Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.vaccine.2022.08.026 http://hdl.handle.net/11449/242222 |
Resumo: | Introduction: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18–60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and discussion: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events. |
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Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, BrazilAdverse eventsChadOx1-nCoV19COVID-19ImmunisationVaccine safetyIntroduction: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18–60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and discussion: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.Department of Pediatrics Oxford UniversityInstitute for Global Health Siena UniversityDepartment of Infectious Diseases Botucatu Medical School São Paulo State University (UNESP), São Paulo StateP95 Epidemiology & PharmacovigilanceDepartment of Biotechnology Faculty of Agronomical Sciences São Paulo State University (UNESP), São Paulo StateDivision of Informatics Botucatu Medical Hospital Botucatu Medical School São Paulo State University (UNESP), São Paulo StateBotucatu Health Department City of BotucatuDepartment of Clinical Medicine Botucatu Medical School São Paulo State University (UNESP), São Paulo StateInternational Vaccine Institute (IVI)Department of Infectious Diseases Botucatu Medical School São Paulo State University (UNESP), São Paulo StateDepartment of Biotechnology Faculty of Agronomical Sciences São Paulo State University (UNESP), São Paulo StateDivision of Informatics Botucatu Medical Hospital Botucatu Medical School São Paulo State University (UNESP), São Paulo StateDepartment of Clinical Medicine Botucatu Medical School São Paulo State University (UNESP), São Paulo StateOxford UniversitySiena UniversityUniversidade Estadual Paulista (UNESP)P95 Epidemiology & PharmacovigilanceCity of BotucatuInternational Vaccine Institute (IVI)Clemens, Sue Ann CostaFortaleza, Carlos Magno Castelo Branco [UNESP]Crowe, MadeleinePollard, AndrewTasca, Karen Ingrid [UNESP]Grotto, Rejane Maria Tommasini [UNESP]Martins, Marcelo Roberto [UNESP]Spadaro, André GaspariniBarretti, Pasqual [UNESP]Verstraeten, TomClemens, Ralf2023-03-02T11:51:55Z2023-03-02T11:51:55Z2022-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1016/j.vaccine.2022.08.026Vaccine.1873-25180264-410Xhttp://hdl.handle.net/11449/24222210.1016/j.vaccine.2022.08.0262-s2.0-85137026354Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengVaccineinfo:eu-repo/semantics/openAccess2024-08-14T17:22:25Zoai:repositorio.unesp.br:11449/242222Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-14T17:22:25Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
title |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
spellingShingle |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil Clemens, Sue Ann Costa Adverse events ChadOx1-nCoV19 COVID-19 Immunisation Vaccine safety |
title_short |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
title_full |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
title_fullStr |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
title_full_unstemmed |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
title_sort |
Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil |
author |
Clemens, Sue Ann Costa |
author_facet |
Clemens, Sue Ann Costa Fortaleza, Carlos Magno Castelo Branco [UNESP] Crowe, Madeleine Pollard, Andrew Tasca, Karen Ingrid [UNESP] Grotto, Rejane Maria Tommasini [UNESP] Martins, Marcelo Roberto [UNESP] Spadaro, André Gasparini Barretti, Pasqual [UNESP] Verstraeten, Tom Clemens, Ralf |
author_role |
author |
author2 |
Fortaleza, Carlos Magno Castelo Branco [UNESP] Crowe, Madeleine Pollard, Andrew Tasca, Karen Ingrid [UNESP] Grotto, Rejane Maria Tommasini [UNESP] Martins, Marcelo Roberto [UNESP] Spadaro, André Gasparini Barretti, Pasqual [UNESP] Verstraeten, Tom Clemens, Ralf |
author2_role |
author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Oxford University Siena University Universidade Estadual Paulista (UNESP) P95 Epidemiology & Pharmacovigilance City of Botucatu International Vaccine Institute (IVI) |
dc.contributor.author.fl_str_mv |
Clemens, Sue Ann Costa Fortaleza, Carlos Magno Castelo Branco [UNESP] Crowe, Madeleine Pollard, Andrew Tasca, Karen Ingrid [UNESP] Grotto, Rejane Maria Tommasini [UNESP] Martins, Marcelo Roberto [UNESP] Spadaro, André Gasparini Barretti, Pasqual [UNESP] Verstraeten, Tom Clemens, Ralf |
dc.subject.por.fl_str_mv |
Adverse events ChadOx1-nCoV19 COVID-19 Immunisation Vaccine safety |
topic |
Adverse events ChadOx1-nCoV19 COVID-19 Immunisation Vaccine safety |
description |
Introduction: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18–60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and discussion: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-01-01 2023-03-02T11:51:55Z 2023-03-02T11:51:55Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1016/j.vaccine.2022.08.026 Vaccine. 1873-2518 0264-410X http://hdl.handle.net/11449/242222 10.1016/j.vaccine.2022.08.026 2-s2.0-85137026354 |
url |
http://dx.doi.org/10.1016/j.vaccine.2022.08.026 http://hdl.handle.net/11449/242222 |
identifier_str_mv |
Vaccine. 1873-2518 0264-410X 10.1016/j.vaccine.2022.08.026 2-s2.0-85137026354 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
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Vaccine |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
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openAccess |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
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UNESP |
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Repositório Institucional da UNESP |
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Repositório Institucional da UNESP |
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Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
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1808128117484552192 |