The proven safety of Soberana02 and SoberanaPlus has made it possible to take this step, among the first in the world, said the president on his Twitter account, where he thanked Cuban scientists for this achievement.
Cuba’s State Center for the Control of Medicines and Medical Devices (Cecmed) approved the implementation of the anti-Covid-19 clinical trial in the pediatric population with the vaccine candidates Soberana 02 and Soberana Plus on Thursday night.
This is a Phase I-II, open, adaptive and multicenter study to evaluate safety, reactogenicity and immunogenicity, with a scheme of two doses of Soberana 02 and one of Soberana Plus, both developed by the Finlay Vaccines Institute.
The approval is based on the current epidemiological context, the considerable increase in the number of 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 of clinical trials,’ said Cecmed.
This stage will be carried out at the Juan Manuel Marquez Pediatric Hospital, in Havana, with patients from three to 18 years, who will be part of a sample of 350 volunteers and must present an informed consent to participate in the study, as well as that of their parents or legal guardians.