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      Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine - Part 1

      review-article
      1 ,
      Journal of Insulin Resistance
      AOSIS
      COVID-19, mRNA vaccine, cardiac arrests, real evidence-based medicine, shared decision-making

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          Abstract

          Background

          In response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several new pharmaceutical agents have been administered to billions of people worldwide, including the young and healthy at little risk from the virus. Considerable leeway has been afforded in terms of the pre-clinical and clinical testing of these agents, despite an entirely novel mechanism of action and concerning biodistribution characteristics.

          Aim

          To gain a better understanding of the true benefits and potential harms of the messenger ribonucleic acid (mRNA) coronavirus disease (COVID) vaccines.

          Methods

          A narrative review of the evidence from randomised trials and real world data of the COVID mRNA products with special emphasis on BionTech/Pfizer vaccine.

          Results

          In the non-elderly population the “number needed to treat” to prevent a single death runs into the thousands. Re-analysis of randomised controlled trials using the messenger ribonucleic acid (mRNA) technology suggests a greater risk of serious adverse events from the vaccines than being hospitalised from COVID-19. Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascular safety. Mirroring a potential signal from the Pfizer Phase 3 trial, a significant rise in cardiac arrest calls to ambulances in England was seen in 2021, with similar data emerging from Israel in the 16–39-year-old age group.

          Conclusion

          It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally. A pause and reappraisal of global vaccination policies for COVID-19 is long overdue.

          Contribution

          This article highlights the importance of addressing metabolic health to reduce chronic disease and that insulin resistance is also a major risk factor for poor outcomes from COVID-19.

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          Most cited references34

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection

            Although myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1–28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1–28 days postvaccination period, and after a SARS-CoV-2 positive test. We estimated an extra two (95% confidence interval (CI) 0, 3), one (95% CI 0, 2) and six (95% CI 2, 8) myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 (95% CI 38, 41) myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test. We also observed increased risks of pericarditis and cardiac arrhythmias following a positive SARS-CoV-2 test. Similar associations were not observed with any of the COVID-19 vaccines, apart from an increased risk of arrhythmia following a second dose of mRNA-1273. Subgroup analyses by age showed the increased risk of myocarditis associated with the two mRNA vaccines was present only in those younger than 40.
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              SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2

                Author and article information

                Journal
                JIR
                Journal of Insulin Resistance
                AOSIS
                2412-2785
                2519-7533
                26 September 2022
                2022
                : 5
                : 1
                : 71
                Affiliations
                [1 ]Public Health Collaboration, London, United Kingdom
                Author notes
                Corresponding author: Aseem Malhotra, aseem_malhotra@ 123456hotmail.com
                Author information
                https://orcid.org/0000-0002-6901-1539
                Article
                JIR-5-71
                10.4102/jir.v5i1.71
                9557944
                64ee3ec5-5328-42c7-9fb8-3db6ead1f474
                © 2022. The Authors

                Licensee: AOSIS. This work is licensed under the Creative Commons Attribution License.

                History
                : 10 June 2022
                : 01 September 2022
                Categories
                Review Article

                covid-19,mrna vaccine,cardiac arrests,real evidence-based medicine,shared decision-making

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