(José Niño, Headline USA) On Wednesday, Sen. Ron Johnson, R-Wis., released an interim report alleging that Biden administration health officials deliberately suppressed a superior algorithm for detecting COVID-19 vaccine safety signals. The report is titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.”
Johnson announced the findings on social media on Wednesday. “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,” he wrote. “They were shown an updated algorithm that signaled serious adverse events, but they refused to use it. Their cover-up jeopardized the health of millions of Americans.”
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
The report centers on Dr. Ana Szarfman, at the time a senior medical officer and safety data mining developer at the FDA who helped develop the agency’s own data mining system. Beginning in early 2021, Szarfman, working with Dr. William DuMouchel — the statistician who developed the FDA’s original Empirical Bayesian data mining algorithm — attempted to get FDA officials to adopt an updated statistical method, according to the Daily Signal’s reporting on the Senate document.
The FDA’s existing approach used Empirical Bayesian data mining, specifically the Gamma Poisson Shrinker model. The central flaw was masking — the volume of adverse event reports from other vaccines obscured signals specific to COVID-19 vaccines. Internal documents obtained by the subcommittee show officials privately acknowledged this method was “mostly useless” for detecting COVID-19 vaccine safety signals.
Szarfman and DuMouchel developed an updated method called the Regression-Adjusted Gamma Poisson Shrinker (RGPS) that corrected for masking. Using this method, they detected “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 states.
Documents obtained by the subcommittee show officials resisted the findings. By May 2021, senior officials in FDA’s Center for Biologics Evaluation and Research directed Szarfman to cease her analysis. Then-CBER Director Dr. Peter Marks called her work a “major distraction” and warned that “the strategy that she is using could create erroneous conflicts that feed in to anti-vaccination rhetoric,” according to Epoch Times reporting on the internal records.
The report notes that FDA officials refused to adopt the improved method, citing concerns about using a “brand new, possibly unvalidated tool in the context of an EUA.” Internal emails show officials recognized their system’s limitations, with one writing that masking “can be driven towards the null by COVID-19 vaccine reports contributing substantially to the comparator group.”
The FDA also restricted access to its analyses. The Daily Signal reported that a CDC official later wrote that “because of the FOIAs we may have asked FDA to stop sending these weekly data-mining outputs” — raising questions about whether the decision to limit distribution was driven by FOIA and congressional oversight concerns rather than data security.
Johnson concluded that “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 interim report was released alongside approximately 600 pages of internal FDA records and can be found here.
José Niño is the deputy editor of Headline USA. Follow him at x.com/JoseAlNino
