Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil

Detalhes bibliográficos
Autor(a) principal: Clemens, Sue Ann Costa
Data de Publicação: 2022
Outros Autores: 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
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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spelling 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
dc.relation.none.fl_str_mv Vaccine
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
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instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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