Press ReleaseNeutral2026-04-29

MEDIA ADVISORY PSI Chairman Johnson Releases Report; Will Hold Hearing on Biden Health Officials’ Failure to Detect COVID-19 Vaccine Safety Signals

Healthcare

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This press release from Senator Ron Johnson (R-WI) was published on 2026-04-29 and titled "***MEDIA ADVISORY*** PSI Chairman Johnson Releases Report; Will Hold Hearing on Biden Health Officials’ Failure to Detec". It focuses on healthcare.

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***MEDIA ADVISORY*** PSI Chairman Johnson Releases Report; Will Hold Hearing on Biden Health Officials’ Failure to Detect COVID-19 Vaccine Safety Signals

WASHINGTON - Today, U.S. Sen. Ron Johnson (R-Wis.), chairman of the Permanent Subcommittee on Investigations, will hold a hearing entitled, "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals." In conjunction with the hearing, the chairman released an interim Majority Staff Report, along with approximately 600 pages of records detailing how in early 2021, Food and Drug Administration ("FDA") officials became aware of a new, "state of the art" data mining method that could better detect statistically significant safety signals for adverse events associated with the COVID-19 vaccines. Rather than adopt the "state of the art" method, Biden health officials continued to employ their older data mining method with known limitations that prevented FDA from detecting adverse events. Key findings from the report include: In 2021, Dr. Ana Szarfman, who at the time was a senior medical officer and safety data mining developer at FDA and helped develop the FDA's data mining system, made senior FDA officials - including Dr. Peter Marks, who led the FDA's Center for Biologics Evaluation and Research - aware of a "superior" data mining method that could adjust for "masking," a known limitation of the FDA's current data mining system that hid signals for adverse events. However, senior FDA officials chose not to utilize this more effective methodology. Between March 2021 and July 2021, Dr. Szarfman shared analyses of COVID-19 vaccine adverse event reports using the more effective methodology with FDA officials that, unsurprisingly, detected far more statistically significant safety signals for adverse events associated with COVID-19 vaccines. One analysis identified "49 examples of extreme masking," including approximately 25 statistically significant safety signals for adverse events that were not previously detected, such as sudden cardiac death, Bell's palsy, and pulmonary infarction. Other analyses Dr. Szarfman shared identified statistically significant safety signals with higher values for adverse events, including acute myocardial infarction associated with the Moderna and Pfizer COVID-19 vaccines, non-site specific embolism and thrombosis associated with the Janssen and Pfizer vaccines, and death and sudden death associated with the Moderna and Pfizer vaccines. FDA officials appear to have been more concerned with Dr. Szarfman's efforts than the alarming findings, with Dr. Peter Marks warning Dr. Patrizia Cavazzoni, the then-Director of the FDA's Center for Drug Evaluation and Research, that Dr. Szarfman's data mining could "create erroneous conflicts that feed in to anti-vaccination rhetoric." FDA officials eventually directed Dr. Szarfman to "hold off on creating and sending data mining reports and analyses." In 2022, FDA and Centers for Disease Control and Prevention ("CDC") officials discussed limiting the distribution of FDA's weekly data mining reports on COVID-19 vaccines with one CDC official writing, "I think that because of the FOIAs [Freedom of Information Act requests] we may have asked FDA to stop sending these weekly data mining outputs." The hearing will be livestreamed on Sen. Johnson's X account , Rumble , and Subcommittee's website . The interim PSI Majority Staff Report can be found here . The records the chairman is releasing today contain minimal redactions for personally identifiable information which was one of the categories of redactions requested by HHS. The records are linked below: Part 1 Part 2 Part 3 Excel Documents ###

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***MEDIA ADVISORY*** PSI Chairman Johnson Releases Report; Will Hold Hearing on Biden Health Officials’ Failure to Detect COVID-19 Vaccine Safety Signals WASHINGTON - Today, U.S. Sen. Ron Johnson (R-Wis.), chairman of the Permanent Subcommittee on Investigations, will hold a hearing entitled, "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals." In conjunction with the hearing, the chairman released an interim Majority Staff Report, along with approximately 600 pages of records detailing how in early 2021, Food and Drug Administration ("FDA") officials became aware of a new, "state of the art" data mining method that could better detect statistically significant safety signals for adverse events associated with the COVID-19 vaccines. Rather than adopt the "state of the art" method, Biden health officials continued to employ their older data mining method with known limitations that prevented FDA from detecting adverse events. Key findings from the report include: In 2021, Dr. Ana Szarfman, who at the time was a senior medical officer and safety data mining developer at FDA and helped develop the FDA's data mining system, made senior FDA officials - including Dr. Peter Marks, who led the FDA's Center for Biologics Evaluation and Research - aware of a "superior" data mining method that could adjust for "masking," a known limitation of the FDA's current data mining system that hid signals for adverse events. However, senior FDA officials chose not to utilize this more effective methodology. Between March 2021 and July 2021, Dr. Szarfman shared analyses of COVID-19 vaccine adverse event reports using the more effective methodology with FDA officials that, unsurprisingly, detected far more statistically significant safety signals for adverse events associated with COVID-19 vaccines. One analysis identified "49 examples of extreme masking," including approximately 25 statistically significant safety signals for adverse events that were not previously detected, such as sudden cardiac death, Bell's palsy, and pulmonary infarction. Other analyses Dr. Szarfman shared identified statistically significant safety signals with higher values for adverse events, including acute myocardial infarction associated with the Moderna and Pfizer COVID-19 vaccines, non-site specific embolism and thrombosis associated with the Janssen and Pfizer vaccines, and death and sudden death associated with the Moderna and Pfizer vaccines. FDA officials appear to have been more concerned with Dr. Szarfman's efforts than the alarming findings, with Dr. Peter Marks warning Dr. Patrizia Cavazzoni, the then-Director of the FDA's Center for Drug Evaluation and Research, that Dr. Szarfman's data mining could "create erroneous conflicts that feed in to anti-vaccination rhetoric." FDA officials eventually directed Dr. Szarfman to "hold off on creating and sending data mining reports and analyses." In 2022, FDA and Centers for Disease Control and Prevention ("CDC") officials discussed limiting the distribution of FDA's weekly data mining reports on COVID-19 vaccines with one CDC official writing, "I think that because of the FOIAs [Freedom of Information Act requests] we may have asked FDA to stop sending these weekly data mining outputs." The hearing will be livestreamed on Sen. Johnson's X account , Rumble , and Subcommittee's website . The interim PSI Majority Staff Report can be found here . The records the chairman is releasing today contain minimal redactions for personally identifiable information which was one of the categories of redactions requested by HHS. The records are linked below: Part 1 Part 2 Part 3 Excel Documents ###