دورية أكاديمية
أعرض في EDS

Vaccine-induced immune thrombotic thrombocytopenia after COVID-19 vaccination: Description of a series of 39 cases in Brazil.

التفاصيل البيبلوغرافية
العنوان: Vaccine-induced immune thrombotic thrombocytopenia after COVID-19 vaccination: Description of a series of 39 cases in Brazil.
المؤلفون: Mouta Nunes de Oliveira P; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil. Electronic address: Patricia.mouta@bio.fiocruz.br., Mendes-de-Almeida DP; Department of Hematology, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil; Division of Molecular Carcinogenesis, Research Center, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil; Division of Epidemiology, Department of Pediatrics, University of Minnesota, Minneapolis, United States of America., Bertollo Gomes Porto V; General Coordination of the National Immunization Program/National Immunization Program/ Brazilian Ministry of Health, Brazil., Crespo Cordeiro C; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Vitiello Teixeira G; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Saraiva Pedro R; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Roberto Gomes Takey P; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Kegele Lignani L; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Reis Xavier J; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Cardoso Doria da Gama V; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Amorim Filho L; Hemorio , Rio de Janeiro, Brazil., Emoingt Furtado B; AstraZeneca Brasil, Brazil., Santa Maria A; AstraZeneca Brasil, Brazil., Dahrug Barros T; General Coordination of the National Immunization Program/National Immunization Program/ Brazilian Ministry of Health, Brazil., Neves Waite Freitas L; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Dos Santos Pereira T; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Lima Abreu D; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Bernardes Ramos M; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil., Gabe C; Doctoral Program in Medicine at the Faculty of Medicine of the University of São Paulo, Brazil., Arnold D; McMaster Platelet Immunology Laboratory, Canada., William Smith J; McMaster Platelet Immunology Laboratory, Canada., Nazy I; McMaster Platelet Immunology Laboratory, Canada., Lourdes de Sousa Maia M; Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil.
مؤلفون مشاركون: Brazillian VITT Investigative Collaboration Group
المصدر: Vaccine [Vaccine] 2022 Aug 05; Vol. 40 (33), pp. 4788-4795. Date of Electronic Publication: 2022 Jun 16.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: COVID-19*/prevention & control , COVID-19 Vaccines*/adverse effects , Thrombocytopenia*/chemically induced , Thrombocytopenia*/epidemiology , Thrombosis*/chemically induced , Thrombosis*/epidemiology, Ad26COVS1 ; Adult ; BNT162 Vaccine ; Brazil/epidemiology ; ChAdOx1 nCoV-19 ; Female ; Humans ; Vaccination/adverse effects ; Vaccines/adverse effects
مستخلص: Objective: Describe a case series of vaccine-induced immune thrombotic thrombocytopenia (VITT) after COVID-19 vaccination in Brazil that included ChAdOx1 nCoV-19, Ad26.COV2.S and BNT162b2 vaccines, describing their clinical and laboratory characteristics.
Methodology: Descriptive case series study using Bio-Manguinhos/Fiocruz/AstraZeneca Brazil and National Immunization Program/Ministry of Health (NIP/MoH) data on COVID-19 AEFI surveillance. We obtained patient-level data from pharmacovigilance for AEFI surveillance and used both the NIP/MoH and Bio-Manguinhos/Fiocruz pharmacovigilance databases to create the study database. Thirty-nine cases of suspect VITT were included, 36 after ChAdOx1 nCoV-19, one after BNT162b2 and two after Ad26.COV2.S vaccine. All cases were based on meeting the Brighton Collaboration criteria for VITT. The primary outcomes were clinical and laboratory features, site of thrombosis, and anti-PF4 ELISA, when available.
Results: Thirty-nine cases met the criteria, 38 of which were classified as level 1 and one as level 3 according to Brighton Collaboration. Most cases had the central nervous system (CNS) as the main site of thrombosis (21/39) and happened after the vaccine first dose (34/39). The median age of the cases was 41 years old (23 to 86 yo). Most of the cases (61.5%) occurred in women. The median interval between vaccination and onset of symptoms was 8 days (0-37 days). The platelet count and D-dimer count had median values of 34,000/µL and 19,235 µg FEU/L, respectively. The ELISA anti-PF4 antibody was positive in 18 samples. The overall mortality rate was 51% and was higher in cases of CNS thrombosis with intracerebral bleeding.
Conclusion: Our case series shows that Brazilian VITT cases have similar clinical and laboratory profiles as demonstrated in the literature. Brazil has administered more than 300 million doses of COVID-19 vaccines (more than 110 million from ChAdOx1 nCoV-19). VITT seems to be a very rare but serious adverse event following COVID-19 immunization, especially adenoviral vector immunization.
Competing Interests: Declaration of Competing Interest Patricia Mouta Nunes de Oliveira ,Catherine Crespo Cordeiro, Debora Lima Abreu, Gabriellen Vitiello Teixeira, Janaina Reis Xavier, Letícia Kegele Lignani, Livia Neves Waite Freitas, Maria de Lourdes de Sousa Maia, Michael Bernardes Ramos, Patricia Mouta Nunes de Oliveira, Paulo Roberto Gomes Takey, Renata Saraiva Pedro, Tainá dos Santos Pereira, and Vitor Cardoso da Gama are employees of the Immunobiological Technology Institute/Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz), Marketing Authorization Holder of the covid-19 vaccine (recombinant)* in Brazil.  Bárbara Emoingt Furtado and André Santa Maria reports a relationship with AstraZeneca Brasil that includes: employment. employee of AstraZeneca Brasil , Marketing Authorization Holder of the covid-19 vaccine (recombinant)* in Brazil.  The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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فهرسة مساهمة: Keywords: COVID-19; Thrombocytopenia; Thrombosis; Vaccine-induced immune thrombotic thrombocytopenia
المشرفين على المادة: JT2NS6183B (Ad26COVS1)
0 (COVID-19 Vaccines)
0 (Vaccines)
B5S3K2V0G8 (ChAdOx1 nCoV-19)
N38TVC63NU (BNT162 Vaccine)
تواريخ الأحداث: Date Created: 20220702 Date Completed: 20220816 Latest Revision: 20221221
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC9212666
DOI: 10.1016/j.vaccine.2022.06.014
PMID: 35779962
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2022.06.014