Cuba took another important step in the protection of children, Diaz-Canel asserts

HAVANA, Cuba, Jun 11 (ACN) Cuban president Miguel Diaz-Canel said today on Twitter that the country took another transcendental step in the protection of children, on the approval on Thursday of the first clinical trial in the pediatric population with the anti-COVID-19 vaccine candidates Soberana 02 and Soberana Plus.

The president highlighted that this Phase I/II study was approved by the national regulatory authority, the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED by its Spanish acronym).

He added in another message that the proven safety of Soberana02 and SoberanaPlus has made it possible to take this step, among the first in the world, and thanked the country's scientists for developing these drugs.

On Thursday afternoon, a CECMED press release published on its website made official the approval of the clinical trial for the pediatric population, with vaccine candidates against COVID-19 from the Finlay Vaccine Institute.

This is a phase I/II, sequential, open-label, adaptive and multicenter study, which aims to evaluate the safety, reactogenicity and immunogenicity of FINLAY-FR-2 (Soberana 02), applied in two doses, and of one dose of FINLAY-FR-1A (Soberana Plus); separated by 28-day intervals.

This scheme, according to the document, is the same as the one applied to the adult population, and will be carried out in the ages between three and 18 years old, divided into two groups, starting with adolescents from 12 to 18 years old, followed by the group of children from 3 to 11 years old.