated with COVID-19 shots in early 2021, yet they intentionally overlooked these concerns.
During a Senate hearing on April 29, at minute mark 17:14, a bombshell interim report was made public by Sen. Ron Johnson (R-Wisconsin), who serves as the Chairman of the Permanent Subcommittee on Investigations (PSI). The 39-page document is titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Signals.”
In the hearing, Sen. Johnson challenged listeners to “determine for yourself how the title is as accurate as it is incriminating.” He said the report includes “evidence of how federal health officials avoided creating a paper trail to prevent transparency and public disclosure in discussing how they’ve been warned of a major limitation of the FDA’s data mining system.” Because of this hearing, indisputable evidence has now emerged that FDA officials were concealing what they already knew.
Thanks to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Sen. Johnson said, “a clear picture of an obvious cover-up by federal health officials.”
Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals, PSI Hearing 4.29.26 https://t.co/eKJf9LoPeQ
— Senator Ron Johnson (@SenRonJohnson) April 29, 2026
The report indicates, “Documents produced by the Department of Health and Human Services (HHS) to the Permanent Subcommittee on Investigations (PSI) show that beginning in early 2021, Dr. Ana Szarfman, who at the time was a senior medical officer and safety data mining developer at the Food and Drug Administration (FDA), used an updated data analysis technique that identified dozens of statistically significant safety signals for adverse events associated with the COVID-19 vaccines.”
She promptly communicated her findings to other FDA officials, including those tasked with monitoring COVID-19 shot safety, but her concerns were largely disregarded, and she was eventually—or conveniently—instructed to cease her data analyses.
Senior officials at the FDA were aware of statistically significant safety signals indicating an increased risk of adverse events. These included acute myocardial infarction associated with the Moderna and Pfizer-BioNTech COVID-19 shots, non-site-specific embolism and thrombosis related to Janssen (Johnson & Johnson) and Pfizer shots, dementia associated with the Pfizer shot, as well as instances of “Death and sudden death” associated with the Moderna and Pfizer shots.
Instead of alerting the public or pausing the distribution of the shots for further scrutiny, it seems that Biden’s health officials overlooked the statistically significant safety signals revealed by the new methodology and focused more on Dr. Szarfman’s efforts than on her concerning findings.
By May 2021, senior officials at the FDA’s Center for Biologics Evaluation and Research (CBER) instructed Dr. Szarfman to delay her data mining reports on COVID-19 shot safety due to concerns it could “create erroneous conflicts that feed into anti-vaccination rhetoric.”
Despite this directive, Dr. Szarfman persisted in advocating for her data mining method, claiming it was more effective at detecting safety signals—signals that should have been shared with the public.
For instance, even after there was an “unambiguous acknowledgment of the myopericarditis signal, Biden health officials continued to fail to immediately warn the public about the risks of cardiac events associated with the COVID-19 vaccines.” In another example, available resources clearly indicated “higher statistically significant safety signals for acute myocardial infarction.”
According to the report, “Records indicate that FDA did not make any adjustments to its data mining methodology as recommended by Dr. Szarfman.”
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