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The Office of Gene Technology Regulator is questioned about gene therapies and the mRNA vaccines. The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's non-clinical report to argue that mRNA vaccines are gene therapy. The regulator deflects responsibility for testing genotoxicity and claims that the Gene Technology Act does not apply to manufacturing in other countries. The speaker disagrees, citing Pfizer's acknowledgment of transfection as part of gene therapy. The regulator disputes the definition of gene therapy. The conversation ends without resolution.

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Health authorities and the media have been accused of misleading the public about the safety of COVID injections, with evidence suggesting they concealed adverse event data. Recent emails from Australia’s Therapeutic Goods Administration (TGA) reveal that officials acknowledged the potential for DNA fragments from mRNA vaccines to integrate into human genomes, contradicting their public statements. Despite this, the TGA focused on dispelling public fears rather than investigating risks. Concerns have been raised about the lack of testing for DNA integration and the overall safety of the vaccines. Senator Gerard Renick criticized the TGA for its poor quality assurance and lack of accountability, highlighting the need for greater scrutiny of vaccine safety and the political failures that allowed these issues to persist. The situation reflects broader frustrations with government transparency and public health decisions in Australia.

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The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's report to argue that mRNA vaccines are a form of gene therapy. They question why the mRNA vaccine was not tested for genotoxicity and why the Office of Gene Technology Regulator did not consider it as gene technology. The regulator responds that the question of genotoxicity should be directed to the Therapeutic Goods Administration, and explains that since the mRNA vaccines were imported into Australia and not manufactured there, they are not responsible for checking gene therapy. The speaker disagrees, citing Pfizer's statement about transfection being a part of gene therapy. The regulator suggests a difference in the definition of gene therapy.

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- The m n r m r n a technology was a radical qualitative leap forward in technology. - The mRNA is a type of vaccine. - The reason it was called a scene was because was a brand name that had a track record of safety, and shoehorning it in that was one of the ways to make sure that people weren't terrified of the technology. - It bears very little resemblance to anything that went before that. - There are different types that they didn't have to contend with the fact that it wasn't the same technology. There are different technologies. - There certainly are. That are different technologies.

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The Office of Gene Technology Regulator is questioned about gene therapies and the mRNA vaccines. The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's non-clinical report to support the claim that mRNA vaccines are gene therapy. The regulator deflects responsibility for testing genotoxicity and manufacturing processes conducted in other countries. The speaker highlights the contradiction in the regulator's statements and the disagreement with Pfizer's definition of gene therapy. The regulator argues that the definition of gene therapy is subjective. The conversation ends without a resolution.

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The Pfizer and Moderna vaccines contain fragments of DNA, which can integrate into the genomic DNA of cells and become a permanent part of the cell. This poses a potential risk of autoimmune attacks and future cancer. The DNA contamination occurred during the production process, where a plasmid vector was used to scale up the production of the RNA template. The regulatory threshold for DNA in vaccines is outdated and not suitable for this new type of vaccine. The speaker believes that DNA sequencing should be done on vaccinated individuals' stem cells to determine if this theoretical risk has occurred. Informed consent is necessary, and the lack of transparency regarding the DNA contamination is concerning.

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Before the emergency use authorization of the vaccines, significant concerns were already known. The Pfizer technical document revealed that these vaccines caused widespread distribution of the encoded protein in major tissues and were associated with inflammatory reactions due to lipid nanoparticles. It was understood that these nanoparticles could deliver RNA and DNA into cells, and the use of pseudo uridine was intended to enhance the immune response and prolong the product's effectiveness. However, critical investigations regarding potential shedding, reproductive toxicity, and the presence of contaminants were not conducted. These omissions are concerning, especially considering previous FDA regulations that recognized the risks of genotoxicity related to manufacturing processes.

