A Senate report backed by roughly 600 pages of internal government documents claims that Food and Drug Administration (FDA) officials knew a key safety-monitoring tool was hiding vaccine side effect signals as early as March 2021, and chose to keep using it anyway.
Story Snapshot
- A Senate interim report released April 29, 2026, says FDA officials were briefed that their vaccine safety algorithm was masking serious warning signs, including sudden cardiac death and stroke.
- An FDA doctor developed a better tool that found 25 to 49 hidden safety signals, but a senior official reportedly told her to stop her work, calling it a “major distraction.”
- Internal emails show the Centers for Disease Control and Prevention (CDC) knew about a myocarditis risk by mid-April 2021 but watered down public guidance and never issued a formal health alert.
- Reported deaths in the Vaccine Adverse Event Reporting System (VAERS) jumped from roughly 280 per year before 2021 to over 21,000 in 2021, though VAERS data alone does not prove the vaccines caused those deaths.
What the Senate Report Actually Found
Senator Ron Johnson’s Senate Permanent Subcommittee on Investigations released an interim majority staff report titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.” The report draws on roughly 600 pages of internal FDA and Department of Health and Human Services (HHS) communications obtained through congressional review. The core claim is direct: FDA officials were briefed in March 2021 that their standard data-mining algorithm was statistically masking safety signals in VAERS.
The Doctor Who Found the Hidden Signals — Then Was Told to Stop
FDA medical officer Dr. Anna Scharfman developed an updated statistical tool that she said revealed between 25 and 49 adverse event signals the standard algorithm had missed. Those signals included sudden cardiac death, pulmonary infarction, Bell’s palsy, and strokes. According to the Senate report, FDA official Peter Marks ordered Scharfman to stop her analysis in September 2021, reportedly calling it a “major distraction.” Marks later left the FDA for a position in the private pharmaceutical industry.
The FDA has defended its continued use of the original algorithm, saying it was validated for routine surveillance and that Scharfman’s newer tool, while promising, produced more false alerts. That is a legitimate technical argument. But it does not explain why internal documents, according to the Senate report, show FDA staff worried that the new tool’s findings would fuel “anti-vaccination rhetoric.” That is a political concern, not a scientific one, and it deserves a straight answer under oath.
Myocarditis: What Officials Knew and When They Told the Public
Israeli health officials alerted the CDC on February 28, 2021, to a surge in myocarditis cases among young Pfizer vaccine recipients. Internal CDC and FDA discussions acknowledged the signal by mid-April 2021. Yet no formal Health Alert Network warning went out to doctors. Instead, the agencies posted vague “clinical considerations.” Senator Johnson’s opening statement at the hearing cited internal emails showing CDC staff deliberately softened a recommendation telling myocarditis patients to avoid strenuous activity. Pfizer and Moderna were privately notified about the data. The public was not given the same information at the same time.
The VAERS Numbers and What They Can and Cannot Tell Us
VAERS reported deaths linked to COVID-19 vaccines climbed from roughly 280 per year before 2021 to more than 21,000 in 2021. Senator Johnson himself acknowledged that VAERS data does not prove the vaccines caused those deaths. VAERS is a passive reporting system designed to detect patterns, not confirm causation. A Harvard Pilgrim Health Care study funded by HHS estimated that fewer than one percent of adverse events ever get reported to VAERS, which would mean the actual number of adverse events could be far higher. That gap between reported events and real-world events is exactly why a better monitoring tool matters so much.
***VIDEO RELEASE*** Sen. Johnson Holds Hearing on Biden Health Officials’ Failure to Detect COVID-19 Vaccine Safety Signals – U.S. Senator Ron Johnson
https://t.co/AUwMdZOUvc— ❌Aurora Tracy❌ (@auroratracy0621) July 13, 2026
Critics argue that Senator Johnson has a history of amplifying unverified vaccine claims and that these hearings follow a familiar pattern: congressional pressure, VAERS data, whistleblower testimony, and no peer-reviewed confirmation of the specific signals claimed. That pattern is real, and independent scientific replication of Scharfman’s findings has not yet been published. But the counter-argument runs into a wall: Peter Marks has not given sworn testimony refuting the “cease and desist” claim. The 600 pages of internal communications have not been fully released in unredacted form. And no independent audit of the FDA’s algorithm source code has been conducted. Skepticism cuts both ways. When the people accused of hiding data also control access to that data, “trust the institutions” is not a satisfying answer.
What Has to Happen Next
Three things would either confirm or collapse the Senate’s core claims. First, Peter Marks and Dr. Scharfman need to give sworn testimony before the subcommittee. Second, an independent academic team needs to run Scharfman’s updated algorithm on the raw VAERS data and publish the results in a peer-reviewed journal. Third, the full, unredacted internal communications need to be released. If the FDA’s decisions were purely scientific, that transparency costs nothing. If officials are resisting it, that resistance is itself a signal worth watching.
Sources:
youtube.com, okcfox.com, publichealthpolicyjournal.com, justthenews.com, theohioregister.com
