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
Journal
Vaccines
ISSN
2076-393X
Date Issued
2023
Author(s)
Nicole Le Corre
Katia Abarca
Patricio Astudillo
Marcela Potin
Sofía López
Macarena Goldsack
Vania Valenzuela
Victoria Gaete
Lilian Rubio
Mario Calvo
Loreto Twele
Marcela González
Daniela Fuentes
Valentina Gutiérrez
Felipe Reyes
Lorena I. Tapia
Rodolfo Villena
Angello Retamal-Díaz
Antonio Cárdenas
Eduardo Alarcón-Bustamante
Xing Meng
Qianqian Xin
José V. González-Aramundiz
María Javiera Álvarez-Figueroa
Pablo A. González
Susan M. Bueno
Jorge A. Soto
Cecilia Perret
Alexis M. Kalergis
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:p>During 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.</jats:p>
Subjects
adolescents
;
children
;
coronavac<sup>®</sup>
;
covid-19 vaccines
;
inactivated virus vaccine
;
safety pattern
;
sars-cov-2
;
coronavac
;
immunoglobulin g
;
immunoglobulin m
;
immunosuppressive agent
;
adolescent
;
allergy
;
antigenicity
;
article
;
cellular immunity
;
child
;
chile
;
cohort analysis
;
controlled clinical trial
;
controlled study
;
coronavirus disease 2019
;
disease surveillance
;
double blind procedure
;
drug safety
;
fatigue
;
female
;
fever
;
follow up
;
headache
;
human
;
humoral immunity
;
injection site pain
;
major clinical study
;
male
;
multicenter study
;
myalgia
;
nutritional status
;
open study
;
preschool child
;
severe acute respiratory syndrome coronavirus 2
;
skin redness
;
transfusion
;
vaccination
;
vaccine immunogenicity
;
vaccine reactogenicity