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The speaker questions whether the mRNA complexes in the vaccines meet the definition of genetically modified organisms (GMOs) under Australian legislation. The response states that mRNA technology is not gene therapy and does not alter human DNA. The speaker insists on knowing if the possibility was examined, but the response reiterates that the vaccines are not GMOs. The speaker then asks if Pfizer has notified its underwriters about potential litigation, but the response is uncertain and requests further investigation. Another speaker presents a document from Pfizer's website stating that gene technology includes a process used in the COVID vaccine. The committee agrees to review the document and suggests sending additional questions to Pfizer.

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Many labs, including Medicinal Genomics, found DNA contamination in Pfizer and Moderna mRNA vaccines. Regulators like the FDA and EMA admitted to this, but downplayed its significance. The SP 40 sequences omitted by Pfizer are crucial. DNA contamination can cause insertional mutagenesis, as stated in Moderna's patents. Regulatory agencies were deceived and failed to properly address the issue. This poses a serious risk that cannot be ignored.

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The Office of Gene Technology Regulator is questioned about gene therapies and the mRNA vaccines. The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's non-clinical report to argue that mRNA vaccines are gene therapy. The regulator deflects responsibility for testing genotoxicity and claims that since the mRNA vaccines were imported into Australia, they were not manufactured there. The speaker disagrees, stating that transfection still occurs in Australian citizens. The regulator disagrees with the definition of gene therapy and the reliance on the manufacturer's statements. The conversation ends without a resolution.

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Pfizer's own document, the American Society of Gene and Cell Therapy, and the TGA all acknowledge that mRNA vaccines are a form of gene therapy. The speaker questions why the mRNA vaccine wasn't tested for genotoxicity and why the Office of Genetic Therapeutics didn't consider it as gene technology. The response states that the TGA is responsible for approving the vaccine and the question of genotoxicity should be directed to them. It is clarified that the mRNA vaccines were imported into Australia and not manufactured there. The speaker disagrees, citing Pfizer's admission that transfection is part of gene therapy. The response disagrees with the speaker's interpretation.

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Pfizer's own website acknowledges that gene therapies involve a complex process, including transfection. The American Society of Gene and Cell Therapy defines the COVID mRNA vaccine as a gene therapy that introduces new genetic material temporarily. The TGA's non-clinical report confirms the use of DNA in Pfizer's manufacturing process. The senator questions why the mRNA vaccine wasn't tested for genotoxicity and why the Office of Gene Technology didn't review it as a gene technology. The Gene Technology Regulator states that the TGA is responsible for approving vaccine products and addressing genotoxicity concerns. They clarify that the mRNA vaccines were imported into Australia, and if manufacturing and gene technology were involved, approval would have been required. The Regulator disagrees with the claim that transfection occurs in Australian citizens. The Office of Gene Technology's role is limited to assessing containment and environmental risks.

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The Office of Gene Technology Regulator is questioned about gene therapies and the mRNA vaccines. The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's non-clinical report to support the claim that mRNA vaccines are gene therapy. The regulator deflects responsibility for testing genotoxicity and manufacturing processes conducted in other countries. The speaker highlights the contradiction in the regulator's statements and emphasizes that transfection, a part of gene therapy, occurs in Australian citizens. The regulator disagrees and questions the definition of gene therapy. The speaker concludes by relying on the manufacturer's statements.

