Evaluating the safety profile of the CoronaVac in adult and older adult populations: A phase IV prospective observational study in Brazil
Rattachement africain : br. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
This 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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Evaluating the safety profile of the CoronaVac in adult and older adult populations: A phase IV prospective observational study in Brazil
- Date Crossref
- 25/02/2025
- Éditeur
- Public Library of Science (PLoS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Instituto Butantan pays non établi dans la noticeStructure de recherche
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Universidade de Ribeirão Preto pays non établi dans la noticeUniversité ou école supérieure
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo pays non établi dans la noticeÉtablissement de santé
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Clinical Trials and Pharmacovigilance Center pays non établi dans la noticeÉtablissement de santé
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Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado pays non établi dans la noticeUniversité ou école supérieure
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Centro de Saúde Escola da Faculdade de Medicina de Botucatu-Unesp pays non établi dans la noticeInstitution
Instituto Butantan, Universidade de Ribeirão Preto et Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, avec 3 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.