Resumo

SAUREZ-MARTINEZ, Giselle et al. Intensive pharmacovigilance of SOBERANA®02 and Soberana®Plus vaccines in pediatric population at the Center for Molecular Immunology. Vaccimonitor [online]. 2023, vol.32  Epub 01-Jul-2023. ISSN 1025-0298.

The severe acute respiratory syndrome coronavirus 2 vaccines, SOBERANA®02 and SOBERANA®Plus, received authorization for emergency use by the Cuban regulatory authority; a massive vaccination campaign was immediately launched in the pediatric population, which led to an imminent mobilization of vaccination centers and surveillance of adverse events. The Molecular Immunology Center conducted an intensive pharmacovigilance study to evaluate compliance of the heterologous scheme with both vaccines, their safety, and the incidence of COVID-19 positive cases in children and adolescents after completing the immunization schedule. From September 15 to December 31, 2021, a total of 529 subjects between 2 and 18 years of age, of both sexes, without a history of infection by severe acute respiratory syndrome coronavirus type 2, from 35 municipalities and 12 Cuban provinces, who received SOBERANA®02 (two doses) and SOBERANA®Plus (one dose) vaccines, were included in the study. Surveillance for adverse events was performed up to 30 days after the last dose received. The national computer platform Higia Andariego was consulted to identify positive cases for severe acute respiratory syndrome coronavirus 2 up to 3 months after completing vaccination. According to the report, 98.5% of the participants completed the vaccination schedule and 6.6% of them reported some adverse event consistently related to vaccination. Local reactions (pain, erythema, inflammation) prevailed over systemic reactions (fatigue and fever), of light or moderate intensity. High compliance with the immunization schedule was achieved, with a favorable safety profile; subjects with a complete immunization schedule did not become ill with COVID-19.

Palavras-chave : COVID-19; SARS-CoV-2; immunization programs; mass vaccination; vaccines; observational study.

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