Different Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac®) According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an Open-Label Study in Chile

dc.contributor.authorLe Corre, Nicole
dc.contributor.authorAbarca, Katia
dc.contributor.authorAstudillo, Patricio
dc.contributor.authorPotin, Marcela
dc.contributor.authorLópez, Sofía
dc.contributor.authorGoldsack, Macarena
dc.contributor.authorValenzuela, Vania
dc.contributor.authorSchilling, Andrea
dc.contributor.authorGaete, Victoria
dc.contributor.authorRubio, Lilian
dc.contributor.authorCalvo, Mario
dc.contributor.authorTwele, Loreto
dc.contributor.authorGonzález, Marcela
dc.contributor.authorFuentes, Daniela
dc.contributor.authorGutiérrez, Valentina
dc.contributor.authorReyes, Felipe
dc.contributor.authorTapia, Lorena I.
dc.contributor.authorVillena, Rodolfo
dc.contributor.authorRetamal-Díaz, Angello
dc.contributor.authorCárdenas, Antonio
dc.contributor.authorAlarcón-Bustamante, Eduardo
dc.contributor.authorMeng, Xing
dc.contributor.authorXin, Qianqian
dc.contributor.authorGonzález-Aramundiz, José V.
dc.contributor.authorÁlvarez-Figueroa, María Javiera
dc.contributor.authorGonzález, Pablo A.
dc.contributor.authorBueno, Susan M.
dc.contributor.authorSoto, Jorge A.
dc.contributor.authorPerret, Cecilia
dc.contributor.authorKalergis, Alexis M.
dc.date.accessioned2025-10-21T15:40:49Z
dc.date.available2025-10-21T15:40:49Z
dc.date.issued2023
dc.description.abstractDuring the COVID-19 pandemic, the importance of vaccinating children against SARS-CoV- 2 was rapidly established. This study describes the safety of CoronaVac® in children and adolescents between 3- and 17-years-old in a multicenter study in Chile with two vaccine doses in a 4-week interval. For all participants, immediate adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) were registered throughout the study. In the safety subgroup, AEs were recorded 28 days after each dose. COVID-19 surveillance was performed throughout the study. A total of 1139 individuals received the first and 1102 the second dose of CoronaVac®; 835 were in the safety subgroup. The first dose showed the highest number of AEs: up to 22.2% of participants reported any local and 17.1% systemic AE. AEs were more frequent in adolescents after the first dose, were transient, and mainly mild. Pain at the inoculation site was the most frequent AE for all ages. Fever was the most frequent systemic AE for 3–5 years old and headache in 6–17 years old. No SAEs or AESIs related to vaccination occurred. Most of the COVID-19 cases were mild and managed as outpatients. CoronaVac® was safe and well tolerated in children and adolescents, with different safety patterns according to age.
dc.description.sponsorshipSINOVAC Biotech, Beijing, China (PRO-nCOV-3002) and sponsored by the Pontificia Universidad Católica de Chile
dc.identifier.doi10.3390/vaccines11101526
dc.identifier.issn2076-393X
dc.identifier.urihttps://repositorioabierto.uantof.cl/handle/uantof/582
dc.language.isoen
dc.publisherMDPI
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceVaccines
dc.subjectCoronaVac®
dc.subjectSARS-CoV-2
dc.subjectCOVID-19 vaccines
dc.subjectinactivated virus vaccine
dc.subjectsafety pattern
dc.subjectchildren
dc.subjectadolescents
dc.titleDifferent Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac®) According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an Open-Label Study in Chile
dc.typeArticle
oaire.citation.issue10
oaire.citation.volume11
organization.identifier.rorhttps://ror.org/04eyc6d95
organization.legalNameUniversidad de Antofagasta
uantof.identificator.departmentDepartamento Ciencias Médicas
uantof.identificator.departmentDepartamento de Biotecnología
uantof.identificator.facultyFacultad de Medicina y Odontología
uantof.identificator.facultyFacultad de Ciencias del Mar y Recursos Biológicos
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