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

Cureus, Год журнала: 2024, Номер unknown

Опубликована: Янв. 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.

Язык: Английский

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Determinants of COVID-19 vaccine-induced myocarditis

Therapeutic Advances in Drug Safety, Год журнала: 2024, Номер 15

Опубликована: Янв. 1, 2024

Background: Following the roll-out of Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in United States, millions individuals have reported adverse events (AEs) using vaccine reports system (VAERS). The objective this analysis is to describe myocarditis data VAERS COVID-19 vaccines as potential determinants myocarditis. Methods: We used examine frequency reporting since beginning mass vaccination campaign compared with historical values administration from Our World Data database. examined context sex, age, dose. Statistical was done Student’s t-test determine statistically significant differences between ages among chi-square test relationships categorical variables statistical significance. Results: found number after 2021 223 times higher than average all combined for past 30 years. This represented a 2500% increase absolute first year when comparing prior 2021. Demographic revealed that occurred most youths (50%) males (69%). A total 76% cases resulted emergency care hospitalization. Of reports, 92 died (3%). Myocarditis more likely dose 2 ( p < 0.00001) less years age were older acquire 0.00001). Conclusion: strongly associated serious safety signal myocarditis, particularly children young adults resulting hospitalization death. Further investigation into underlying mechanisms vaccine-induced imperative create effective mitigation strategies ensure programs across populations.

Язык: Английский

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The mRNA-LNP vaccines – the good, the bad and the ugly?

Frontiers in Immunology, Год журнала: 2024, Номер 15

Опубликована: Фев. 8, 2024

The mRNA-LNP vaccine has received much attention during the COVID-19 pandemic since it served as basis of most widely used SARS-CoV-2 vaccines in Western countries. Based on early clinical trial data, these were deemed safe and effective for all demographics. However, latest data raise serious concerns about safety effectiveness vaccines. Here, we review some efficacy identified to date. We also discuss potential mechanism observed adverse events related use whether they can be mitigated by alterations this approach.

Язык: 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, Год журнала: 2024, Номер 3(2), С. 1112 - 1178

Опубликована: Июнь 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.

Язык: Английский

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Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination

Cureus, Год журнала: 2023, Номер unknown

Опубликована: Ноя. 21, 2023

The spike protein of SARS-CoV-2 has been found to exhibit pathogenic characteristics and be a possible cause post-acute sequelae after infection or COVID-19 vaccination. vaccines utilize modified, stabilized prefusion that may share similar toxic effects with its viral counterpart. aim this study is investigate mechanisms harm biological systems from vaccine-encoded propose mitigation strategies. We searched PubMed, Google Scholar, ‘grey literature’ find studies (1) investigated the on systems, (2) helped differentiate between vaccine-generated proteins, (3) identified detoxification protocols compounds had signals benefit acceptable safety profiles. abundant evidence damage in cardiovascular, hematological, neurological, respiratory, gastrointestinal, immunological systems. Viral proteins have shown play direct role cardiovascular thrombotic injuries both Detection for at least 6-15 months vaccination those indicates as primary contributing factor long COVID. rationalized these findings give support potential long-term post-infection and/or vaccine-induced complications. base protocol, composed oral nattokinase, bromelain, curcumin. This approach holds immense promise clinical care, upon which additional therapeutic agents are applied goal aiding resolution Large-scale, prospective, randomized, double-blind, placebo-controlled trials warranted order determine relative risks benefits protocol.

Язык: 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, Год журнала: 2024, Номер unknown

Опубликована: Апрель 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.

Язык: Английский

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Diagnostik und Therapie bei Post-COVID-19 und Post-Vaccination-Syndrom

Deutsche Zeitschrift für Akupunktur, Год журнала: 2025, Номер unknown

Опубликована: Янв. 6, 2025

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Efficacy of Vitamin D Replacement Therapy on 28 Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome After COVID-19 Vaccination

Nutrition, Год журнала: 2025, Номер 134, С. 112718 - 112718

Опубликована: Фев. 19, 2025

Prolonged symptoms have been reported following both COVID-19 infection and vaccination, with some cases leading to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Of 80 patients presenting our hospital postvaccination syndrome, 28 met the diagnostic criteria for ME/CFS. We conducted a retrospective study on these patients. measured serum 25-hydroxyvitamin D levels in who developed ME/CFS after vaccination between August 2022 February 2024. Vitamin replacement therapy included dietary counseling, sun exposure recommendations, oral vitamin supplementation. evaluated changes blood symptom improvement. At initial visit, 27 of diagnosed had insufficient or deficient (16 ± 4 ng/mL, mean SD). Following therapy, we observed an increase (28 5 ng/mL) associated decrease (from 10.3 2.1 3.3 2.0). Notably, 23 (82%) no longer therapy. Among symptoms, sleep problems showed most improvement (71%), followed by autonomic (68%). For developing levels, appropriate under medical guidance may lead symptomatic relief. are preparing randomized controlled trial evaluate efficacy individuals deficiency vaccination.

Язык: Английский

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Risk stratification for future cardiac arrest after COVID-19 vaccination

World Journal of Cardiology, Год журнала: 2025, Номер 17(2)

Опубликована: Фев. 24, 2025

Unheralded cardiac arrest among previously healthy young people without antecedent illness, months or years after coronavirus disease 2019 (COVID-19) vaccination, highlights the urgent need for risk stratification. The most likely underlying pathophysiology is subclinical myopericarditis and reentrant ventricular tachycardia spontaneous fibrillation that commonly precipitated a surge in catecholamines during exercise waking hours of terminal sleep. Small patches inflammation and/or edema can be missed on imaging autopsy, heart appear grossly normal. This paper reviews evidence linking COVID-19 vaccines to where unfortunately majority victims have had no clinical evaluation. We propose comprehensive strategy evaluating cardiovascular post-vaccination, incorporating detailed patient history, antibody testing, diagnostics best attempt detect abnormalities before sudden death. approach aims identify individuals at higher events vaccination guide appropriate management. It prudent each primary care physician pre-established plan when addressing this issue their practice.

Язык: Английский

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mRNA-based vaccines and therapies - a revolutionary approach for conquering fast-spreading infections and other clinical applications: a review

International Journal of Biological Macromolecules, Год журнала: 2025, Номер unknown, С. 143134 - 143134

Опубликована: Апрель 1, 2025

Язык: Английский

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