Abstract

RODRIGUEZ-CHAVEZ, Suset et al. Safety of SOBERANAS® vaccines in children of workers of a BioCubaFarma institution. Vaccimonitor [online]. 2023, vol.32  Epub July 01, 2023. ISSN 1025-0298.

In a complex national and international epidemiological context of transmission and hospitalization by COVID-19 in the pediatric population, Cuba decided to carry out a massive vaccination campaign against this disease in children and adolescents. The aim of this work was to evaluate the safety of the heterologous scheme of two doses of SOBERANA®02 and one dose of SOBERANA®PLUS with 28 days between them, in children and adolescents who are sons of workers of the Centro Nacional de Biopreparados which belongs to BioCubaFarma, the Business Group of the Biotechnological and Pharmaceutical Industries of Cuba. The safety of the vaccines was evaluated through the identification and classification of adverse events by active and passive pharmacovigilance. A quantity of 237 children of both sexes was evaluated, and 200 were included (130 from 2 to 10 years, and 70 from 11 to 18 years). Of those included, 190 children (95%) received the complete vaccination schedule. A total of 121 adverse events were recorded, mostly due to passive pharmacovigilance, of mild intensity and A1 (related) causality. No related serious adverse events occurred. The SOBERANA®02 and SOBERANA®PLUS vaccines showed a very favorable safety profile during their administration to children and adolescents who are sons of workers at the Centro Nacional de Biopreparados.

Keywords : COVID-19; vaccines; child; safety.

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