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 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

doi:10.3390/vaccines11101526

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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 language	English
Article number	1526
Journal	Vaccines
Volume	11
Issue number	10
DOIs	https://doi.org/10.3390/vaccines11101526
State	Published - 2023

Bibliographical note

Publisher Copyright:
© 2023 by the authors.

ASJC Scopus subject areas

Immunology
Pharmacology
Drug Discovery
Infectious Diseases
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.3390/vaccines11101526

Cite this

Le Corre, N., Abarca, K., Astudillo, P., Potin, M., López, S., Goldsack, M., Valenzuela, V., Schilling, A., Gaete, V., Rubio, L., Calvo, M., Twele, L., González, M., Fuentes, D., Gutiérrez, V., Reyes, F., Tapia, L. I., Villena, R., Retamal-Díaz, A., ... Kalergis, A. M. (2023). 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. Vaccines, 11(10), Article 1526. https://doi.org/10.3390/vaccines11101526

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

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{\textregistered} 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{\textregistered}; 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{\textregistered} was safe and well tolerated in children and adolescents, with different safety patterns according to age.",

keywords = "COVID-19 vaccines, CoronaVac, SARS-CoV-2, adolescents, children, inactivated virus vaccine, safety pattern",

author = "{Le Corre}, Nicole and Katia Abarca and Patricio Astudillo and Marcela Potin and Sof{\'i}a L{\'o}pez and Macarena Goldsack and Vania Valenzuela and Andrea Schilling and Victoria Gaete and Lilian Rubio and Mario Calvo and Loreto Twele and Marcela Gonz{\'a}lez and Daniela Fuentes and Valentina Guti{\'e}rrez and Felipe Reyes and Tapia, {Lorena I.} and Rodolfo Villena and Angello Retamal-D{\'i}az and Antonio C{\'a}rdenas and Eduardo Alarc{\'o}n-Bustamante and Xing Meng and Qianqian Xin and Gonz{\'a}lez-Aramundiz, {Jos{\'e} V.} and {\'A}lvarez-Figueroa, {Mar{\'i}a Javiera} and Gonz{\'a}lez, {Pablo A.} and Bueno, {Susan M.} and Soto, {Jorge A.} and Cecilia Perret and Kalergis, {Alexis M.}",

note = "Publisher Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = oct,

doi = "10.3390/vaccines11101526",

language = "English",

volume = "11",

journal = "Vaccines",

issn = "2076-393X",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "10",

}

Le Corre, N, Abarca, K, Astudillo, P, Potin, M, López, S, Goldsack, M, Valenzuela, V, Schilling, A, Gaete, V, Rubio, L, Calvo, M, Twele, L, González, M, Fuentes, D, Gutiérrez, V, Reyes, F, Tapia, LI, Villena, R, Retamal-Díaz, A, Cárdenas, A, Alarcón-Bustamante, E, Meng, X, Xin, Q, González-Aramundiz, JV, Álvarez-Figueroa, MJ, González, PA, Bueno, SM, Soto, JA, Perret, C & Kalergis, AM 2023, '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', Vaccines, vol. 11, no. 10, 1526. https://doi.org/10.3390/vaccines11101526

TY - JOUR

T1 - 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

AU - Le Corre, Nicole

AU - Abarca, Katia

AU - Astudillo, Patricio

AU - Potin, Marcela

AU - López, Sofía

AU - Goldsack, Macarena

AU - Valenzuela, Vania

AU - Schilling, Andrea

AU - Gaete, Victoria

AU - Rubio, Lilian

AU - Calvo, Mario

AU - Twele, Loreto

AU - González, Marcela

AU - Fuentes, Daniela

AU - Gutiérrez, Valentina

AU - Reyes, Felipe

AU - Tapia, Lorena I.

AU - Villena, Rodolfo

AU - Retamal-Díaz, Angello

AU - Cárdenas, Antonio

AU - Alarcón-Bustamante, Eduardo

AU - Meng, Xing

AU - Xin, Qianqian

AU - González-Aramundiz, José V.

AU - Álvarez-Figueroa, María Javiera

AU - González, Pablo A.

AU - Bueno, Susan M.

AU - Soto, Jorge A.

AU - Perret, Cecilia

AU - Kalergis, Alexis M.

PY - 2023/10

Y1 - 2023/10

N2 - 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.

AB - 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.

KW - COVID-19 vaccines

KW - CoronaVac

KW - SARS-CoV-2

KW - adolescents

KW - children

KW - inactivated virus vaccine

KW - safety pattern

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U2 - 10.3390/vaccines11101526

DO - 10.3390/vaccines11101526

M3 - Article

AN - SCOPUS:85175309816

SN - 2076-393X

VL - 11

JO - Vaccines

JF - Vaccines

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M1 - 1526

ER -