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
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2023
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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.