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Speaker 0: I find information like this, you know, inserts for the vaccine. Paper's there, and there's nothing printed on it. I find that very interesting, disheartening, disgusting, and lots of other words, but then it gets better. It just keep wait. There's more. It just keeps happening. The CDC redacts every single word of a 148 page study on a myocarditis after COVID vaccination. So I asked research to print the study for me. 148 pages. The entire thing is redacted. What good does a study do if there's nothing there? Then I wanna know, wait, what might have been there that they needed to redact it? That's even scarier. Speaker 1: We're witnessing an active cover up of a colossal consumer product safety debacle that is is basically affecting the entire world. Mhmm. So in The United States, our CDC, National Institutes of Health, and the FDA are actively involved in a cover up. And the same is occurring in The UK with the MHRA, Europe with European medicine agencies, and Australia with the Therapeutic Goods Administration. Something is going on that's very big. Each one of these companies that puts out a product has an obligation to produce ninety days of safety monitoring after their product comes out. It's a regulatory dossier. If somebody has a problem with the new product and they call the company like Pfizer, Pfizer has to report, write down what happened, and they have to collate that in a report and produce it and make it publicly available. When it came to ninety days with Pfizer, the first vaccine that came out, remember Pfizer was approved 12/10/2020. Pfizer didn't produce the report. And then people started asking, well, what's happening with your vaccine? And Pfizer would not disclose what happened. And then it went to court. And the lawyer for the FDA stepped in and said they don't wanna release Pfizer's dossier for fifty five years. Mhmm. Oh. Fifty five years. And the the the plaintiff pushed. And finally, slowly, the Pfizer dossier came out. Pfizer recorded one thousand two hundred and twenty three deaths with their product within ninety days of release. People were calling Pfizer in desperation watching their family members die after taking the vaccine. Pfizer recorded over twelve hundred new adverse events, new problems that doctor Boden has talked to you about that we are grappling with the entire time. But the point is our FDA worked to cover this up. The FDA should be regulating this company. FDA should have been having at least monthly meetings and fully disclosing what was going on with these novel vaccines, which are a genetic transfer technology platform.

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Every childhood vaccine will be mRNA, becoming gene therapies that alter genetics without re-approval. COVID vaccines were profitable data and experimentation tools, but the danger lies in continued genetic tinkering. mRNA is being integrated into every vaccine. Therefore, no vaccines should be taken. All vaccines are being redesigned to include gene therapies because there is so much money in it.

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I've been involved in over 50 vaccines, including mRNA vaccines. mRNA is like DNA, giving cells instructions to make proteins. This technology was originally for gene therapy, now used for vaccines. It's a new, experimental technology never used in humans before COVID. Animal studies were skipped for COVID vaccines, a novel approach.

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FDA has not performed independent inspection of mRNA shots for DNA contamination, instead relying on Pfizer and Moderna's data. "The FDA acknowledged relying solely on manufacturer submitted data for compliance without independent postproduction verification" and "stated it is discussing the issue seriously, though no timeline for action was provided." Studies since 2023, including Kevin McKernan and David Spiker, "confirmed excess plasmid DNA fragments, including s v 40 sequences in vaccine vials from multiple countries" while the FDA "maintains no evidence of harm from over 13,000,000,000 global doses." "Despite independent studies detecting DNA contamination levels up to hundreds of times above the ten nanograms per dose regulatory limit." "No independent verification of manufacturers' claims. It's like having a fox guarding the henhouse." "alarm bells, genetic fingerprint of COVID vaccine found in 31 year old cancer patients' DNA." "We have identified the first instance, first direct molecular evidence of genomic integration of mRNA vaccine genetic material" with "20 base pair" "perfect match" "chromosome 19" "non safe harbor region." "This was accompanied by severe, severe genetic dysfunction" and "it should demand the immediate withdrawal of these mRNA products." "Has anyone inside the administration begun a formal investigation... moratorium on these injections?"

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The speaker presents evidence from Pfizer's website, the American Society of Gene and Cell Therapy, and the TGA's report to argue that mRNA vaccines are a form of gene therapy. They question why the mRNA vaccine was not tested for genotoxicity and why the Office of Gene Technology Regulator did not consider it as gene technology. The regulator responds that the TGA is responsible for approving vaccine products and addressing genotoxicity concerns. They explain that since the mRNA vaccines were imported into Australia and not manufactured there, the Gene Technology Act does not apply. The speaker disagrees, citing Pfizer's statement about transfection being a part of gene therapy. The regulator suggests a difference in the definition of gene therapy.

