HAVANA, Cuba – The head of the Centre for State Control of Medicines , Equipment and Medical Devices (CECMED), says a clinical trial on a COVID-19 vaccination for children is currently underway and is progressing satisfactorily.
According Dr Meiby de la Caridad Rodríguez González, the first anti-COVID-19 research in children and adolescents complied with a rigorous approval process seven weeks after the dossier was submitted to the regulatory authority. On June 14, during the application of the first dose, they had the first sanitary inspection by the CECMED.
The Soberana-Pediatrics clinical trial, includes in its first and second phase, children and adolescents between three and 18 years of age, healthy and of Cuban nationality.
Fifty volunteers were included in the first stage and 300 in the second.
The health authorities said the study would be carried out sequentially.
After the first week of immunisation, blood tests will be performed to determine the safety of the product, to request the approval of CECMED with a view to continue with the group from three to 11 years of age and to continue towards phase II with a greater number of adolescents.
The first stage of the research will be carried out at the Juan Manuel Márquez Pediatric Hospital and later the trial will be extended to the health areas of the municipalities of Playa, Marianao and La Lisa, said Rodríguez González. (CMC)
