COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign

Cureus, Journal Year: 2024, Volume and Issue: unknown

Published: Jan. 24, 2024

Our understanding of COVID-19 vaccinations and their impact on health mortality has evolved substantially since the first vaccine rollouts. Published reports from original randomized phase 3 trials concluded that mRNA vaccines could greatly reduce symptoms. In interim, problems with methods, execution, reporting these pivotal have emerged. Re-analysis Pfizer trial data identified statistically significant increases in serious adverse events (SAEs) group. Numerous SAEs were following Emergency Use Authorization (EUA), including death, cancer, cardiac events, various autoimmune, hematological, reproductive, neurological disorders. Furthermore, products never underwent adequate safety toxicological testing accordance previously established scientific standards. Among other major topics addressed this narrative review are published analyses harms to humans, quality control issues process-related impurities, mechanisms underlying (AEs), immunologic basis for inefficacy, concerning trends based registrational data. The risk-benefit imbalance substantiated by evidence date contraindicates further booster injections suggests that, at a minimum, should be removed childhood immunization program until proper studies conducted. Federal agency approval blanket-coverage population-wide had no support an honest assessment all relevant commensurate consideration risks versus benefits. Given extensive, well-documented unacceptably high harm-to-reward ratio, we urge governments endorse global moratorium modified questions pertaining causality, residual DNA, aberrant protein production answered.

Language: Английский

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COVID-19 Modified mRNA “Vaccines”: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex, Part 1

International Journal of Vaccine Theory Practice and Research, Journal Year: 2024, Volume and Issue: 3(2), P. 1112 - 1178

Published: June 29, 2024

Our understanding of COVID-19 synthetic, modified mRNA (modmRNA) products and their public health impact has evolved substantially since December 2020. Published reports from the original randomized placebo-controlled trials concluded that modmRNA injections could greatly reduce symptoms. However, premature termination both obviated any reliable assessment potential adverse events due to an insufficient timeframe for proper safety evaluation. Following authorization global distribution, problems with methods execution have emerged. The usual testing protocols toxicology requirements were bypassed. Many key trial findings either misreported or omitted entirely published reports. By implication, secondary estimates excess morbidity mortality in must be deemed underestimates. Rigorous re-analyses data post-marketing surveillance studies indicate a substantial degree modmRNA-related harms than was initially reported. Confidential Pfizer documents had revealed 1.6 million by August 2022. A third serious injuries cardiovascular, neurological, thrombotic, immunological, reproductive systems, along alarming increase cancers. Moreover, well-designed shown repeated cause immune dysfunction, thereby potentially contributing heightened susceptibility SARS-CoV-2 infections increased risks COVID-19. This paper also discusses insidious influence Bio-Pharmaceutical Complex, closely coordinated collaboration between organizations, pharmaceutical companies, regulatory agencies. We recommend moratorium on until toxicological are conducted.

Language: Английский

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SARS-CoV-2: A Glance at the Innate Immune Response Elicited by Infection and Vaccination

Antibodies, Journal Year: 2024, Volume and Issue: 13(1), P. 13 - 13

Published: Feb. 8, 2024

The COVID-19 pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has led to almost seven million deaths worldwide. SARS-CoV-2 causes infection through respiratory transmission and can occur either without any symptoms or with clinical manifestations which be mild, severe or, in some cases, even fatal. Innate immunity provides the initial defense against virus sensing pathogen-associated molecular patterns triggering signaling pathways that activate antiviral inflammatory responses, limit viral replication help identification removal of infected cells. However, temporally dysregulated excessive activation innate immune response is deleterious for host associates COVID-19. In addition its defensive role, pivotal priming adaptive polarizing effector function. This capacity relevant context both natural vaccination. Here, we provide an overview current knowledge responses

Language: Английский

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Increased Age-Adjusted Cancer Mortality After the Third mRNA-Lipid Nanoparticle Vaccine Dose During the COVID-19 Pandemic in Japan

Cureus, Journal Year: 2024, Volume and Issue: unknown

Published: April 8, 2024

During the COVID-19 pandemic, excess deaths including cancer have become a concern in Japan, which has rapidly aging population. Thus, this study aimed to evaluate how age-adjusted mortality rates (AMRs) for different types of Japan changed during pandemic (2020-2022). Official statistics from were used compare observed annual and monthly AMRs with predicted based on pre-pandemic (2010-2019) figures using logistic regression analysis. No significant was first year (2020). However, some mortalities 2021 after mass vaccination second vaccine doses, all cancers specific (including ovarian cancer, leukemia, prostate lip/oral/pharyngeal pancreatic breast cancer) third dose 2022. four most (lung, colorectal, stomach, liver) showed decreasing trend until 2020, but rate decrease slowed This discusses possible explanations these increases rates.

