Evaluating the safety profile of the CoronaVac in adult and older adult populations: A phase IV prospective observational study in Brazil

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Autor(es): dc.contributorInstituto Butantan-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.creatorInfante, Vanessa-
Autor(es): dc.creatorde Camargo Teixeira Cintra, Monica Akissue-
Autor(es): dc.creatorFernandes, Eder Gatti-
Autor(es): dc.creatorLoch, Ana Paula-
Autor(es): dc.creatorRagiotto, Lucas-
Autor(es): dc.creatorBraga, Patrícia Emília-
Autor(es): dc.creatorda Graça Salomão, Maria-
Autor(es): dc.creatorLucchesi, Maria Beatriz Bastos-
Autor(es): dc.creatorde Oliveira, Mayra Martho Moura-
Autor(es): dc.creatorGattás, Vera Lúcia-
Autor(es): dc.creatorda Silva, Anderson Soares-
Autor(es): dc.creatorBoas, Paulo José Fortes Villas-
Autor(es): dc.creatorLopes, Marta Heloisa-
Autor(es): dc.creatorMoreira, José-
Autor(es): dc.creatorBoulos, Fernanda Castro-
Autor(es): dc.creatorViscondi, Juliana Yukari Kodaira-
Autor(es): dc.creatorOliveira, Luciana Campanher-
Autor(es): dc.creatorKoike, Marcelo Eiji-
Autor(es): dc.creatorBriques, Wellington-
Data de aceite: dc.date.accessioned2025-08-21T17:55:12Z-
Data de disponibilização: dc.date.available2025-08-21T17:55:12Z-
Data de envio: dc.date.issued2025-04-29-
Data de envio: dc.date.issued2025-02-25-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1371/journal.pgph.0004069-
Fonte completa do material: dc.identifierhttps://hdl.handle.net/11449/301849-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/301849-
Descrição: dc.descriptionThis Phase IV prospective observational study aimed to evaluate the frequency of solicited and unsolicited adverse reactions within seven days following the administration of each dose of CoronaVac (14-day interval) by age group (18–59 years and ≥60 years). Participants (n = 538; 487 adults and 51 older adults) were enrolled from three public health centers in São Paulo, Brazil from May 2021 to January 2022. The study involved a two-dose vaccination regimen administered 14 days apart. Solicited and unsolicited adverse reactions (ARs) were assessed within seven days after each dose, and medically attended adverse events following immunization (AEFI) were monitored for 42 days. Safety data were collected through participant diary cards, telephone follow-ups, and on-site visits. Among adults, the most frequently reported local AR after the first and second doses was pain (256 [52.6%] and 129 [29.5%], respectively), while the most common systemic AR was headache (158 [34.5%] and 51 [11.6%], respectively). Most local and systemic solicited ARs were of Grade 1 or 2 severity, with ARs being more prevalent in adults following the first dose. One serious adverse event related to the vaccine was reported in adults, with no fatalities. Nine adult participants experienced adverse events of special interest, including five cases of COVID-19. These findings support the overall safety profile of CoronaVac in adults and older adult individuals, with adverse events being generally mild and self-limited.-
Descrição: dc.descriptionFundação Butantan-
Descrição: dc.descriptionClinical Trials and Pharmacovigilance Center Instituto Butantan-
Descrição: dc.descriptionCentro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado-
Descrição: dc.descriptionCentro de Saúde Escola da Faculdade de Medicina de Botucatu—Unesp-
Descrição: dc.descriptionCentro de Referência de Imunobiológicos Especiais Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIE-HCFMUSP)-
Descrição: dc.descriptionInstituto Butantan-
Descrição: dc.descriptionCentro de Saúde Escola da Faculdade de Medicina de Botucatu—Unesp-
Idioma: dc.languageen-
Relação: dc.relationPLOS Global Public Health-
???dc.source???: dc.sourceScopus-
Título: dc.titleEvaluating the safety profile of the CoronaVac in adult and older adult populations: A phase IV prospective observational study in Brazil-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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