Reckoning of Regulatory Failures

Reckoning of Regulatory Failures- 2

Admissions from the world’s leading regulatory bodies has ripped the veil from the mRNA COVID-19 vaccine approvals, revealing a process marred by corruption, conflicts of interest, and outright systemic deception. What was sold as a triumph of science – Pfizer’s Comirnaty and Moderna’s Spikevax – was produced and approved through a process riddled with shortcuts and outrigt deception, yet was greenlit with regulatory agencies deferred to manufacturer’s self-reported data without independent verification or any comprehensive long-term safety data and ignored warnings signals, leaving billions exposed to experimental gene therapies. This regulatory fiasco, a collapse in oversight driven by emergency pretexts, pharma lobbying and political expediency has fueled excess deaths, genomic risks, and eroded trust. Yet the scam product is still recommended world wide.

Purity scandals

Studies have repeatedly confirmed residual plasmid DNA contamination in commercial mRNA vaccines (Pfizer-BioNTech and Moderna), often exceeding regulatory limits (FDA/WHO: ≤10 ng/dose, fragments <200 bp). These findings highlight manufacturing inconsistencies, with DNA encapsulated in lipid nanoparticles, raising risks of genomic integration and oncogenesis.

A 2025 study from the University of Guelph, published in September, analyzed vials from Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines, finding total DNA contamination exceeding FDA limits by 36-153-fold in Pfizer vials and112–627-fold in Moderna vials (surpassing WHO limits by up to 62,700%), including the oncogenic SV40 promoter-enhancer-ori sequence (0.25–23.72 ng/dose) – a tumour-triggering nuclear driver undisclosed during 2020 approvals, risking genomic integration. Hundreds of millions to hundreds of billions of DNA fragments, far exceeding allowed regulatory limits, encased in lipid nanoparticles specifically designed to breach cells, were found in the vials of COVID-19 mRNA vaccines for commercial use on people, while the companies used cleaner batches in their clinical trials. Cumulative dosing amplifies oncogenic potential, autoimmunity, and insertional mutagenesis – unquantified threats and untested cumulative risks of the products that went out on the market.

A 2025 Microorganisms study by König et Kirchner analyzed four vials of experimental mRNA vaccines, finding two exceeded DNA limits by up to 534-fold via orthogonal methods (qPCR, fluorometry), with fragments up to 3.5 kb encapsulated in LNPs for cellular uptake. The authors write: “The manufacturer of the mRNA vaccine Comirnaty (BioNTech/Pfizer) only measures DNA impurities in the active substance by means of a quantitative polymerase chain reaction (qPCR), whose DNA target sequence is less than just 1% of the originally added DNA template.” and “very high DNA values were measurable in all batches /–/ with these values ranging from 360 to 534 times the permissible DNA limit or 3600 to 5340 ng DNA per dose.”

This echoes a 2023 OSF preprint by Speicher et al. sequencing Pfizer monovalent/bivalent vials, detecting significant plasmid DNA fragments (mean 214 bp) from E. coli origins, including SV40 promoter, at levels implying 10^8–10^11 copies/dose. It says: “The SV40 promoter-enhancer-ori was only detected in Pfizer vials with Cq scores ranging from 16.64 – 22.59. In an exploratory analysis, we found preliminary evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). This relationship was different for the Pfizer and Moderna products. Size distribution analysis found mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively. The plasmid DNA is likely inside the LNPs and is protected from nucleases. Conclusion: These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry, all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”

Speicher, D. J., et al. (2025 PubMed) analyzed 32 vials (16 lots) of Pfizer/Moderna, finding total DNA 371–6,280 ng/dose (36–627-fold over limits), including SV40 promoter-enhancer-ori at 0.25–23.72 ng/dose in Pfizer (2-fold exceedance in 3 lots). Fragments up to 3.5 kb via Nanopore sequencing.

McKernan, K. (2023 OSG Preprint) sequenced monovalent/bivalent Pfizer/Moderna vials, detecting E. coli plasmid DNA fragments (mean 214 bp) at 10^8–10^11 copies/dose, including SV40 promoter, exceeding limits and risking integration.

Raoult, D. (2024 HAL) confirmed plasmid DNA presence in Pfizer vials via qPCR, with levels >10 ng/dose and SV40 sequences, suggesting incomplete purification and potential oncogenic risks.

Buckhaults, P. (2023 SC Senate PDF) analyzed Pfizer vials, detecting plasmid DNA contamination, leftover from production, at >10 ng/dose, including bacterial sequences, absent from trials and risking inflammation/integration.

