4 de diciembre de 2021

Cuba starts testing COVID-19 vaccines candidate Soberana 02 in children

The Cuban Center for the Control of Drugs and Medical Equipment, CECMED, has approved the first clinical trial with a locally developed COVID-19 candidate vaccine on the pediatric population.

Soberana 02 vaccine candidate clinical trial on Cuban pediatric age starts on Monday 14,with the first phase to be applied to a group of teenagers aged from 12 and 18 years, at the Juan Manuel Marquez Pediatric Hospital, in Havana.

The clinical trial is aimed at evaluating the safety, immunogenicity and reacto-genicity of the Cuban vaccines Soberana 02 and Soberana Plus, produced by the Havana-based Finlay Vaccines Institute, in 28-day intervals.

The trial will include the children in the ages between 3 and 18 years divided into two groups, and starting by the ages of 12 to 18 years first, followed by a group of children between 3 and 11 years.

The approval of the trial is based on the increasing number of new COVID pediatric cases and also on the good results of the vaccines in terms of safety and immunogenicity.

CECMED director Olga Lidia Jacobo said that the approval of the clinical trial was quite a rigorous process that met all standards and requirements for the pediatric population.

(Edited from ACN)

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