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Australia has administered over 60 million vaccine doses to over 20 million people. Despite this, governmental health authorities have chosen not to monitor new or emerging cancer trends, and have failed to make post-vaccination cancer trend data publicly available, which is a critical oversight. Given the massive contamination levels of rogue residual DNA in the Australian vials, we must expect an ongoing rise in cancers and other genetic disorders in Australia. This is a potential long-term health crisis. This matter must be taken seriously. We must advocate for immediate public health responses and monitoring of these trends. Without action, Australians are vulnerable to preventable diseases that may devastate families and strain our healthcare system. These gene-based vaccines should never have been considered. The technology had never been proven to be effective in preventing coronavirus infections and was unsafe long before 2021.

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Australia has administered over 60 million vaccine doses to more than 20 million people, yet health authorities have not monitored cancer trends post-vaccination. The lack of publicly available data on these trends raises concerns about public health oversight. Given the contamination levels of residual DNA in the vaccines, there is a potential for an increase in cancers and genetic disorders, posing a long-term health crisis. Immediate public health responses are necessary to monitor these trends and protect Australians from preventable diseases that could overwhelm the healthcare system. The use of gene-based vaccines raises questions, as their effectiveness in preventing coronavirus infections had not been proven, and safety concerns existed prior to their use in 2021.

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Alden and colleagues found that Pfizer's genetic code can be integrated into the human genome within an hour in a cancerous cell line. This suggests that Pfizer and Moderna's genetic material might become a permanent part of human DNA. There is no study confirming or denying this possibility. The concern is that if eggs or sperm incorporate this genetic code, it could be passed on to future generations. This lack of research is seen as reckless and worrisome.

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The panel discusses replication (replicon) vaccines and their potential dangers, focusing on how they differ from conventional messenger RNA (mRNA) vaccines and what new risks might emerge as this technology develops. Key points and concerns raised - Replicon vaccines concept and fundamental differences - Replicon vaccines use replication-capable genetic material, so the embedded genetic information not only makes antigen proteins but also multiplies inside the cell. They are described as having both constitutive function (the ability to make proteins) and, crucially, the capacity to replicate, which distinguishes them from traditional, non-replicating mRNA vaccines. - It is explained that replication introduces additional mutation and recombination opportunities, because the RNA genome is copied more than once, and the process can produce variants that differ from the original design. - Central dogma exceptions and viral biology - The speakers explain that while the central dogma (DNA → RNA → protein) generally governs biology, some viruses violate this, with RNA viruses that replicate via RNA-dependent replication and even some reverse-transcribing retroviruses that convert RNA to DNA and integrate into genomes. This context is used to frame why replicon vaccines could behave unpredictably. - Potential risks of replication and spread - A core concern is that the replicon approach might allow the vaccine genome to spread beyond the initial target cells, potentially reaching other cells and tissues, or even spreading to other people via exosomes or other means. Exosomes can transport DNA, RNA, and proteins between cells; thus, the replicon genome could in theory be disseminated. - The possibility of homologous