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

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dc.contributor.authorClemens, Sue Ann Costa
dc.contributor.authorFortaleza, Carlos Magno Castelo Branco [UNESP]
dc.contributor.authorCrowe, Madeleine
dc.contributor.authorPollard, Andrew
dc.contributor.authorTasca, Karen Ingrid [UNESP]
dc.contributor.authorGrotto, Rejane Maria Tommasini [UNESP]
dc.contributor.authorMartins, Marcelo Roberto [UNESP]
dc.contributor.authorSpadaro, André Gasparini
dc.contributor.authorBarretti, Pasqual [UNESP]
dc.contributor.authorVerstraeten, Tom
dc.contributor.authorClemens, Ralf
dc.contributor.institutionOxford University
dc.contributor.institutionSiena University
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionP95 Epidemiology & Pharmacovigilance
dc.contributor.institutionCity of Botucatu
dc.contributor.institutionInternational Vaccine Institute (IVI)
dc.date.accessioned2023-03-02T11:51:55Z
dc.date.available2023-03-02T11:51:55Z
dc.date.issued2022-01-01
dc.description.abstractIntroduction: 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.en
dc.description.affiliationDepartment of Pediatrics Oxford University
dc.description.affiliationInstitute for Global Health Siena University
dc.description.affiliationDepartment of Infectious Diseases Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.description.affiliationP95 Epidemiology & Pharmacovigilance
dc.description.affiliationDepartment of Biotechnology Faculty of Agronomical Sciences São Paulo State University (UNESP), São Paulo State
dc.description.affiliationDivision of Informatics Botucatu Medical Hospital Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.description.affiliationBotucatu Health Department City of Botucatu
dc.description.affiliationDepartment of Clinical Medicine Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.description.affiliationInternational Vaccine Institute (IVI)
dc.description.affiliationUnespDepartment of Infectious Diseases Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.description.affiliationUnespDepartment of Biotechnology Faculty of Agronomical Sciences São Paulo State University (UNESP), São Paulo State
dc.description.affiliationUnespDivision of Informatics Botucatu Medical Hospital Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.description.affiliationUnespDepartment of Clinical Medicine Botucatu Medical School São Paulo State University (UNESP), São Paulo State
dc.identifierhttp://dx.doi.org/10.1016/j.vaccine.2022.08.026
dc.identifier.citationVaccine.
dc.identifier.doi10.1016/j.vaccine.2022.08.026
dc.identifier.issn1873-2518
dc.identifier.issn0264-410X
dc.identifier.scopus2-s2.0-85137026354
dc.identifier.urihttp://hdl.handle.net/11449/242222
dc.language.isoeng
dc.relation.ispartofVaccine
dc.sourceScopus
dc.subjectAdverse events
dc.subjectChadOx1-nCoV19
dc.subjectCOVID-19
dc.subjectImmunisation
dc.subjectVaccine safety
dc.titleSafety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazilen
dc.typeArtigo

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