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      Review of adverse events associated with COVID-19 vaccines, highlighting their frequencies and reported cases

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          Abstract

          This review examines the immunological and autoimmune adverse events associated with COVID-19 vaccines, highlighting their frequencies, reported cases, and associations with specific vaccine classes. The concept of vaccine-induced immune thrombotic thrombocytopenia is crucial in addressing vaccine skepticism. Understanding this concept helps healthcare professionals identify and manage potential adverse events after vaccination. Despite their rarity, immunological and autoimmune adverse events cause concern and anxiety among the public. To maintain public trust in vaccination programs, healthcare professionals and public health agencies must actively monitor and address these adverse events, promptly disclose suspicious incidents, take measures to mitigate dangers, and inform the public with transparency and accurate information. Continuing research and surveillance are essential for understanding the underlying mechanisms of these adverse events and developing strategies to minimize their occurrence.

          الملخص

          تتناول هذه المراجعة الأحداث الجانبية السلبية المرتبطة بالجهاز المناعي والأمراض المناعية الذاتية (التي تعرف بالأحداث الجانبية السلبية بعد التطعيم) المرتبطة بلقاحات كوفيد-19، وتسلط الضوء على تكرارها، والحالات المبلغ عنها، والصلة مع فئات اللقاحات المحددة. مفهوم "قلة الصفيحات الجلطية المناعية المستحثة باللقاح" مهم في التعامل مع التشكك في اللقاحات. فهم هذه المفاهيم يساعد العاملين في الرعاية الصحية على تحديد وإدارة الأحداث الجانبية المحتملة بعد التطعيم. على الرغم من ندرتها، يمكن أن تسبب الأحداث الجانبية السلبية بعد التطعيم قلقا وتوترا بين المجتمع. يجب على العاملين في الرعاية الصحية والوكالات الصحية العامة مراقبة هذه الأحداث بنشاط والتعامل معها للحفاظ على ثقة المجتمع في برامج التطعيم. يتضمن ذلك الكشف السريع عن الحوادث المشبوهة، وتبني إجراءات للتخفيف من الأخطار، وإبلاغ المجتمع بمعلومات دقيقة وشفافة. البحث المستمر والمراقبة أمران ضروريان لفهم الآليات الممكنة وراء هذه الأحداث الجانبية وتطوير استراتيجيات لتقليل حدوثها.

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          Most cited references64

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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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            The COVID-19 vaccine development landscape

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              SARS-CoV-2 Vaccines: Status Report

              SARS-CoV-2, the causal agent of COVID-19, first emerged in late 2019 in China. It has since infected more than 870,000 individuals and caused more than 43,000 deaths globally. Here, we discuss therapeutic and prophylactic interventions for SARS-CoV-2 with a focus on vaccine development and its challenges. Vaccines are being rapidly developed but will likely come too late to affect the first wave of a potential pandemic. Nevertheless, critical lessons can be learned for the development of vaccines against rapidly emerging viruses. Importantly, SARS-CoV-2 vaccines will be essential to reducing morbidity and mortality if the virus establishes itself in the population.
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                Author and article information

                Contributors
                Journal
                J Taibah Univ Med Sci
                J Taibah Univ Med Sci
                Journal of Taibah University Medical Sciences
                Taibah University
                1658-3612
                05 September 2023
                December 2023
                05 September 2023
                : 18
                : 6
                : 1646-1661
                Affiliations
                [1]Department of Pharmaceutical Chemistry, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamilnadu, India
                Author notes
                []Corresponding address: Department of Pharmaceutical Chemistry, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamilnadu, India. karthikeyanelumalai@ 123456hotmail.com
                Article
                S1658-3612(23)00128-2
                10.1016/j.jtumed.2023.08.004
                10507236
                37732332
                177b0657-163f-425f-9b50-dab2225178e6
                © 2023 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 21 May 2023
                : 14 July 2023
                : 28 August 2023
                Categories
                Review Article

                تطعيم كوفيد-19,التهاب العضلة القلبية,الآثار الجانبية الدورية,التطعيم,الالتهاب,covid-19 vaccination,myocarditis,circulatory adverse effects,immunization,inflammation,healthcare professionals

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