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A Small Nonprofit Did What the FDA Would Not

2 hours ago
God reminds us that fidelity to Him will assure our peace and prosperity – LifeSite
Originally posted by: Brownstone Institute

Source: Brownstone Institute

There is a question that has haunted me since the moment I watched institutions fail children during the pandemic: Who will ask the hard questions if the agencies charged with asking them refuse to?

I have spent the past six years trying to answer that question through film, through advocacy, through lawsuits, through grassroots organizing. Now, Restore Childhood is trying to answer it through science.

Restore Childhood is a small 501(c)(3) nonprofit with no pharmaceutical backers, no government grants, and no institutional patrons with interests to protect. We were founded in the crucible of America’s pandemic school closures by parents who watched decisions get made behind closed doors, decisions that cost children years of their lives, while the institutions entrusted with protecting them looked the other way. We documented those failures in 15 DAYS: The Real Story of America’s Pandemic School Closures, a feature documentary examining how and why American schools remained shuttered long after the evidence demanded they reopen. It has now been viewed over 1,000,000 times in its brief run on X.

Recently, we did something else. We funded independent, peer-reviewed scientific research. What that research found should trouble every parent in America.


What the FDA Got Wrong — And What Our Team Got Right

Prior to granting full approval of Moderna’s mRNA-1273 Covid vaccine on January 31, 2022, the FDA conducted a benefit–risk assessment of the vaccine. That assessment concluded that vaccine benefits outweighed the risks of vaccine-attributable myocarditis/pericarditis — even for 18–25-year-old males, the demographic at highest known risk of cardiac injury from the shot.

A team of independent researchers — mathematician Paul S. Bourdon, PhD, our own board member Ram Duriseti, MD, PhD, mathematician H. Christian Gromoll, PhD, immunologist Dyana K. Dalton, PhD, epidemiologist Allison E. Krug, MPH, and bioethicist Kevin Bardosh, PhD — set out to reanalyze that assessment. Their peer-reviewed study, published February 10, 2026 in the journal Vaccines, reaches a starkly different conclusion.

When you account for what the FDA failed to account for, the math changes. Vaccine risks outweighed benefits for the general population of 18–25-year-old males relative to hospitalizations: those caused by vaccine-attributable myocarditis/pericarditis exceeded the hospitalizations prevented via vaccination — by between 8% and 52%, with the team’s most likely scenario showing a 38% excess.


Three Things the FDA Ignored

First, prior Covid infection. By October 1, 2022, the CDC estimated that more than half of 18–49-year-olds had already been infected. The author team estimated (using CDC data) that by January 1, 2022 that approximately 70% of 18–25-year-old males had experienced a Covid infection. Prior infection confers meaningful protection — protection that substantially reduces the benefit of vaccination. The FDA’s model treated the entire population as if every unvaccinated young man were encountering the virus for the first time, dramatically inflating the hospitalizations that vaccination could prevent.

Second, age and sex stratification. The FDA assumed Covid hospitalization rates were uniform across all males aged 18 to 45 — contradicting the CDC’s own modeling, which shows men 30–49 are hospitalized at roughly twice the rate of men 18–29. Lumping these groups together overstated the hospitalization risk facing young men, inflating the apparent benefit of vaccination for precisely the group most endangered by cardiac risks.

Third, incidental hospitalizations. By January 2022, the CDC director had publicly acknowledged that up to 40% of patients hospitalized with a Covid-positive test were there for something else entirely. The FDA’s hospitalization counts did not meaningfully account for this.

On the risk side, multiple independent data sources — from Ontario, England, and the United States — suggested the true rate of vaccine-attributable myocarditis/pericarditis in 18–25-year-old males was significantly higher than what the FDA’s surveillance system reported. Correct for these errors, and the FDA’s favorable benefit–risk conclusion reverses.


This Is What Evidence-Based Medicine Is Supposed to Look Like

The researchers are not contrarians. They are not anti-vaccine. Their model is transparent and reproducible, capable of supporting stratification of vaccine recommendations not only by age and sex but also by prior infection status and comorbidity profile, exactly the kind of individual-level analysis that should inform public health recommendations. The conclusion is not that mRNA vaccination was categorically harmful, e.g., the following is a consequence of the author team’s individual-level analyses: for an 18–25-year-old male without comorbidities who had already been infected with Covid-19, vaccination posed a net harm. For a young man without prior infection, the benefit–risk profile was more favorable for vaccination. This illustrates the type of individual-level analysis that the FDA might have produced before approving the vaccine for mass use in young men.

The author team’s study received no pharmaceutical industry funding and no government grants. It was supported by Restore Childhood — a nonprofit built on small donations from parents who believe someone has to tell the truth. We funded the publication fee for the study to make it open-access; the researchers worked for three years entirely as volunteers–none of them were funded for this work.


This Is Not the Same FDA

I came to this country from the Soviet Union as a six-year-old child. I understand in my bones what it looks like when institutions demand deference they have not earned. I spent the pandemic watching that demand made, of parents, of children, of doctors, of scientists, and I have spent the years since refusing to comply.

But I want to be clear: the institutions that failed us are being rebuilt. Dr. Jay Bhattacharya and his team at the NIH (and now the CDC) are working to restore transparency, replication standards, and independence to American science. Dr. Marty Makary and his team at the FDA are committed to the same. This matters. The problem was never science itself. The problem was the corruption of science by institutional and financial incentives that displaced honest inquiry. Those incentives are being confronted.

Restore Childhood’s mission is to ensure that independent, unfunded research continues in parallel, not because we distrust what is being rebuilt, but because decentralized science is healthier than science that flows only from the top. The work our team published is exactly the kind of research that should exist alongside what government agencies produce: a check, a comparison, an independent voice.

The study is published. The methodology is transparent. Anyone can examine it.

  • Natalya Murakhver is co-founder of Restore Childhood, a nonprofit dedicated to ending COVID mandates for children and restoring athletics, art and academics across the United States. She is producing “15 Days . . . ,” a documentary on the lockdowns.

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