or heterologous recombination between replicon genomes and wild-type viruses could yield new variants. The panel emphasizes the difficulty of controlling such recombination in a living system. - Specific material and design considerations - The use of viral components like spike protein genes in replicon vaccines raises concerns about how these proteins might mutate or recombine during replication, potentially altering antigen presentation or safety. - A concern is raised about the lack of repair mechanisms in RNA replication (as opposed to DNA replication), which could make error rates higher and lead to unpredictable changes. - The panel notes that current replicon vaccine designs (including those using alphavirus backbones) inherently carry high mutation and recombination risk, and that the replicating systems may encounter unpredictable evolutionary dynamics inside the human body. - Safety signals and clinical anecdotes - The speakers cite cases of adverse events temporally associated with vaccines, including vascular inflammation and thrombosis, stroke-like events, and myocarditis, to illustrate that immune responses to vaccines can be complex and occasionally severe. They emphasize that such observations do not establish causality, but argue they warrant careful scrutiny. - There are references to cases of acute vascular and neural complications following repeated vaccination, and to broader immune dysregulation phenomena, including IGG4-related disease and immune dysregulation syndromes that can involve multiple organs. - One example concerns a patient who developed sudden limb problems after the third dose, requiring surgery; another describes myocardial involvement after multiple doses and subsequent inflammatory sequelae. - DNA contamination and analytical findings - Kevin McKernan’s analysis of certain Japanese CoronaVac vaccines is cited: both DNA contamination and the presence of SV40 promoter elements were detected in some vaccine lots, with DNA amounts exceeding some regulatory benchmarks in at least one case. The concern is that DNA contamination, or the presence of promoter sequences, could influence integration or expression in unintended ways. - It is noted that vaccines using lipid nanoparticles can potentially deliver nucleic acids into cells; in the presence of exons or promoter sequences, there could be unintended cellular uptake and expression. - Implications for public health and policy - The panel underscores the need for caution, thorough investigation, and long-term observation of any replication-based vaccine platform before broad deployment. There is a call to evaluate risks, monitor long-term outcomes, and consider the possibility that replication-competent constructs could drive unforeseen evolutionary dynamics within hosts or communities. - There is contention about how information is communicated to the public, with particular emphasis on avoiding misinformation while ensuring that scientific uncertainties are transparently discussed. - Broader scientific context and forward-looking stance - The speakers discuss how the field’s approach to gene-based vaccines is evolving rapidly, and they stress that the compatibility of replicon systems with human biology is not yet fully understood. - They frame their discussion as not merely about current vaccines but about the trajectory of vaccine platforms: if replication-based or self-dispersing systems prove too risky or unpredictable, the prudent path might be to favor conventional, non-replicating strategies until safety, efficacy, and containment of unintended spread are more firmly established. Closing and takeaways - The session closes with emphasis on careful evaluation of replicon vaccines, awareness that viral genetics can behave differently in humans than in theory, and a call for continued discussion, independent verification, and transparent communication as the technology develops. - Throughout, speakers acknowledge the complexity of immune responses to vaccines, the potential for unexpected adverse events, and the importance of safeguarding public health while advancing vaccine science.