Language: Английский

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Changes and Long-Term Effects of the Immune System after COVID-19 Infection

Theoretical and Natural Science, Journal Year: 2025, Volume and Issue: 69(1), P. 78 - 84

Published: Jan. 15, 2025

Following the pandemic in 2020, physical health has generally declined. All of this is brought on by modifications to body's immune system and consequences sequelae. The current research gap caused neglect COVID-19's after effects. In paper, relationship between changes, complications their conditions was studied, preliminary results harm prevention sequelae were obtained. system's alterations during epidemic infection its are main topics article, including cytokine storms, inflammatory responses, changes cells. At same time, article explores underlying conditions, such as chronic diseases autoimmune diseases, they cause. Through observation analysis later stages epidemic, reasons for general decline people's fitness system. future, it hoped that there will be improvements disease measures diseases.

Language: Английский

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Expression of SARS-CoV-2 spike protein in cerebral Arteries: Implications for hemorrhagic stroke Post-mRNA vaccination

Journal of Clinical Neuroscience, Journal Year: 2025, Volume and Issue: 136, P. 111223 - 111223

Published: April 4, 2025

The rapid deployment of mRNA vaccines for SARS-CoV-2, such as BNT162b2 (BioNTech-Pfizer) and mRNA-1273 (Moderna), provided a critical tool in combating the COVID-19 pandemic. While their short-term safety efficacy were demonstrated clinical trials, rare adverse events, including hemorrhagic strokes, have been reported after widespread use. However, long-term biodistribution effects remain underexplored. This study aimed to investigate presence SARS-CoV-2 spike protein brain tissues patients with examining its potential association vaccination. A total 19 cases stroke from 2023 2024 retrospectively analyzed. Immunohistochemical staining nucleocapsid was performed on tissue samples. In situ hybridization conducted selected confirm origin expression (vaccine or viral infection). Vaccination history infection status documented all cases. Spike detected 43.8 % vaccinated patients, predominantly localized intima cerebral arteries, even up 17 months post-vaccination. no active inflammatory changes identified, infiltration CD4-, CD8- CD68- positive cells observed vessels. confirmed both vaccine-derived virus-derived mRNA, which encode protein, select Notably, positivity exclusively female (P = 0.015). None showed positivity, supporting absence infection. Although possibility due asymptomatic cannot be entirely excluded, this prolonged arteries following Additionally, some cell spike-positive These findings raise significant concerns regarding lipid nanoparticle-based safety. Global replication studies are urgently required validate these ensure comprehensive evaluations vaccines.

Language: Английский

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Altered Circulating Cytokine Profile Among mRNA‐Vaccinated Young Adults: A Year‐Long Follow‐Up Study

Immunity Inflammation and Disease, Journal Year: 2025, Volume and Issue: 13(4)

Published: April 1, 2025

ABSTRACT Objectives This longitudinal study aimed to assess the impact of COVID‐19 vaccination on cytokine profile. Methods A total 84 Saudi subjects (57.1% females) with mean age 27.2 ± 12.3 participated in this study. Anthropometric data and fasting blood samples were obtained at baseline after final vaccination, an average follow‐up duration 14.1 3.6 months for adolescents 13.3 3.0 adults, calculated from first dose vaccination. Assessment profiles was done using commercially available assays. Results After follow‐up, a significant increase weight body mass index observed overall ( p = 0.003 0.002, respectively). Postvaccination, increases several cytokines, including basic fibroblast growth factor 2 < 0.001), interferon gamma (IFNγ) 0.005), interleukin‐1 beta (IL1β) IL4 IL6 0.003), IL7 IL17E monocyte chemoattractant protein‐1 (MCP1) 0.03), MCP3 tumor necrosis alpha (TNFα) VEGFA 0.001). reduction only macrophage colony‐stimulating When adjusted age, epidermal (EGF), IL4, IL6, MCP3, TNFα, vascular endothelial (VEGFA) remained statistically significant. Gender‐based analysis revealed that men experienced greater 0.008), 0.04), TNFα 0.015) compared women. Age‐based showed older participants had more pronounced EGF 0.011), 0.029), MCP1 0.042), 0.017), while younger 0.025). Conclusions The findings indicated resulted levels, which signifies persistence humoral immune response messenger RNA (mRNA) vaccines. effect may be attributed persistent production spike protein highly inflammatory nature mRNA–lipid nanoparticle. Additionally, results suggested differences levels based gender age. Notably, profile remains favorably altered young adults who received mRNA vaccinations, even 1 year.

