First clinical trial against COVID-19 in the pediatric population to start in Cuba
The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved the start of the first clinical trial in pediatrical population in Cuba with a vaccine candidate against COVID-19 developed by the Finlay Vaccine Institute (IFV).
The announcement, released on the official CECMED website, adds that the approved study is a phase I / II, sequential, open, adaptive and multicenter trial, the purposes of which are to evaluate the safety, reactogenicity and immunogenicity of prophylactic vaccine candidates.
They are FINLAY-FR-2 (Sovereign 02), applied in two doses and a third of FINLAY-FR-1A (Sovereign Plus), applied in periods of 28 days. This scheme will be applied between the ages of 3 to 18 years, divided into two groups.
From 12 to 18 and between 3 and eleven years old. CECMED approval is based on the safety and immunogenicity results shown by vaccine candidates during phase I and phase II clinical trials. already supplied to thousands of people, adds the information.
In this regard, the Director of CECMED, MSc. Olga Lidia Jacobo Casanueva referred to the evaluation and approval process of this clinical trial, which has been very rigorous, complying with the requirements demanded in pediatric populations, she assured.
She finally pointed out the need to protect the country's children population from the complex epidemiological situation, and that they can, in a short time, return to normalcy, attend schools, play, walk and do daily activities.