THE BREAKDOWN: A newly released staff interim report from the U.S. Senate Permanent Subcommittee on Investigations alleges that federal health officials knowingly ignored advanced data-mining tools that detected early safety signals for COVID-19 vaccines. According to internal documents highlighted in the report, a senior FDA scientist was ordered to stop her independent analysis after her modified algorithms uncovered previously hidden safety signals, including cardiac events and strokes. The report details how officials chose to maintain an outdated tracking system out of concern that the new data might fuel vaccine hesitancy and disrupt federal injection mandates.
The U.S. Senate Permanent Subcommittee on Investigations, led by Chairman Ron Johnson, has released a staff interim report detailing how federal health officials allegedly hid early safety flags for the COVID-19 vaccines.
Titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals,” the report draws on 11 million pages of internal Department of Health and Human Services (HHS) documents to argue that the government prioritized public compliance over transparency as early as the spring of 2021.
At the center of the report is a statistical phenomenon known as “masking.” Because the Vaccine Adverse Event Reporting System (VAERS) was flooded with an unprecedented volume of reports tied to the COVID-19 rollout, the sheer mass of data overwhelmed the FDA’s standard tracking algorithm, Multi-item Gamma Poisson Shrinker (MGPS). This influx effectively drowned out specific safety patterns.
To address this, Dr. Ana Szarfman, a senior medical officer and data-mining developer at the FDA, collaborated with Dr. William DuMouchel—the original inventor of the FDA’s tracking algorithm—to run an updated, regression-adjusted model designed to bypass the masking limitation.
Their updated analysis uncovered “49 examples of extreme masking.” Once the data was adjusted to account for the lopsided baseline, the new system flagged roughly 25 statistically significant safety signals that the standard methodology missed entirely. These unmasked signals included sudden cardiac death, Bell’s palsy, agonal rhythm, and pulmonary infarction.
Rather than alerting providers or the public, top health officials immediately sought to contain the internal findings. Documents show that in April 2021, after Dr. Szarfman emailed an analysis emphasizing the blind spots of the current tracking system, one senior FDA official cautioned his colleagues in an email: “[b]efore we potentially reach out to Ana, we should meet internally – many considerations not suited to email…”
By May 2021, senior leaders within the FDA’s Center for Biologics Evaluation and Research (CBER)—the division tasked with vaccine safety surveillance—officially directed Dr. Szarfman to “hold off on creating and sending data mining reports and analyses.” Internal communications reveal that CBER Director Dr. Peter Marks warned Dr. Patrizia Cavazzoni, the director of the Center for Drug Evaluation and Research (CDER), that Dr. Szarfman’s independent data mining could “create erroneous conflicts that feed in to anti-vaccination rhetoric.”
By September 2021, Dr. Marks informed colleagues that Dr. Szarfman had been formally instructed to “cease and desist” her vaccine work, calling her reports a “major distraction.”
The subcommittee’s report emphasizes that health officials were fully aware of the mathematical flaws in their data system but chose not to fix them. In a September 2021 email, FDA official Dr. David Menschik admitted that tracking scores could be “muted by COVID-19 vaccine reports contributing substantially to the comparator group.”
Years later, in an October 2023 email exchange, FDA official Dr. Narayan Nair acknowledged the persistent masking limitation but defended the agency’s decision to stick with the older method, writing that officials “thought it would be problematic to use a brand new, possibly unvalidated tool in the context of an EUA.” However, by September 2024, internal agency communications between FDA staff confirmed that the newer regression model was “way more sensitive” and yielded significantly higher, more accurate safety alert scores than the system the agency relied upon during the pandemic.
Parallel efforts to manage adverse data occurred at the National Institutes of Health (NIH), according to the congressional findings. In March 2021, Dr. Avindra Nath led an NIH team that diagnosed and treated 23 patients suffering from severe neurological injuries following their shots.
The report states that these study participants were explicitly instructed “not to talk about the study” until the agency finalized its conclusions. Instead of issuing immediate guidance to the broader medical community, the NIH quietly posted its findings on an obscure preprint server in 2022 after participants began speaking out publicly, leaving local medical teams without a protocol to treat similar injuries.
Senator Johnson has sharply criticized both the federal response and the subsequent lack of media coverage regarding the subcommittee’s investigation. Currently, cumulative worldwide data in VAERS shows 1,676,100 adverse events and 39,099 deaths associated with the COVID-19 injections, with nearly a quarter of those deaths occurring within two days of vaccination.
“There has not been a bigger government scandal during my lifetime, and yet even now that we have documented proof of corruption, most of the legacy media refuses to report on it,” Senator Johnson stated, noting that numerous major print and digital news outlets have either declined or ignored requests to publish the subcommittee’s findings.
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