Language: Английский

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Thrombosis With Thrombocytopenia and Post-COVID-Vaccination Syndrome With Anti-G-Protein-Coupled Receptor (GPCR) Antibodies Treated With Therapeutic Plasma Exchange

Cureus, Journal Year: 2024, Volume and Issue: unknown

Published: May 10, 2024

We present the case of a female who developed cerebral venous thrombosis with thrombocytopenia after inoculation anti-coronavirus disease 2019 (COVID-19) Vaxzevria vaccine, followed by splanchnic and diffuse hemorrhages. Despite receiving treatment, complications increased, hence therapeutic plasma exchange (TPE) was attempted, leading to laboratory clinical improvements discharge period intensive care. Almost two years first episode, in interim which patient complained only minor symptoms such as asthenia difficulty concentrating, she an epileptic syndrome that required neurological treatment. In addition, her fatigue concentrating worsened other serious dysautonomia appeared, trembling right arm, loss stability, postural orthostatic tachycardia. As serum analysis revealed significant number alterations autoantibodies against various G-protein-coupled receptors (GPCRs) RAS-related proteins, further TPEs were performed, resulting rapid sustained improvement. This report highlights role different types produced response anti-COVID-19 vaccination, can have functional, regulatory, possibly pathogenic effects on vascular nervous systems.

Language: Английский

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COVID-19 Modified mRNA “Vaccines”: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex, Part 2

International Journal of Vaccine Theory Practice and Research, Journal Year: 2024, Volume and Issue: 3(2), P. 1275 - 1344

Published: Aug. 16, 2024

The COVID-19 modified mRNA (modmRNA) lipid nanoparticle-based “vaccines” are not classical antigen-based vaccines but instead prodrugs informed by gene therapy technology. Of considerable note, these products have been linked to atypical adverse and serious event profiles. As discussed in Part 1, health-related risks drawbacks were drastically misreported underreported the Pfizer Moderna trial evaluations of genetic products. Now 2, we examine main structural functional aspects injectables. modmRNA injectable introduce a unique set biological challenges human body with potential induce an extensive range adverse, crippling, life-threatening effects. Based on fact that there is no current method quantify host (cell-based) spike protein production vivo following injection prodrugs, standard “dose”. This part due differences output, which depends cell metabolism transfection efficiency. It therefore difficult predict profiles individual basis, considering millions adults across world reported severe events context products, valid concerns raised regarding infants younger age groups for whom poses only minimal risks. We address process-related impurities inherent mass posed contaminants. then categorize principal associated brief systems-based synopsis each six domains harms: (1) cardiovascular, (2) neurological, (3) hematologic; (4) immunological, (5) oncological, (6) reproductive. conclude discussion primary public health regulatory issues arising from this evidence-informed synthesis literature reiterate urgency imposing global moratorium modmRNA-LNP-based platform.

Language: Английский

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Concerns regarding Transfusions of Blood Products Derived from Genetic Vaccine Recipients and Proposals for Specific Measures

Published: March 15, 2024

The coronavirus pandemic was declared by the World Health Organization (WHO) in 2020, and a global genetic vaccination program has been rapidly implemented as fundamental solution. However, many countries around world have reported that so-called vaccines, such those using modified mRNA encoding spike protein lipid nanoparticles drug delivery system, resulted post-vaccination thrombosis subsequent cardiovascular damage, well wide variety of diseases involving all organs systems, including nervous system. In this article, based on these circumstances volume evidence recently come to light, we call attention medical professionals various risks associated with blood transfusions products derived from people who suffered long COVID vaccine recipients, received make proposals regarding specific tests, testing methods, regulations deal risks. We expect proposal will serve basis for discussion how address syndrome its consequences following programs.

Language: Английский

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