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      Development and exacerbation of autoimmune hemolytic anemia following COVID‐19 vaccination: A systematic review

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          Abstract

          Autoimmune hemolytic anemia (AIHA) is caused by the production of autoantibodies against RBCs. COVID‐19 vaccines can reduce the risk of severe disease, however, various adverse effects such as AIHA were observed following vaccination. This review aimed to assess the relationship of AIHA and COVID‐19 vaccination using the PRISMA guidelines. Among 18 cases included in this review, new post‐vaccination AIHA development was reported in 11 patients (7 women and 4 men) with a median age of 67.0 years. In 7 of 11 and 3 of 11 cases, the onset of symptoms occurred after first and second vaccine dose with median times of 7 and 14 days, respectively. In 1 of 11 cases, the AIHA occurred on Day 17 after booster vaccination. Ten of 11 and 1 of 11 AIHA patients received mRNA‐ and vector‐based vaccine, respectively. After vaccination, 9 of 11, 1 of 11, and 1 of 11 AIHA patients developed warm IgG, cold IgM, and mixed autoantibodies against RBCs, respectively. Significant AIHA exacerbation was reported in seven patients (four women and three men) with a median age of 73.0 years. In 4 of 7 and 2 of 7 exacerbated AIHA cases, the onset of symptoms occurred after first and second vaccine dose with median times of 7 and 3 days, respectively. In 1 of 7 exacerbated AIHA cases, the onset of symptoms was observed on Day 2 after booster vaccination. All exacerbated AIHA cases received mRNA‐based vaccines; 3 of 7 and 4 of 7 exacerbated AIHA cases developed IgG and IgM against RBCs, respectively. This review provides a comprehensive explanation regarding the AIHA development and exacerbation after COVID‐19 vaccination.

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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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            SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates

            Nikolaos Kyriakidis, Andrés López-Cortés, Eduardo González … (2021)
            The new SARS-CoV-2 virus is an RNA virus that belongs to the Coronaviridae family and causes COVID-19 disease. The newly sequenced virus appears to originate in China and rapidly spread throughout the world, becoming a pandemic that, until January 5th, 2021, has caused more than 1,866,000 deaths. Hence, laboratories worldwide are developing an effective vaccine against this disease, which will be essential to reduce morbidity and mortality. Currently, there more than 64 vaccine candidates, most of them aiming to induce neutralizing antibodies against the spike protein (S). These antibodies will prevent uptake through the human ACE-2 receptor, thereby limiting viral entrance. Different vaccine platforms are being used for vaccine development, each one presenting several advantages and disadvantages. Thus far, thirteen vaccine candidates are being tested in Phase 3 clinical trials; therefore, it is closer to receiving approval or authorization for large-scale immunizations.
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              Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting

              Ulrich Jäger, Wilma Barcellini, Catherine M. Broome … (2019)
              Autoimmune hemolytic anemias (AIHAs) are rare and heterogeneous disorders characterized by the destruction of red blood cells through warm or cold antibodies. There is currently no licensed treatment for AIHA. Due to the paucity of clinical trials, recommendations on diagnosis and therapy have often been based on expert opinions and some national guidelines. Here we report the recommendations of the First International Consensus Group, who met with the aim to review currently available data and to provide standardized diagnostic criteria and therapeutic approaches as well as an overview of novel therapies. Exact diagnostic workup is important because symptoms, course of disease, and therapeutic management relate to the type of antibody involved. Monospecific direct antiglobulin test is considered mandatory in the diagnostic workup, and any causes of secondary AIHA have to be diagnosed. Corticosteroids remain first-line therapy for warm-AIHA, while the addition of rituximab should be considered early in severe cases and if no prompt response to steroids is achieved. Rituximab with or without bendamustine should be used in the first line for patients with cold agglutinin disease requiring therapy. We identified a need to establish an international AIHA network. Future recommendations should be based on prospective clinical trials whenever possible.
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                Author and article information

                Contributors
                Abdollah Jafarzadeh:
                ORCID: https://orcid.org/0000-0002-8180-0602
                jafarzadeh14@yahoo.com
                Seyed Mohammad Javad Mortazavi: mortazavismj@gmail.com
                Journal
                Journal ID (nlm-ta): Int J Lab Hematol
                Journal ID (iso-abbrev): Int J Lab Hematol
                Journal ID (doi): 10.1111/(ISSN)1751-553X
                Journal ID (publisher-id): IJLH
                Title: International Journal of Laboratory Hematology
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 1751-5521
                ISSN (Electronic): 1751-553X
                Publication date (Electronic): 08 October 2022
                Publication date PMC-release: 08 October 2022
                Electronic Location Identifier: 10.1111/ijlh.13978
                Affiliations
                [ 1 ] Department of Immunology, School of Medicine Kerman University of Medical Sciences Kerman Iran
                [ 2 ] Molecular Medicine Research Center Research Institute of Basic Medical Sciences, Rafsanjan University of Medical Sciences Rafsanjan Iran
                [ 3 ] Department of Immunology, School of Medicine Rafsanjan University of Medical Sciences Rafsanjan Iran
                [ 4 ] Student Research Committee, School of Medicine Kerman University of Medical Sciences Kerman Iran
                [ 5 ] Department of Microbiology, School of Medicine Kerman University of Medical Sciences Kerman Iran
                [ 6 ] Immunology of Infectious Diseases Research Center Research Institute of Basic Medical Sciences, Rafsanjan University of Medical Sciences Rafsanjan Iran
                [ 7 ] Department of Haematology and Laboratory Sciences, School of Para‐Medicine Kerman University of Medical Sciences Kerman Iran
                [ 8 ] Department of Medical Physics and Engineering Shiraz University of Medical Sciences Shiraz Iran
                Author notes
                [*] [* ] Correspondence

                Abdollah Jafarzadeh, Department of Immunology, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.

                Email: jafarzadeh14@ 123456yahoo.com

                Seyed Mohammad Javad Mortazavi, Department of Medical Physics and Engineering, Shiraz University of Medical Sciences, Shiraz, Iran.

                Email: mortazavismj@ 123456gmail.com

                Author information
                https://orcid.org/0000-0002-8180-0602
                Article
                Publisher ID: IJLH13978
                DOI: 10.1111/ijlh.13978
                PMC ID: 9874780
                PubMed ID: 36208056
                SO-VID: 7b75449b-5c08-4f73-8f5d-cbd05a759b54
                Copyright © © 2022 John Wiley & Sons Ltd.
                License:

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                Date received : 17 March 2022
                Date accepted : 14 September 2022
                Page count
                Figures: 1, Tables: 3, Pages: 11, Words: 6665
                Categories
                Subject: Review
                Subject: Reviews
                Custom metadata
                source-schema-version-number 2.0
                edited-state corrected-proof
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.3 mode:remove_FC converted:25.01.2023

                ScienceOpen disciplines: Hematology
                Keywords: autoimmune hemolytic anemia,covid‐19,sars‐cov‐2,vaccination
                Data availability:
                ScienceOpen disciplines: Hematology
                Keywords: autoimmune hemolytic anemia, covid‐19, sars‐cov‐2, vaccination

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