The State Center for the Control of Medicines and Medical Devices of Cuba (CECMED) approved this phase I/II study last week. It will take place at the Juan Manuel Márquez Pediatric Hospital in the capital, and it will be sequential, open, adaptive, and multicenter in children between the ages of three and 18.
The 350 people in pediatric ages who will participate in the trial will be divided into two groups: the first one integrated by adolescents from 12 to 18 and the second one from three to 11.
The objectives of this stage are to evaluate the safety, reactogenicity, and immunogenicity of the prophylactic vaccine candidates designed by the Finlay Vaccine Institute (IFV), separated by 28-day intervals, a scheme already applied to the adult population.
Since the beginning of the pandemic on the island, a total of 20,849 infants have been infected with SARS-CoV-2, the cause of Covid-19.
In this context, vaccination would play a fundamental role, since it could have a very positive effect on the containment of the progression of this disease”, CECMED said.