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The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) decided on Tuesday to approve the authorization for emergency use of the Cuban vaccine Soberana Plus.
The vaccine, created by the Finlay Vaccine Institute (IFV), will extend its indication to the pediatric population convalescing from COVID-19 with two months or more of their medical discharge from the hospital or home.
Thus, the vaccine may be administered to all convalescents from two years of age, in accordance with the regulations and provisions in force, once it has been demonstrated that it meets the requirements in terms of quality, safety and immunogenicity for this population group.
This approval is based on the partial results of a Phase I/II clinical trial with Soberana Plus in children and adolescents convalescing from COVID-19, which showed that the administration of a single dose is safe, and provided elements of potential benefit in immunological terms against the potential risk of reinfection by SARS-CoV-2.
Cecmed conducted inspections of the sites where the clinical trial was conducted, verifying compliance with Good Clinical Practices during the execution of the trial.