The study will include 592 children and adolescents between three and 18 years of age. The Center for State Control of Medicines, Equipment and Medical Devices (Cecmed), on July 2, approved the initiation of clinical trials in the pediatric age group of Cuba’s anti-COVID candidate vaccine Abdala, produced by the Center for Genetic Engineering and Biotechnology.
As reported on the Mesa Redonda television program, the trials will include 592 children and adolescents between three and 18 years of age. It will include volunteers and is entitled Ismaelillo, in honor of the poem that José Martí dedicated to his son.
This is a Phase I-II adaptive, randomized, double-blind, parallel-group, clinical investigation to evaluate, in apparently healthy Cuban children and adolescents, the safety and immunogenicity of a two-dose administration of the candidate vaccine to prevent COVID-19.
In order to participate in the study, an informed consent form must be signed by parents or legal guardians, as well as volunteers over 12 years of age.
The approval issued by Cecmed was based on a number of factors, specifically the currently alarming epidemiological situation, the significant increase of positive cases in the pediatric population, and information obtained in previous clinical trials with adult subjects.
Also reported was the news that Soberana 02 has been authorized by the Pasteur Institute of Iran for emergency use in the Islamic Republic.
According to a statement from Iranian Health Minister Dr. Said Nemeki, the vaccine will be marketed in the territory under the Pasteur name, within the framework of a collaboration agreement signed in January with the Finlay Vaccine Institute.
The authorization of Soberana 02 for emergency use in Iran was made on the basis of the product’s pharmaceutical development results, which demonstrated safety and immunogenicity in Phase I and II clinical trials conducted in Cuba, which showed 62% efficacy in the two-dose regimen.
(Taken from Granma)