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.authorNicole Le Corre
dc.contributor.authorKatia Abarca
dc.contributor.authorPatricio Astudillo
dc.contributor.authorMarcela Potin
dc.contributor.authorSofía López
dc.contributor.authorMacarena Goldsack
dc.contributor.authorVania Valenzuela
dc.contributor.authorAndrea Schilling
dc.contributor.authorVictoria Gaete
dc.contributor.authorLilian Rubio
dc.contributor.authorMario Calvo
dc.contributor.authorLoreto Twele
dc.contributor.authorMarcela González
dc.contributor.authorDaniela Fuentes
dc.contributor.authorValentina Gutiérrez
dc.contributor.authorFelipe Reyes
dc.contributor.authorLorena I. Tapia
dc.contributor.authorRodolfo Villena
dc.contributor.authorAngello Retamal-Díaz
dc.contributor.authorAntonio Cárdenas
dc.contributor.authorEduardo Alarcón-Bustamante
dc.contributor.authorXing Meng
dc.contributor.authorQianqian Xin
dc.contributor.authorJosé V. González-Aramundiz
dc.contributor.authorMaría Javiera Álvarez-Figueroa
dc.contributor.authorPablo A. González
dc.contributor.authorSusan M. Bueno
dc.contributor.authorJorge A. Soto
dc.contributor.authorCecilia Perret
dc.contributor.authorAlexis M. Kalergis
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.issn2076393X
dc.identifier.urihttps://repositorioabierto.uantof.cl/handle/uantof/582
dc.language.isoen
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceVaccines
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.volume11
organization.identifier.rorUniversidad de Antofagasta
uantof.identificator.departmentDepartamento Ciencias Médicas
uantof.identificator.facultyFacultad de Medicina y Odontología
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