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

Nicole Le Corre, Katia Abarca, Patricio Astudillo, Marcela Potin, Sofía López, Macarena Goldsack, Vania Valenzuela, Andrea Schilling, 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 CárdenasEduardo 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

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article number1526
JournalVaccines
Volume11
Issue number10
DOIs
Publication statusPublished - Oct 2023

Keywords

  • adolescents
  • children
  • CoronaVac
  • COVID-19 vaccines
  • inactivated virus vaccine
  • safety pattern
  • SARS-CoV-2

ASJC Scopus subject areas

  • Immunology
  • Pharmacology
  • Drug Discovery
  • Infectious Diseases
  • Pharmacology (medical)

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