Havana, June 12 (ACN) 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.
The clinical trial is aimed at evaluating the safety, immunogenicity, and reactogenicity 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 children between the ages of 3 and 18 years divided into two groups and starting with 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.
Abel González Alayón
Chief-Editor Language Department
Cuban News Agency
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