No regulatory agency found this because they trusted the fraudulent data given by the pharmaceutical companies, who used cleaner batches in their clinical trials. This isn’t oversight; it’s a manufacturing catastrophe.

The EU’s Confession: Vaccines Rolled Out as Human Experiments

EMA’s conditional approvals (December 2020) skipped full Phase III, relying on interim data from 44,000 participants—insufficient for events like myocarditis (later 1-in-2,600 in boys) as well as Ursula von der Leyen’s 2022 SMS scandal with Pfizer CEO Albert Bourla (DW) involving undisclosed and deleted texts where they negotiated €1.8 billion doses of COVID-19 vaccines, and the Commission’s evasion about not re-calling the mRNA injections despite the huge amount of side effects reported – claiming “ongoing monitoring” via EudraVigilane enough – again highlights capture.

In a response to a demand from Austrian MEP Gerald Hauser’s (Freedom Party of Austria, FPÖ, E-003388/2025), probing why mRNA vaccines remained recommended for pregnant women, infants, and healthy individuals despite the incomplete safety studies the European Union’s Commission made a huge confession. The Commission’s reply confirmed that conditional marketing authorizations for vaccines like Comirnaty and Spikevax were granted on behalf of all EU countries without complete long-term safety or efficacy data, relying on “interim analyses” and manufacturer submissions. The damning clause in the EU Comission Advance Purchase Agreement (APA) with BioNTech-Pfizer in 2020, unredacted APA in Italy’s April 2021 parliamentary release but heavily censored in the official EU version states (page 48-49): “The Participating Member State further acknowledges that the long-term effects and efficacy of the Vaccine are not currently known and there may be adverse effects of the Vaccine that are not currently known.” Mirrored in Moderna and AstraZeneca contracts, this indemnity clause treated EU citizens as de facto test subjects, with member states waiving rights to full data.

ACIP’s Pivot: U.S. Lack of Oversight Exposed

The U.S. reckoning began unfolding at ACIP’s September 18-19, 2025, meeting, with the new advisory panel – all without any personal financial ties to a pharmaceutical company unlike earlier ACIP members. ACIP unanimously ended routine mRNA vaccine injections recommendations for all ≥6 months, instead advising a “shared clinical decision-making” amid today’s 90% non-uptake of the mRNA vaccines among the American public.

Workgroup lead Retsef Levi (MIT) decried low-quality efficacy data of the updated mRNA COVID-19 vaccines; Pfizer/Moderna formulations targeting KP.2 strain. The most favorable group data had a mere 44-46% Vaccine Efficacy (VE) in immunocompromised ≥65 year olds vs. hospitalization, dropping to 30-40% in healthy ≥65 and less than 20% in younger adults and > 10% in children. It is far below the original trials’ 95% claims. VE measures RRR, a relative reduction in disease risk post-approval between vaccinated vs unvaccinated, unlike trial-based efficacy. RRR always overstates benefits. ARR, the Absolute risk reduction, is however based on the actual number of hospitalizations prevented per population and that number was ~369 hospitalizations prevented per 100,000 vaccinated immunocompromised adults aged 65+, even less in healthy vaccinated over 65, down to an absolute risk reduction of ~1-2 averted hospitalizations per 10,000 vaccinated child. This highlights the extremely limited real-world impact the mRNA injections had. Any effect waned rapidly after 3 months, 2 months in children. The endpoint was to prevent severe outcomes (hospital admission for COVID), not infection or transmission, but no strong data for milder endpoints or long COVID prevention exists.

There also were no RCT, randomised controlled trials (gold standard), proving any all-cause mortality benefits, i.e. could show mRNA vaccines reduced deaths from any cause (e.g., heart disease, cancer). Original trials (e.g., Pfizer NCT04368728, n=44,000) were powered for COVID-specific endpoints, with 0-2 all-cause deaths per arm – insufficient for mortality analysis. Observational studies (e.g., 2023 Lancet meta, n=1M+) show no overall mortality benefit, with signals of non-COVID increases (e.g., cardiac, 1.2-1.5 HR post-vax). Again, this underscores mRNA’s narrow, waning benefits only in vulnerable subgroups, without broader mortality benefit proof.

No pregnant animal tests preceded rollout, despite Pfizer’s NCT04754594 clinical trial showing 8 congenital anomalies in 156 vaccinated vs. 2 in 159 unvaccinated (~5% vs. 1.3% rate, exceeding 3-4% baseline). ACIP decided to oppose routine pregnancy shots.

