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      Safety and reported adverse effects of coronavirus disease-2019 (COVID-19) vaccines in patients with rheumatic diseases

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          Abstract

          Background

          Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms and severity of COVID19 are variable.

          Aim of the work

          To evaluate the effectiveness and to identify side effects of the COVID-19 vaccines among Egyptian patients with autoimmune rheumatic diseases (RDs).

          Patients and methods

          The study included 126 patients with various RDs and 200 control. Detailed medical history was recorded with special concern regarding COVID-19 vaccination, types, doses, side effects, post-vaccination infection and treatment.

          Results

          In patients, BBIBP-CorV (Sinopharm) was the most frequent vaccine 42.3 % (n = 52); CoronaVac (Sinovac) 22 % (n = 27); ChAdOx1 (AstraZeneca) 17.9 % (n = 22); BNT162 (Pfizer BioNTech) 14.6 % (n = 18); Sputnik V 1.6 % (n = 2) and Ad26.COV2-S (Johnson & Johnson) 1.6 % (n = 2). Regarding the control, 34.4 % (n = 62) received AstraZeneca; 26.1 % (n = 47) Sinopharm; 16.7 % (n = 30) Pfizer; 11.7 % (n = 21) Sinovac; 6.7 % (n = 12) Sputnik; 3.3 % (n = 6) Johnson & Johnson and 1.2 % (n = 2) mRNA1273 (Moderna). COVID-19 infection decreased after vaccination from 32 (25.4 %) to 7 (5.6 %), and from 162 (81.0 %) to 85 (42.7 %) in RD patients and the control respectively. ICU admission decreased from (6.3 %) among RD patients and from (1.3 %) in control to 0 % after vaccination in both groups. In RD patients, body ache was the commonest reported vaccine adverse effect (44.4 %). Pain at the injection site was the commonest among control (77 %). ChAdOx1 (AstraZeneca) had the highest incidence of side effects, mRNA1273 (Moderna) showed the lowest.

          Conclusion

          COVID-19 vaccine was effective in decreasing infection and disease severity in RDs patients and control, with similar, mild adverse effects.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          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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            Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

            Stephen J. Thomas, Edson D. Moreira, Nicholas R.E. Kitchin … (2022)
            Background BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. Results BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. Conclusions Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728 .)
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              Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

              Victoria Furer, Tali Eviatar, Devy Zisman … (2021)
              Introduction Vaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited. Methods A multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose. Results Following vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients. Conclusion mRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Egypt Rheumatol
                Journal ID (iso-abbrev): Egypt Rheumatol
                Title: The Egyptian Rheumatologist
                Publisher: THE AUTHORS. Publishing services by ELSEVIER B.V. on behalf of The Egyptian Society of Rheumatic Diseases.
                ISSN (Print): 1110-1164
                ISSN (Electronic): 2090-2433
                Publication date PMC-release: 30 December 2022
                Publication date (Print): April 2023
                Publication date (Electronic): 30 December 2022
                Volume: 45
                Issue: 2
                Pages: 133-137
                Affiliations
                [a ]Internal Medicine Department, Rheumatology Division, Faculty of Medicine, Ain Shams University, Cairo, Egypt
                [b ]Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt
                Author notes
                [* ]Corresponding author.
                Article
                Publisher Item ID: S1110-1164(22)00131-4
                DOI: 10.1016/j.ejr.2022.12.003
                PMC ID: 9800813
                PubMed ID: 36597426
                SO-VID: 946598a8-4f2a-40af-a676-32bbf5654452
                Copyright © © 2022 THE AUTHORS
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 26 December 2022
                Date accepted : 26 December 2022
                Categories
                Subject: Article

                Keywords: rheumatic diseases,covid vaccine,adverse effects
                Data availability:
                Keywords: rheumatic diseases, covid vaccine, adverse effects

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