Start of clinical trial in convalescent pediatric population of COVID-19 approved

Havana, Cuba, Sep 29.- The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) announced today the authorization to start a clinical trial with Soberana Plus for children convalescing from COVID-19.

It is necessary to carry out the clinical trial in the pediatric population and not only grant the authorization for emergency use, so the research will cover about 530 infants from the capital and the province of Cienfuegos, said Olga Lidia Jacobo Casanueva, director of CECMED.

Through the safety and immunogenicity results of Soberana Plus in adults, this step is carried out that will protect the entire convalescent population from a possible reinfection with more contagious variants of the virus, she pointed out in the radio-television program Mesa Redonda.

During her intervention, she ratified the rigor present in clinical trials in children based on the scientific evidence of their promoters, the inspections of the clinical sites and the experience that is had in the production of vaccines in the country.

CECMED is awaiting the results of the clinical trial of the Abdala vaccine, which is being carried out in the province of Camagüey, to also determine its authorization for emergency use in the pediatric population.

Likewise, the institution evaluates the Soberana Centro clinical trial in the province of Cienfuegos, which includes the vaccine candidate Soberana 01, in addition, its specialists analyze all the batches of vaccines that are applied in the country.

On September 23, the Cuban regulatory authority granted the authorization of emergency use of Soberana Plus for a convalescent population over 19 years of age. (ACN)

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