The purity scandal, with plasmid DNA and SV40 sequences exceeding regulatory limits, were discussed at the ACIP meeting as well. The meeting referred to, aside from studies mentioned earlier in this article, research confirming contamination and highlighting the purification failure and the divergence from trial documentation like Kaiser, S., et al., Kämmerer, U., et al. (2024), König, B. (2024) and Wang, W., et al. (2024).

Prof. Charlotte Kuperwasser (Tufts) and Prof. Wafik El-Deiry (Brown) labeled the Moderna’s biodistribution fraud “baffling – if not criminal”: their clinical studies used surrogate mRNA and not what was used in the commercial product.

The manufacturing inconsistencies – commercial batches dirtier than trials – raise oncogenic and autoimmune risks from billions of fragments/dose. These issues were flagged as four core risks:

(1) IgG4 class-switch, inducing immune tolerance post-boosters;
(2) spike protein persistence up to 709 days in tissues;
(3) frameshifting from pseudouridine, yielding up to 10x rogue proteins
(4) subclinical myocarditis, with 2-3% troponin elevation and a 1-in-2,600 risk for boys aged 12-17. The UK JCVI modeling further underscore futility of routine use: Vaccinating 113,700 healthy low-risk teens (15-19) averts just one hospitalization but causes 44 myocarditis cases.

Post-vaccine syndrome (PVS), a severe vaccine side effect, was acknowledged for the first time.

Votes reflected the gravity of the situation: With An 11-1 decision ACIP updated Vaccine Information Statements (VIS) with warnings on low-quality data, immune changes, myocarditis deaths, PVS, spike persistence, and pregnancy gaps.

Retraction Demands

These regulatory failures—agencies blindly accepting unverified manufacturer claims as actual safety data, without independent confirmation of the gene-altering mRNA products’ safety—allowed catastrophic oversights. Post-marketing, they failed to spot contaminated products and deliberately ignored independent research alarms on plasmid DNA and SV40 contamination, even as it far exceeded FDA/WHO limits. Safety surveillance systems like VAERS, capturing <1% of severe adverse events including deaths (per Harvard Pilgrim 2010 analysis), generated ignored red flags. Driven by pharma pressure and glaring financial conflicts (e.g. FDA’s 47% user fees plus personal financial ties), regulators expedited approvals sans full Phase III trials, rubber-stamping a failed drug for global mandates – and keep on recommending it. The health ramifications of prolonged, persistent spike protein production—inducing chronic inflammation, autoimmunity, cancer and genomic instability—remain utterly unstudied. Yet the inaction festers, enabling ongoing harm and perpetuating a betrayal of the public.

Regulatory agencies worldwide have historically withdrawn vaccines or drugs after relatively few reported deaths or serious adverse events, often 1-50 cases, to protect public health. This conservative approach prioritizes caution, as passive systems like VAERS capture only ~1% of events. Some examples are:

Rotashield (rotavirus vaccine, 1999) was withdrawn after 15 intussusception cases and 1 death in ~1 million doses. Here FDA acted on early signals.
Swine flu vaccine (1976) was halted after 25 Guillain-Barré syndrome cases and 1 death in 45 million doses. CDC paused due to the risk-benefit imbalance.
Vioxx (rofecoxib, 2004) was withdrawn after ~27,000 heart attacks/strokes (thousands deaths) in post-market data. FDA threshold ~50 serious signals.
Dengvaxia (dengue vaccine, 2017) was paused in Philippines after 8 deaths in seronegative children; WHO recommended restrictions globally.
The Cutter Incident in 1955, when a polio vaccine caused 200 paralyzed and 10 deaths from contaminated lots, led to immediate recall and stricter manufacturing rules.

Of 462 products withdrawn 1953-2013, 38% occurred within 1 year of first death reports, often for hepatotoxicity or cardiac risks (median 2-10 deaths).

In contrast, mRNA COVID vaccines remain on the market despite ~36,000 U.S. VAERS death reports (as of September 2025, extrapolated to 3.6 million deaths if at 1% capture) and ~50,000 EudraVigilance fatalities (January 2021-September 2025, ~12,000 in 2023 alone; extrapolated to 5 million potential deaths if also at 1% capture).

The regulatory collapse, driven by pharma influence, have left billions exposed to untested gene therapies. Many doctors, scientists and witnesses demand a suspension of the failed mRNA technology and are still ignored. Meanwhile so-called medical “experts”, media and politicians – all funded by the manufacturers – still proclaim people need to let themselves be injected yet again, preparing for new mRNA vaccine mandates. They are unable to back away. Why?

Because a retraction demands accountability.

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