3 Peer-Reviewed Studies Provide Irrefutable Grounds for Immediate Market Withdrawal of COVID-19 mRNA Injections

International evidence converges: mRNA shots are unsafe, ineffective, contaminated, and in violation of international law.

This article originally appeared on Focal Points and was republished with permission.

Guest post by Nicolas Hulscher, MPH

Two major peer-reviewed papers were published in the last 48 hours — one from Japan and another from an international team of physicians and researchers, including those from the McCullough Foundation.

These build directly on our foundational peer-reviewed paper published earlier this year, which comprehensively established the case for terminating mRNA injection programs.

Together, these three studies converge on the same conclusion:

The modified COVID-19 mRNA injections are unsafe, ineffective, contaminated, and in violation of international law.

This is now the strongest scientific and ethical case yet for immediate global withdrawal of mRNA-LNP products.

COVID-19 Injections: Harms and Damages, a Non-Exhaustive Conclusion

Andrew Zywiec, Irene Mavrakakis, Peter McCullough, Nicolas Hulscher, Aaron Kheriaty, Paul Marik, James Thorp, Marivic Villa, Charles Rixey, Lt. Edward Macie, Abraxas Hudson.
Journal of American Physicians and Surgeons. August 2025

Key Findings:

• Genomic forensics: SARS-CoV-2 and mRNA injections display signatures of laboratory manipulation — furin cleavage site, HIV-like inserts, SEB superantigen motifs, ENaC epitope, DC-SIGN receptors.

• These features match DARPA’s 2018 DEFUSE proposal. Fauci and Farrar’s Feb. 1, 2020 teleconference sought to suppress discussion of these engineered elements, coordinating the “proximal origin” cover-up.

• NATO scientists rated SARS-CoV-2 the 4th most attractive bioweapon candidate out of 34 agents.

• Both the virus and the mRNA injections represent violations of the Biological Weapons Convention (BWC).

Documented Harms:

• Cardiovascular: +510% myocarditis risk (99M cohort); +286% heart attacks, +240% strokes, +199% arrhythmias (85M cohort).

• Autopsies (325 cases): High likelihood of direct causal link between vaccination and death.

• Life expectancy loss: Two-dose recipients lost 37% of expected lifespan in follow-up studies.

• Reproductive: Pfizer’s 2021 report showed 81% miscarriage rate in early pregnancies; NEJM reanalysis confirmed 82% loss rate, comparable to abortion drugs. Stillbirths and neonatal deaths were several-fold higher than baseline.

• Immune collapse: >90% of vaccine-injured retirees showed latent virus reactivation (EBV, CMV, HHV-6, HSV, Borrelia); ~75% had autoimmune markers.

• Cancer: Surge in aggressive tumors (digestive, brain, breast) linked to IgG4 tolerance, p53 disruption, DNA contamination, and mistranslation from modified nucleosides.

• Military readiness: Defense Medical Epidemiology Database (DMED) showed:

  • +153% myocarditis (2023),

  • +46% digestive cancers,

  • +262% obesity,

  • +867% slip/trip/fall injuries,

  • +85% suicidal/homicidal ideation.

• Nearly 95,000 service members separated under mandates, undermining readiness.

Conclusion From Paper

The COVID-19 pandemic response violated core principles of public health, medical freedom, and bodily autonomy, amplifying the devastating effects of SARS-CoV-2 and its modified mRNA biologics/vaccines. The overwhelming evidence of SARS-CoV-2’s gain-of-function origins, coupled with the catastrophic health impacts of modified mRNA COVID-19 biologics/vaccines and the unchecked expansion of next-generation mRNA biologics, paints a chilling picture of deliberate design and systemic harm. Engineered viral features and vaccines that devastate immunological, cardiovascular, reproductive, and neurological systems have driven staggering morbidity and mortality, with effects unlikely to be accidental. Coordinated efforts to obscure these truths, enabled by liability shields and legislative failures, have worsened a global health disaster. The surge in autoimmune diseases, aggressive cancers, pregnancy losses, cardiovascular fatalities, societal fragmentation, and the looming risks of advanced mRNA platforms demand an immediate halt to mRNA vaccine and biologic use, comprehensive investigations into the motives behind this unprecedented violation of public trust, and robust measures to restore safe therapeutics and ethical public health practices. Humanity deserves accountability, transparency, and a resolute commitment to preventing such engineered calamities in the future.

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Regulatory and Safety Assessment of COVID-19 mRNA-LNP Genetic Vaccines in Japan: Evidence for Revocation of Approval and Market Withdrawal

Jun Ueda, Miki Gibo, Takayuki Kikuchi, Yuriko Hirai, Mariko Miyokawa, Isamu Shima, Shinichiro Kodama, Masanori Fukushima.
Science, Public Health Policy, and the Law. August 2025

Key Findings:

• Mass Administration Without Oversight

  • Japan injected 103.46 million people (79.5% of the population) with mRNA-LNP vaccines, yet never conducted a nationwide safety investigation.

• Misclassification as Vaccines

  • The PMDA reviewed mRNA shots under vaccine guidelines, instead of the stricter standards for gene therapy. This allowed approval despite their fundamentally different mechanism of action.

• Critical Safety Studies Skipped

  • No evaluation of biodistribution, organ-specific toxicity, carcinogenicity, genotoxicity, placental transfer, fetal toxicity, or long-term safety was conducted.

• Omicron XBB.1.5 Authorized Without Clinical Trials

  • The updated product was approved solely on non-clinical antibody data — no human trials were performed.

• Adverse Events Concealed

  • Known risks — myocarditis, thrombosis, autoimmune disease, pregnancy complications — were excluded from package inserts, violating physicians’ duty to warn.

