By Fred Lucas, The Daily Signal | April 29, 2026
A Senate report alleges that Biden administration health officials failed to act on early warning signs of potential COVID-19 vaccine side effects identified by a Food and Drug Administration scientist.
The interim report from the Senate Permanent Subcommittee on Investigations, chaired by Sen. Ron Johnson, R-Wis., says internal records show officials “ignored” findings from a senior FDA safety data expert using an alternative data analysis method, who identified “dozens of statistically significant safety signals for adverse events associated with the COVID-19 vaccines.”
According to the report, Dr. Ana Szarfman, then a senior medical officer at the FDA, used a modified data-mining approach that accounted for a known limitation called “masking,” which can obscure safety signals in large data sets. She worked with Dr. William DuMouchel, then chief statistician at Oracle.
Her analysis found “49 examples of extreme masking,” including about 25 statistically significant safety signals that were not detected using the FDA’s standard method.
“In other words, by using a methodology that accounted for the masking limitation, Dr. Szarfman and Dr. DuMouchel uncovered approximately 25 statistically significant safety signals for adverse events associated with the COVID-19 vaccines that were not previously detected by FDA’s current methodology, including sudden cardiac death, Bell’s palsy, and pulmonary infarction,” the report says.
The report was made public on Wednesday morning ahead of a subcommittee hearingopens in a new tab on the matter.
Senate PSI Majority Staff Interim Report – April 29, 2026 (FINAL)opens in a new tabDownloadopens in a new tab
Szarfman shared her findings with other FDA officials beginning in March 2021 and continued to present similar analyses in the months that followed, according to the report.
Later analyses identified additional signals associated with COVID-19 vaccines, including “embolism and thrombosis,” “dementia,” and “death and sudden death.”
“However, rather than warn the public or halt distribution of the vaccines for further investigation, records appear to indicate that Biden health officials ignored the statistically significant safety signals uncovered through the new methodology and were more concerned about Dr. Szarfman’s efforts rather than her troubling findings,” the report says.
In April 2021, after Szarfman emailed a data-mining analysis highlighting the limitations of the FDA’s existing system, one senior FDA official wrote to colleagues, “Before we potentially reach out to Ana, we should meet internally—many considerations not suited to email …,” according to the report.
Internal emails cited by the subcommittee show FDA officials expressing concern about how Szarfman’s analyses might be perceived. One senior official warned that her work could “create erroneous conflicts that feed into anti-vaccination rhetoric.”
By May 2021, officials in the FDA’s Center for Biologics Evaluation and Research instructed Szarfman to “hold off on creating and sending data-mining reports and analyses.” Later communications show she was told to “cease and desist.”
Masking occurs, according to the report, when safety signals from one product are “hidden by the presence of other reported vaccines,” potentially delaying the detection of safety concerns.
To address that problem, Szarfman and DuMouchel proposed a newer method known as Regression-Adjusted Gamma Poisson Shrinker, or RGPS, which the report describes as “state of the art” and better able to “unmask hidden signals.”
Internal correspondence cited by the subcommittee shows one FDA official acknowledging that “an absence of a disproportionality alert does not rule out presence of a safety problem” and that results could be “muted” by the sheer volume of COVID-19 vaccine reports.
The report further says FDA officials in 2021 and 2022 reduced distribution of weekly data-mining reports, initially citing “data security reasons.” One Centers for Disease Control and Prevention official later suggested the decision may have been influenced by public records concerns, 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 timing of the decision to stop distributing the weekly data-mining reports “seems particularly suspect,” the report concludes.
“In light of these public and congressional requests, the timing of FDA’s decision to end its distribution of its weekly data-mining reports seems particularly suspect,” the report says. “The notion that Biden health officials took steps to limit its distribution of COVID-19 vaccine safety data in order to avoid more internal review or public scrutiny is completely unacceptable.”
By 2024, according to the report, some FDA officials appeared to acknowledge that the newer method Szarfman advocated was more sensitive. One official wrote that the updated model produced “significantly higher” results for certain adverse events, while another agreed it appeared “way more sensitive” than the existing system.
“FDA officials had ample opportunity to involve Drs. Szarfman and DuMouchel—both experts in data mining—in their safety surveillance efforts, but instead, cast them and their analyses aside,” the report says.
Fred Lucas is senior investigative reporter for the Daily Signal. He is the author of “The Myth of Voter Suppression: The Left’s Assault on Clean Elections.”
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