BREAKING: FDA Refuses to Add “Black Box Warning” to mRNA Injections—Despite FDA Scientists Recommending It
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A few days ago, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death.
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However, in a striking reversal first reported by Maryanne Demasi, FDA Commissioner Dr. Marty Makary appeared on Bloomberg and claimed the agency now has “no plans” to implement a black box warning—despite the FDA’s own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and “leadership” thought it would be a bad idea.
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Dr. Makary stated:
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Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine. The Safety and Epidemiology center within the FDA did recommend that it was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.
Because when you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people. Now that it’s annual, you may not see that same prevalence.
So we don’t want to extrapolate findings to today if it’s not transferable.
This rationale is deeply flawed—and gravely worrisome. It assumes that cardiotoxic injury from mRNA injections is acute, transient, and dose-interval dependent, rather than structural, cumulative, and capable of causing delayed fatal outcomes. That assumption is directly contradicted by the peer-reviewed literature.
Six of our peer-reviewed studies demonstrate unequivocally that COVID-19 mRNA injections are profoundly cardiotoxic, producing irreversible myocardial injury and scarring capable of triggering fatal arrhythmias and Sudden Adult Death Syndrome months to years after exposure:
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1. Hulscher N, Hodkinson R, Makis W, McCullough PA. Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis. ESC Heart Failure. 2024 Jan 14. doi: 10.1002/ehf2.14680 (https://pubmed.ncbi.nlm.nih.gov/38221509/)
2. McCullough PA, Hulscher N. Risk stratification for future cardiac arrest after COVID-19 vaccination. World J Cardiol. 2025;17(2):103909. doi:10.4330/wjc.v17.i2.103909 (https://pubmed.ncbi.nlm.nih.gov/40061285/)
3. Rose J, Hulscher N, McCullough PA. Determinants of COVID-19 vaccine-induced myocarditis. Therapeutic Advances in Drug Safety. 2024;15. doi: 10.1177/20420986241226566 (https://pmc.ncbi.nlm.nih.gov/articles/PMC10823859/)
4. Hulscher N, Cook MJ, Stricker RB, McCullough PA. (2024). Excess Cardiopulmonary Arrest and Mortality after COVID-19 Vaccination in King County, Washington. J Emerg Med OA, 2(1), 01-11. doi: 10.33140/JEMOA.02.01.12 (https://opastpublishers.com/open-access-articles/excess-cardiopulmonary-arrest-and-mortality-after-covid19-vaccination-in-king-county-washington.pdf)
5. Mead MN, Rose J, Makis W, Milhoan K, Hulscher N, McCullough PA. Myocarditis after SARS-CoV-2 infection and COVID-19 vaccination: Epidemiology, outcomes, and new perspectives. Int J Cardiovasc Res Innov. 2025; 3(1); 1-43. doi: 10.61577/ijcri.2025.100001 (https://reseaprojournals.com/journals/cardiovascular-research/Articles/myocarditis-after-sars-cov-2-infection-and-covid-19-vaccination-epidemiology-outcomes-and-new-perspectives)
6. McCullough PA, Mead N, Hulscher N. COVID-19 Vaccine-Induced Subclinical Myopericarditis: Pathophysiology, Diagnosis, and Clinical Management. Medical Research Archives. 2025;13(11). doi:10.18103/mra.v13i11.7078 (https://esmed.org/MRA/mra/article/view/7078)
These findings do not depend on whether injections are given quarterly or annually. Myocardial scarring does not reverse simply because the dosing schedule changes. Once present, it remains a lifelong arrhythmogenic substrate.
Just as it appeared that regulatory accountability might finally emerge, the Bio-Pharmaceutical Complex once again demonstrated its capacity to shield it’s holy grail: the deadly mRNA gene-transfer platform.
When an FDA safety center formally recommends a black box warning—and leadership overrides it despite mounting evidence of irreversible cardiac injury—the issue is no longer scientific uncertainty. It is institutional capture.
The mRNA shots should have been removed from the market in 2021 due to mass casualties—and here we are in 2025 still fighting for a mere black box warning.
Thankfully, courageous policymakers from across the country are not backing down: see this.
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Nicolas Hulscher, MPH, Epidemiologist and Foundation Administrator, McCullough Foundation
Featured image is from Children’s Health Defense
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