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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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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Policies on children and schools during the SARS-CoV-2 pandemic in Western Europe

Frontiers in Public Health, Год журнала: 2023, Номер 11

Опубликована: Июль 25, 2023

During the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), mitigation policies for children have been a topic of considerable uncertainty and debate. Although some co-morbidities which increase their risk disease (COVID-19), complications such as multisystem inflammatory long COVID, most only get mild COVID-19. On other hand, consistent evidence shows that mass measures had enormous adverse impacts on children. A central question can thus be posed: What amount should bear, in response to is disproportionally affecting older people? In this review, we analyze distinct child versus adult epidemiology, policies, trade-offs outcomes Western Europe. The highly heterogenous European applied compared adults did not lead significant measurable differences outcomes. Remarkably, relative epidemiological importance transmission from school-age age groups remains uncertain, with current suggesting schools often follow, rather than lead, community transmission. Important learning points future pandemics are summarized.

Язык: Английский

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Quantitative Benefit–Risk Assessment of Vaccination Against COVID‐19: A Systematic Review

Pharmacoepidemiology and Drug Safety, Год журнала: 2025, Номер 34(2)

Опубликована: Янв. 29, 2025

ABSTRACT Purpose With the introduction of COVID‐19 vaccines, there has been a proliferation quantitative benefit‐risk assessments (qBRAs). Prior work on other types vaccines found that published qBRAs have not always clearly reported methods and/or results needed to assist in application qBRA findings. The aim was systematically identify, review, and critically assess vaccine qBRA. ultimate goal is support future development robust for existing, new, updated vaccines. Methods We reviewed identified from multiple sources through April 17, 2023, including literature databases, selected Health Authority websites, grey search. assessed whether key features typical were presented these reports. Results 37 screening 2220 publications 18 sources. conducted two mRNA adenoviral vector Only one represented low‐ middle‐income countries. Although many used simple calculations ( n = 25), more complex models 15 Simple approaches able employ stratification by age sex highlight safety issues affecting specific demographic groups scenarios account changes viral transmission effectiveness over time. Details regarding data analytic missing or limited some Conclusions This comprehensive description critical assessment together with available guidance can be transparent qBRAs.

Язык: Английский

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COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province

Vaccines, Год журнала: 2022, Номер 11(1), С. 31 - 31

Опубликована: Дек. 23, 2022

This cohort study on the entire population of an Italian Province assessed incidence potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due several cardiovascular diseases, pulmonary embolism, deep vein thrombosis from National Healthcare System official data. During follow-up, 5743 individuals died, 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show increased risk all-cause death, non-COVID or any PVR-SAEs, as compared unvaccinated 56,494). These results consistent across genders, age-classes, vaccine types, SARS-CoV-2 infection status vary in Cox models adjusting age, gender, infection, selected comorbidities. In infected population, dose was associated with a lower likelihood death PVR-SAE. uninfected who received one two doses showed significantly higher most outcomes, likely large selection bias introduced restriction policies targeting less than three doses. conclusion, increase mortality PVR-SAEs incidence. Further research is warranted evaluate long-term safety vaccines.

Язык: Английский

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Rational harm‐benefit assessments by age group are required for continued COVID‐19 vaccination

Scandinavian Journal of Immunology, Год журнала: 2022, Номер 98(1)

Опубликована: Дек. 22, 2022

Язык: Английский

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Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases, in Patients with Cardiac Issues, and in the Healthy Population

Pathogens, Год журнала: 2023, Номер 12(2), С. 233 - 233

Опубликована: Фев. 2, 2023

The coronavirus disease 2019 (COVID-19) has been a challenge for the whole world since beginning of 2020, and COVID-19 vaccines were considered crucial eradication. Instead producing classic vaccines, some companies pointed to develop products that mainly function by inducing, into host, production antigenic protein SARS-CoV-2 called Spike, injecting an instruction based on RNA or DNA sequence. Here, we aim give overview safety profile actual known adverse effects these in relationship with their mechanism action. We discuss use at-risk people, especially those autoimmune diseases previously reported myocarditis, but also general population. debate real necessity administering unclear long-term people conditions, as well healthy at time omicron variants. This, considering existence therapeutic interventions, much more clearly assessed present compared past, relatively lower aggressive nature new viral

Язык: Английский

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Wearing masks is easy but taking them off is difficult – A situation in Japan during COVID-19 pandemic and after

Dialogues in Health, Год журнала: 2024, Номер 4, С. 100172 - 100172

Опубликована: Фев. 3, 2024

Masks are well accepted in Japan, where they were already part of daily life even before the COVID-19 pandemic. Unlike many other countries mask mandates lifted as soon pandemic was under control, Japan one last to ease mask-wearing guidelines. Even after formal announcement allow masks-off mid-March 2023, Japanese still voluntarily wear masks. In this work, possible reasons for extreme "mask-affinity" people studied by exploring various information sources including tweets (now known X posts) and subsequent text-analysis, online news, medical literature. An observational study conducted based on prospectively collected during 5 months from June 26th, 2022 November 2022. Tweets with hashtag "mask (in Japanese)" weekly via Twitter application programming interface using R version 4.0.3 gauge public opinions. The word clouds intuitive understanding key words drawn tokenized text. data collection period included 7th flareups newly infected cases i.e. "the surge". total, 161,592 collected. Word 1) surge 18,000 26th 2) during/after 143,592 between July-November created package "wordcloud2". results indicated that wanted take off masks due heat summer, then shifted again toward along but a certainly growing "no-mask" sentiment. Subsequent review domestic suggested factors, not only well-known peer pressure, may have contributed public's affinity Japan. This work revealed an aspect struggle adaptation unexpected focusing our closest adjunct over past 3 years isolation. Trial registration: applicable.

Язык: Английский

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How denialist amplification spread COVID misinformation and undermined the credibility of public health science

Journal of Public Health Policy, Год журнала: 2024, Номер 45(1), С. 114 - 125

Опубликована: Фев. 22, 2024

Язык: Английский

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Recurrent cardiac tamponade following coronavirus disease 2019 mRNA vaccination: a case report

Cardiovascular Pathology, Год журнала: 2024, Номер 72, С. 107668 - 107668

Опубликована: Июнь 10, 2024

Язык: Английский

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