• Suppression of Mortality Data

  • MHLW documents showed higher case fatality rates among the vaccinated, but the government suppressed this data and instead promoted the false claim that shots prevented severe disease.

• DNA Contamination

  • Independent labs detected plasmid DNA fragments, including SV40 promoter sequences, in Pfizer/Moderna vials. These contaminants were not disclosed during regulatory review and pose risks of genomic integration and oncogenesis.

• saRNA Platforms

  • Japan is already advancing self-amplifying mRNA (saRNA) injections like ARCT-154/Kostaive, despite early evidence of lab abnormalities, systemic persistence, and fetal transfer in animal studies.

  • Authors warn this could repeat the same catastrophic errors, only on a larger scale.

• Legal and Ethical Breaches

  • Failures by the PMDA and MHLW constitute violations of the PMD Act, the duty to warn, and constitutional rights to health and self-determination.

Conclusion From Paper

The risks and adverse events associated with SARS-CoV-2 genetic vaccines far exceed initially anticipated efficacy and adverse drug reactions, warranting immediate market withdrawal. Latest analyses based on real-world data demonstrate serious safety concerns regarding genetic vaccines (notable excess mortality, decreased efficacy and negative effects, increased autoimmune disease risk, DNA contamination and potential carcinogenic risk, risks substantially exceeding FDA recall criteria) [166, 167], making reassessment of vaccination policy and implementation of independent investigations essential. Based on the accumulated evidence to date, the continued administration of SARS-CoV-2 genetic vaccines poses significant public health concerns. Therefore, the revocation of their regulatory approval and immediate market withdrawal should be seriously considered by relevant authorities.

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Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits

Nicolas Hulscher, Mary T. Bowden, Peter A. McCullough
Science, Public Health Policy, and the Law. January 2025

BREAKING - Peer-Reviewed Manuscript Finds Irrefutable Evidence Supporting Immediate Market Withdrawal of COVID-19 "Vaccines"

Key Findings:

• More than 81,000 physicians/scientists/citizens, 240 government officials, 17 professional physician and scientific organizations, and 2 U.S. state parties have formally called for withdrawal.

• VAERS reports: 19,028 U.S. deaths attributed to vaccines. Adjusting for underreporting, true deaths may exceed 589,000 in the U.S. alone.

• Global estimates: up to 17 million deaths worldwide.

• Studies consistently show higher excess mortality where vaccination rates are highest (U.S., Europe, Australia).

• Negative efficacy: Multiple studies demonstrate vaccinated individuals are at higher risk of infection than unvaccinated, particularly after boosters.

• DNA contamination: 11 reports have found DNA contamination in COVID-19 vaccines, documented across multiple manufacturers, vaccine platforms, and geographic regions, with levels far exceeding regulatory thresholds by up to 65,500%.

• Recall thresholds exceeded: Past vaccines were pulled after 10–53 deaths (Cutter polio, Swine flu, Rotashield). COVID-19 shots have been linked to tens of thousands more deaths in VAERS — up to 375,340% beyond FDA Class I recall criteria.

Conclusion From Paper

We expect that calls for an immediate moratorium on COVID-19 vaccines will continue to increase until a critical mass is reached, and the products are finally removed from the market. Excess mortality, negative efficacy, and widespread DNA contamination associated with COVID-19 vaccines have been sufficiently demonstrated. The FDA's criteria for a Class I recall have been far exceeded. No large-scale, conclusive, randomized, double-blind, placebo-controlled trials have demonstrated reduction in infection transmission, hospitalization, or death as primary endpoints. Thus, the COVID-19 vaccines are not proven to be effective in reducing important clinical outcomes. A position supporting COVID-19 vaccination goes against good medical practice and violates the Hippocratic Oath to above all, do no harm. Immediate removal of COVID-19 vaccines from the market is essential to prevent further loss of life and ensure the next steps for accountability are taken.

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Two new peer-reviewed papers in the past 48 hours, plus one foundational review earlier this year, now align:

• The shots are unsafe, ineffective, contaminated, and unlawful.

• Regulators skipped critical safety tests, concealed harms, and approved products unfit for human use.

• The scientific, ethical, and legal case for immediate global withdrawal is overwhelming.

They call for:

• All genetic COVID-19 products must be immediately removed from the market.

• Self-amplifying mRNA platforms must be stopped before repeating this disaster.

• International investigation under the Bioweapons Convention is indicated.

As the regulatory agencies across the world continue to authorize and distribute COVID-19 mRNA injections, they will continue causing severe injury and death among their own populations.

Now is the time to stand on the right side of history — or be remembered by future generations as complicit in one of the greatest tragedies of our time.

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The McCullough Foundation will continue to fight for truth, accountability, and restoration of public health — and we ask for your support as we press forward in this historic battle: mcculloughfnd.org/products/donate-1

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1. Zywiec A, Mavrakakis I, McCullough P, Hulscher N, Kheriaty A, Marik P, Thorp J, Villa M, Rixey C, Macie E, Hudson A. COVID-19 Injections: Harms and Damages, a Non-Exhaustive Conclusion. J Am Phys Surg. 2025;30(3):80-94

2. Ueda J, Gibo M, Kikuchi T, Hirai Y, Miyokawa M, Shima I et al. Regulatory and Safety Assessment of COVID-19 mRNA-LNP Genetic Vaccines in Japan: Evidence for Revocation of Approval and Market Withdrawal. Science, Public Health Policy and the Law. 2025 Aug 26; v8.2019-2025

3. Hulscher N, Bowden M T., McCullough P A.. Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits. Science, Public Health Policy and the Law. 2025 Jan 28; v6.2019-2025

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Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

Support our mission: mcculloughfnd.org

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Copyright 2025 Focal Points

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