Havana, June 11 - The president of Cuba, Miguel Díaz- Canel, described today as transcendental the approval by the health authorities of the start of the anti-COVID-19 clinical trial in the pediatric population, with vaccine candidates from the island.
The demonstrated security of Soberana02 and SoberanaPlus have made it possible to take this step, among the first in the world, said the president on his Twitter account, where he thanked the scientists for this achievement.
The State Center for the Control of Medicines and Medical Devices of Cuba (Cecmed) approved the day before the execution of the anti-COVID-19 clinical trial in the pediatric population with the vaccine candidates Soberana 02 and Soberana Plus.
It is a Phase I-II, open, adaptive and multicenter study to evaluate safety, reactogenicity and immunogenicity, with a schedule of two doses of Soberana 02 and one of Soberna Plus, both developed by the Finlay Institute of Vaccines.
The approval is based on the current epidemiological context, the considerable increase in positive cases in the pediatric population, and on the safety and immunogenicity results of the vaccine candidates, as part of the phase I and phase II clinical trials, Cecmedreported.
This stage will be carried out at the Juan Manuel Márquez Pediatric Hospital, in Havana, with patients between 3 and 18years old who will make up a sample of 350 volunteers, who must present an informed consent to participate in the study; as well as that of their parents or legal guardians. (Text and photo: PL)