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Kevin discovered that the vials used for vaccines are contaminated with bacterial DNA. This is concerning because the modified RNA used in these vaccines creates unusual genetic structures that don't occur naturally. Normally, DNA is in a double helix form, but with modified RNA, there are three strands attached to the DNA. The enzyme used to remove DNA, called DNase, cannot digest these triple-stranded genetic constructs, resulting in DNA contamination in the shots. Pfizer and Moderna should have addressed this issue during the manufacturing process by using different enzymes. This shows that assumptions cannot be made when working with new, unnatural products. The DNA used to manufacture the modified RNA was not properly removed, leading to multiple scary aspects of contamination.

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Nicholas Holcher, an epidemiologist and foundation administrator at the McCullough Foundation, appears on the WiderWake Media Podcast to discuss what he calls harms from the mRNA COVID vaccines and to critique mainstream approaches to the pandemic and public health policy. - Vaccine definitions and mRNA technology - Pre-2000 definition: a vaccine is an injectable or oral product that introduces a killed part of a virus or an inactivated form to the body so that encountering a wild-type version would not infect or would cause a less severe illness. - He asserts that mRNA injections are not vaccines: they are a gene transfer platform using modified messenger RNA with long persistence in the body (via N1-methylpseudouridine), delivered in lipid nanoparticles. He claims these bubbles distribute systemically, including to the brain, heart, bone marrow, and reproductive system, and that they instruct cells to produce a spike protein, effectively turning organs into “toxic spike protein production factories.” He says this leads to autoimmune attack on those tissues and contributes to adverse events, including myocarditis, strokes, immune destruction, and “turbo cancers.” - History and purpose of mRNA in vaccines - According to Holcher, work on this technology existed for decades but animals testing showed high mortality or sterilization in ferrets and mice, preventing approval except under a declared global emergency. He contends the COVID-19 crisis enabled emergency use authorization across Western countries, with ulterior aims to inject the globe with mRNA technology. - Global impact and uptake - He estimates about 70% of the global population received at least one COVID-19 injection (mRNA or viral vector). He notes Eastern countries used non-mRNA platforms (e.g., AstraZeneca/J&J in some places; Sinovac elsewhere) but that uptake in the West was high. - Harms and evidence - Excess deaths: cites a study by Dennis Brancourt et al. estimating around 17 million deaths worldwide as a result of COVID injections (as of September 2023); he claims US deaths could be in the hundreds of thousands to millions. - Turbo cancers: cites multiple studies in 2023 showing increased risk of seven cancer types (colorectal, bladder, breast, thyroid, prostate, etc.) in vaccinated groups; cites a major cancer journal, OncoTarget, reporting hundreds of turbo cancer cases across 27 countries, with Pfizer contributing most cases. Holcher also mentions his own group’s work with Neo7 Bioscience documenting genomic integration of vaccine-derived mRNA in a stage IV bladder cancer patient (31-year-old woman) with a segment of mRNA found in circulating tumor DNA on chromosome 19; another study reported thousands of dysregulated genes in post-vaccine cancers, including p53, KRAS, and BRCA. - Definition of turbo cancer: per Merrick et al., rapid, aggressive tumor progression with sudden onset and early metastasis, often in younger individuals, and resistant to treatment. - Fertility, pregnancy, and autism - Fertility: cites studies suggesting fertility impacts, including Karaman et al. finding depletion of primordial follicles in rats after mRNA vaccination; Manichi et al. reporting 33% lower conception rates in vaccinated women in Denmark; a study indicating a ~20% drop in sperm concentration and motility with no recovery over five months. - Autism: asserts a large body of evidence linking vaccines to neurodevelopmental disorders, citing a 136-study review with 107 studies finding positive associations between vaccines and neurodevelopmental issues, including autism, attributed to toxicity and immune system disruption, particularly in children with high vaccine exposure and reduced detox capacity (CYP450 impairment). - Other topics tied to vaccines and public response - The COVID-19 period and vaccine skepticism: claims the pandemic catalyzed a large anti-vaccine movement because people were compelled to take an experimental gene therapy product. - Sam Altman and gene editing: discusses Altman’s Preventive venture with the aim to reduce heritable diseases via in utero gene editing but warns of the path to designer babies and the potential for harm in early-iteration edits, citing prior CRISPR experiments on human embryos that produced deformed offspring or nonviable results. - AI, workers, and future society: predicts two-tier society with implanted or enhanced individuals and a replacement of human labor by robots and AI systems; discusses military and surveillance ambitions in gene editing and AI augmentation. - Mental health and digital life: references a randomized trial showing that turning off mobile Internet improved depression scores and well-being to an extent comparable to or greater than antidepressants. - World Health Organization (WHO): notes the US has pulled out of the WHO, arguing this is good for the US but potentially harmful for others still in the organization; expresses concerns about the pandemic treaty and ongoing global health governance, including vaccine passport-style surveillance. - FDA and public health policy: acknowledges some shifts (e.g., cutting doses from the childhood schedule) but argues the FDA remains compromised and too aligned with vaccine industry interests; criticizes the removal of a potential black box warning for vaccines and calls for more accountability. - Resources and contact - Holcher invites listeners to follow him on X (Twitter) at @nichulsher and to read their work on focalpoints.com and through McCullough’s network. Note: The transcript presents Holcher’s claims and interpretations about vaccines, turbo cancers, autism, fertility, and policy changes. The summary reproduces these points without endorsement or evaluation.

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Pfizer has been forced to release previously secret documents, including FDA approval packages, due to court orders and successful FOIA requests. These documents reveal that Pfizer tested different versions of their vaccine during preclinical and clinical trials, which goes against FDA guidance. The different versions included modified RNA, unmodified RNA, self-amplifying RNA, and Spike protein alone. Surprisingly, all these versions were tested under the same investigational new drug number, despite FDA guidance stating that multiple versions should have their own individual numbers. Additionally, the toxicity of the mRNA active ingredient in the COVID-19 vaccines was never studied. This raises concerns about the regulatory process and the lack of safety testing.
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