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      BNT162b2 and ChAdOx1 SARS-CoV-2 Post-vaccination Side-Effects Among Saudi Vaccinees

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          Abstract

          Background: Vaccination against SARS-CoV-2 is important for reducing hospitalization and mortalities. Both Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) vaccines are used in Saudi Arabia and in many parts of the world. Post-vaccinal side effects were recorded, so we aimed to screen different complaints after vaccination among vaccinees in Saudi Arabia.

          Methods: An online questionnaire was designed to screen the local, systemic, and allergic post vaccination reactions for vaccinees who received either one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 vaccine. The number and percentage were recorded for each response and analyzed using cross-tab and Chi square tests. The degree of the severity of post vaccination reactions were analyzed using Roc curve. The cofactors that may affect the severity of post-vaccinal reactions including previous COVID-19 infection, age, sex, body mass index, and comorbidities were investigated.

          Results: During our study, 4,170 individuals reported their responses: 2,601 received one dose of BNT162b2, of whom 456 completed the second dose, and 1,569 received a single dose of ChAdOx1. The side effects were reported in 85.6% of BNT162b2 vaccinees and 96.05% of ChAdOx1 vaccinees who voluntarily responded to a survey about post-vaccination side effects. The side effects were more severe in BNT162b2 than ChAdOx1. ChAdOx1 vaccinees reported mild, moderate, severe and critical side effects in 30.13, 28.62, 29.73, and 1.53%, respectively. In contrast, mild side effects were recorded among the majority of BNT162b2 vaccinees (63.92%) while moderate, severe, and critical side effects were 27.67, 7.68, and 0.72%, respectively. Both local and systemic side effects were recorded more frequently in ChAdOx1 in comparison to BNT162b2 vaccinees. Palpitation was among the new systemic side effects reported in the current study in high frequency. Abnormal menstrual cycle (delaying/increase hemorrhages or pain) was also reported in 0.98% (18/1846) of Pfizer-BioNTech and 0.68% (7/1028) of ChAdOx1 vaccinees, while deep vein thrombosis was only reported in a single case vaccinated with BNT162b2 vaccine.

          Conclusion: Both vaccines induced post-vaccinal side effects; however, ChAdOx1 induces a higher frequency of post-vaccinal systemic side effects than BNT162b2.

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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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            Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China

            Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and has subsequently spread worldwide. Risk factors for the clinical outcomes of COVID-19 pneumonia have not yet been well delineated.
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              OpenSAFELY: factors associated with COVID-19 death in 17 million patients

              COVID-19 has rapidly impacted on mortality worldwide. 1 There is unprecedented urgency to understand who is most at risk of severe outcomes, requiring new approaches for timely analysis of large datasets. Working on behalf of NHS England we created OpenSAFELY: a secure health analytics platform covering 40% of all patients in England, holding patient data within the existing data centre of a major primary care electronic health records vendor. Primary care records of 17,278,392 adults were pseudonymously linked to 10,926 COVID-19 related deaths. COVID-19 related death was associated with: being male (hazard ratio 1.59, 95%CI 1.53-1.65); older age and deprivation (both with a strong gradient); diabetes; severe asthma; and various other medical conditions. Compared to people with white ethnicity, black and South Asian people were at higher risk even after adjustment for other factors (HR 1.48, 1.29-1.69 and 1.45, 1.32-1.58 respectively). We have quantified a range of clinical risk factors for COVID-19 related death in the largest cohort study conducted by any country to date. OpenSAFELY is rapidly adding further patients’ records; we will update and extend results regularly.
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                Author and article information

                Contributors
                Journal
                Front Med (Lausanne)
                Front Med (Lausanne)
                Front. Med.
                Frontiers in Medicine
                Frontiers Media S.A.
                2296-858X
                08 October 2021
                2021
                08 October 2021
                : 8
                : 760047
                Affiliations
                College of Medicine, Taif University , Taif, Saudi Arabia
                Author notes

                Edited by: Reza Lashgari, Shahid Beheshti University, Iran

                Reviewed by: Shyh Poh Teo, Raja Isteri Pengiran Anak Saleha Hospital, Brunei; Flor Pujol, Instituto Venezolano de Investigaciones Científicas (IVIC), Venezuela; AbdulAzeez Adeyemi Anjorin, Lagos State University, Nigeria; Andrew Clark, University of Texas Southwestern Medical Center, United States

                *Correspondence: Ahmed S. Abdel-Moneim asa@ 123456tu.edu.sa ; asa@ 123456bsu.edu.eg

                This article was submitted to Infectious Diseases - Surveillance, Prevention and Treatment, a section of the journal Frontiers in Medicine

                †These authors have contributed equally to this work

                Article
                10.3389/fmed.2021.760047
                8531069
                34692740
                0a05d938-8ab6-4cbf-8978-58be23124ee6
                Copyright © 2021 Alghamdi, Alotaibi, Alqahtani, Al Aboud and Abdel-Moneim.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 17 August 2021
                : 13 September 2021
                Page count
                Figures: 1, Tables: 6, Equations: 0, References: 41, Pages: 10, Words: 6819
                Funding
                Funded by: Taif University, doi 10.13039/501100006261;
                Categories
                Medicine
                Original Research

                covid-19,sars-cov-2,covid vaccines,post vaccination side effects,chadox1 ncov-19 vaccine,bnt162b2 mrna covid-19 vaccine,palpitation,menstrual cycle disturbance

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