Anti-COVID-19 vaccine trials with Soberana-Pediatría continues in Cuba

HAVANA, Cuba, Jul 1 (ACN) The Finlay Vaccine Institute reported today on Twitter that Cuba continues the anti-COVID-19 Soberana-Pediatrics clinical trial.

On Wednesday, the ward of the Juan Manuel Marquez Children’s Hospital in Havana, where the clinical trial is taking place, was full of laughter and colors as the minors participating in the study came for their follow-up consultation, as required 48 hours after getting the vaccine.

On Monday, about 25 children aged 3 to 11 received the first doses of Soberana 02 as volunteers for the Phase 1 trial of Soberana-Pediatría. Together with the 25 in the 12-to-18 age bracket already vaccinated, they make up the first sample of 50 at this stage.

On June 10, the Cuban regulatory authority—Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos—gave the clinical trials with children the go-ahead, taking into account the high number of COVID-19 cases nationwide, through a three-dose scheme, two of Soberana 02 and one of Soberana Plus, with a 28-day interval in between.

Soberana-Pediatría involves 350 children and adolescents in two scaled and overlapping phases—50 in Phase I and 300 in Phase II—and in full compliance with the current ethical protocol, good clinical practices, and the informed consent of their parents or legal guardians.