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      Autoimmune phenomena following SARS-CoV-2 vaccination

      brief-report
      Author(s): a , b , 1 , a , 1 , a , c , d , a , e , a , a , c , *
      Publication date (Electronic):
      Journal: International Immunopharmacology
      Publisher: Elsevier B.V.
      Keywords: COVID-19, SARS-CoV-2, Vaccines, Autoimmunity, BNT162b2, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, COVID-19, coronavirus disease 2019, CRP, C-reactive protein, ANA: antinuclear antibody, RF, rheumatoid factor, ACPA, anti-citrullinated protein antibody, ED, emergency department, FMF, familial Mediterranean fever, ESR, erythrocyte sedimentation rate, AF, atrial fibrillation, ECG, electrocardiography, TTE, transthoracic echocardiogram, NSAIDs, non-steroidal anti-inflammatory drugs, CPK, creatinine phosphokinase, LDH, lactate dehydrogenase, HIV, human immunodeficiency virus, CT, computed tomography, NLRP3, NLR pyrin domain containing 3, TLR, toll-like receptor, MHC, Major histocompatibility complex

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          Abstract

          Vaccines represent an attractive possible solution to the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Widespread vaccine distribution has yet to occur in most countries, partially due to public concerns regarding possible side effects. While studies indicate the vaccine is exceptionally safe, rare systemic side effects remain possible. In Israel, where a large percentage of the population has been rapidly vaccinated, such adverse events may be more apparent. We report a series of patients presenting with de-novo or flares of existing autoimmune conditions associated with the Pfizer BNT162b2 mRNA SARS-CoV-2 vaccine. All patients were assessed in our tertiary care center in Israel and had no history of previous SARS-COV-2 infection. We observed that while immune phenomena may occur following vaccination, they usually follow a mild course and require modest therapy. We briefly expound on the theoretical background of vaccine related autoimmunity and explore future research prospects.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J Thomas, Nicholas R.E. Kitchin … (2022)
          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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            BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

            Noa Dagan, Noam Barda, Eldad Kepten … (2021)
            Abstract Background As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel’s largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine. Methods All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19–related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan–Meier estimator. Results Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions. Conclusions This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19–related outcomes, a finding consistent with that of the randomized trial.
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              COVID-19 vaccines: modes of immune activation and future challenges

              John Teijaro, Donna Farber (2021)
              The new vaccines against SARS-CoV-2 are novel in terms of specificity, their wide dissemination across the global population and the inclusion of newly licensed mRNA platforms. We discuss here how the approved vaccines trigger innate immunity to promote durable immunological memory and consider the future implications of protecting populations with these vaccines.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Int Immunopharmacol
                Journal ID (iso-abbrev): Int Immunopharmacol
                Title: International Immunopharmacology
                Publisher: Elsevier B.V.
                ISSN (Print): 1567-5769
                ISSN (Electronic): 1878-1705
                Publication date PMC-release: 10 July 2021
                Publication date (Print): October 2021
                Publication date (Electronic): 10 July 2021
                Volume: 99
                Page: 107970
                Affiliations
                [a ]Department of Medicine, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel
                [b ]Gastroenterology Unit, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel
                [c ]Rheumatology Unit, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel
                [d ]Department of Ophthalmology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel
                [e ]Allergy and Clinical Immunology Unit, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel
                Author notes
                [* ]Corresponding author.at: Department of Medicine and the Rheumatology Unit, Hadassah-Hebrew University Medical Center, POB 12000, Jerusalem 91120, Israel.
                [1]

                The first two authors contributed equally.

                Article
                Publisher Item ID: S1567-5769(21)00606-8 Publisher ID: 107970
                DOI: 10.1016/j.intimp.2021.107970
                PMC ID: 8270741
                PubMed ID: 34280851
                SO-VID: fce44957-06f1-43e4-810f-47a91289ddd8
                Copyright statement: © 2021 Elsevier B.V. All rights reserved.
                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.

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                Subject: Article

                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: covid-19,sars-cov-2,vaccines,autoimmunity,bnt162b2,sars-cov-2, severe acute respiratory syndrome coronavirus 2,covid-19, coronavirus disease 2019,crp, c-reactive protein, ana: antinuclear antibody,rf, rheumatoid factor,acpa, anti-citrullinated protein antibody,ed, emergency department,fmf, familial mediterranean fever,esr, erythrocyte sedimentation rate,af, atrial fibrillation,ecg, electrocardiography,tte, transthoracic echocardiogram,nsaids, non-steroidal anti-inflammatory drugs,cpk, creatinine phosphokinase,ldh, lactate dehydrogenase,hiv, human immunodeficiency virus,ct, computed tomography,nlrp3, nlr pyrin domain containing 3,tlr, toll-like receptor,mhc, major histocompatibility complex
                Data availability:
                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: covid-19, sars-cov-2, vaccines, autoimmunity, bnt162b2, sars-cov-2, severe acute respiratory syndrome coronavirus 2, covid-19, coronavirus disease 2019, crp, c-reactive protein, ana: antinuclear antibody, rf, rheumatoid factor, acpa, anti-citrullinated protein antibody, ed, emergency department, fmf, familial mediterranean fever, esr, erythrocyte sedimentation rate, af, atrial fibrillation, ecg, electrocardiography, tte, transthoracic echocardiogram, nsaids, non-steroidal anti-inflammatory drugs, cpk, creatinine phosphokinase, ldh, lactate dehydrogenase, hiv, human immunodeficiency virus, ct, computed tomography, nlrp3, nlr pyrin domain containing 3, tlr, toll-like receptor, mhc, major histocompatibility complex

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