Senate Report Shows That FDA Buried 49 Safety Signals Using a “Tool” They Knew Was Broken.
On May 8, Senator Ron Johnson released a 600-page report on failures in COVID-19 vaccine safety monitoring. On June 3, he held a Senate hearing on the same subject. The hearing record stays open until June 18 — the same day the FDA’s vaccine advisory committee votes on whether to approve Moderna’s new mRNA flu shot.
Most of the coverage has focused on who said what at the hearing. Almost nobody is talking about what’s actually in the report. So let’s lay it out.
The FDA has more than one method for detecting safety signals in its adverse event databases. The one they used — an empirical-Bayesian data-mining tool — is the weaker option. The CDC publicly called it the “gold standard” and used that framing to justify not running Proportional Reporting Ratios on VAERS data.
But the FDA also had access to a method called RGPS — Recursive GPS, developed and run by Dr. Ana Szarfman, a senior FDA scientist. According to the Public Health Policy Journal’s analysis of the Johnson report, Dr. Szarfman’s method found 49 examples of what the report calls “extreme masking” — cases where the standard tool didn’t just miss a safety signal, but where the structure of the method itself buried the signal beneath statistical noise.
Not failed to detect. Actively masked.
More than 20 serious adverse events — myocarditis, anaphylaxis, thrombosis, Guillain-Barré syndrome, pericarditis, stroke — showed up in the RGPS analysis as linked to COVID-19 vaccines. The standard surveillance system never flagged them. They were never reviewed. Never disclosed to the physicians administering the shots or the patients receiving them.
“Extreme masking” — when the surveillance methodology doesn’t just fail to detect a safety signal, but actively buries it beneath statistical noise generated by the method itself.
The FDA had a working fire alarm in the closet. They looked at it. They looked at the broken one on the wall. And they kept using the broken one.
That matters for one very specific reason — informed consent. Every person who received a COVID-19 vaccine during the period these signals were masked made that decision without access to safety information the FDA’s own data contained. The Nuremberg Code requires voluntary, informed consent. You cannot consent to a risk you were never told about. And the FDA’s own Slide 16 — from the pre-authorization briefing — listed the adverse events they anticipated, including myocarditis, including death. They knew what to look for. They had a tool that found it. They used the one that didn’t.
And when people were injured, the system designed to compensate them was rigged from the start. COVID vaccine injuries were routed into the Countermeasures Injury Compensation Program instead of the Vaccine Injury Compensation Program. VICP gives you a judge, legal representation, and a $250,000 death benefit. CICP gives you a government administrator, no lawyer, and a form letter. Out of 14,733 claims filed, 135 received compensation. That’s 1.8 percent. The PREP Act — 42 U.S.C. § 247d-6d — locked the courthouse door before the first dose was administered.
They hid the danger. Then they blocked the remedy, likely because they are shady and immoral, not for any good reason. This is why IoJ is fighting them in court with a HUGE case commencing and just sent the summons off to start the legal battle against mRNA experiments, which should NOT have PREP Act immunity because it’s NOT a vaccine and must be taken off the market as illegal EXPERIMENTATION.
And now the same agency, using the same broken monitoring infrastructure for their experimental mRNA bio-agents, is preparing to vote on another mRNA product from the same manufacturer. On June 18, the FDA’s Vaccines and Related Biological Products Advisory Committee meets to consider Moderna’s mRNA influenza vaccine for people over 50. The committee makes a recommendation and the FDA almost always follows it.
The hearing record from Johnson’s investigation closes the same day.
FDA CBER Slide 16 — the list they knew about before the first dose:
FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes Subject to change
From: Steve Anderson, PhD, MPP — Director, Office of Biostatistics & Epidemiology, CBER Presented at: VRBPAC Meeting, October 22, 2020 (Source PDF — FDA.gov)
The list:
Guillain-Barré syndrome
Acute disseminated encephalomyelitis
Transverse myelitis
Encephalitis / myelitis / encephalomyelitis / meningoencephalitis / meningitis / encephalopathy
Convulsions / seizures
Stroke
Narcolepsy and cataplexy
Anaphylaxis
Acute myocardial infarction
Myocarditis / pericarditis
Autoimmune disease
Deaths
Pregnancy and birth outcomes
Other acute demyelinating diseases
Non-anaphylactic allergic reactions
Thrombocytopenia
Disseminated intravascular coagulation
Venous thromboembolism
Arthritis and arthralgia / joint pain
Kawasaki disease
Multisystem Inflammatory Syndrome in Children
Vaccine enhanced disease
Anderson did not display this slide to discuss it during the meeting — he clicked past it. The conditions were chosen based on clinical trial data and known science about the vaccine platform. Every one of them has since been reported to VAERS at unprecedented rates.
That’s the full list — 22 adverse event outcomes the FDA anticipated before the first EUA was issued, put on a slide they showed the public for about a second before burying it. Keep reminding people FDA always KNEW THE DANGERS!
IoJ is posting this tonight because there are deadlines most people don’t know about — and two different ways to get on the record.
OPTION 1 — SPEAK DIRECTLY TO THE COMMITTEE
There’s a one-hour open public hearing during the June 18 meeting, from 1:00 to 2:00 PM Eastern. You can speak directly to the committee members. But you have to register by tomorrow.
Here’s what the FDA’s own meeting announcement says:
“Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on June 8, 2026.”
Just email Cicely Reese at CBERVRBPAC@fda.hhs.gov before noon Eastern tomorrow, June 8, with three things — what you want to present, your name and how much time you’re requesting. If too many people apply, FDA runs a lottery. They’ll let you know whether you got a slot by 6 PM Eastern on June 10.
I’m filing mine tonight. I’ve spoken at these meetings before. But more people need to show up for this one. If you have evidence, if you’ve been injured, if someone you love was harmed while this agency looked the other way with a tool they knew was broken — put it on the federal record while the committee sits there and listens.
OPTION 2 — SUBMIT WRITTEN COMMENTS
If you can’t speak or miss the June 8 deadline, you can still submit written evidence.
Go to regulations.gov and search for docket FDA-2026-N-4162. Two deadlines matter here:
Comments submitted by June 12 go directly to the committee members before the meeting. Comments submitted after that but before June 17 at 11:59 PM Eastern are still taken into consideration by FDA, but won’t reach the committee beforehand. After June 17, the docket closes.
Everything you submit becomes part of the public record. If you want to include confidential information, you can mail a paper submission marked confidential to Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Contact for the meeting is Cicely Reese — CBERVRBPAC@fda.hhs.gov or 301-796-9025. FDA Advisory Committee Information Line is 1-800-741-8138. The meeting streams free on YouTube at youtube.com/live/9W18lwG7vD8.
They buried 49 safety signals. They denied 98.2 percent of injury claims. And in 11 days they’re voting on the next one.
Just Us vs the Machine!
Lady Xylie - Interest of Justice
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FINALLY! Thanks for this great reporting. ⭐️⭐️⭐️⭐️⭐️
I can’t believe it. Something comes out of all this. But will it matter? So mind blowing that this even happened. How do these people live with themselves.
My husband and I remain unjabbed. However, hubby got a flu shot in November of 2019 and he got the shingles, had a stroke, and now has dementia. All this in a two year period. Before this.. he was healthy as a horse.