CAMAGÜEY.- Three specialists from the Center for the Control of Medicines, Equipment and Medical Devices (Cecmed) inspect the clinical practices carried out in the clinical trial with the Abdala vaccine in pediatric populations. Cecmed, as the drug regulatory authority in the country, evaluates and authorizes clinical trials.
As explained by Dr. C. Diadellis Remírez Figueredo, Cecmed's senior researcher at the head of the evaluation team, after the clinical trials are approved, they are inspected and this has been done in several provinces. "We know about the experience that Camagüey has in trials in these populations and the skills of the professionals to carry out the study."
The researcher added that the objective is to verify good clinical practices during the process. To do this, they review from the selection of volunteers, the previous blood tests, the application of the immunogen, the different services such as laboratory, pharmacy, as well as the databases where the results of the test are collected digitally. They will visit the vaccination centers of the nine polyclinics in the city of Camagüey and the Medicines Marketing Company, and they will inspect the transfer of the drug and blood samples, and all associated documentation.
"The main thing is the regulatory follow-up and leaving recommendations to get a better idea of what happens in the real conditions of the study," she emphasized.
Ismaelillo is the second anti-COVID-19 clinical trial in pediatric populations that has been approved in the country. The first was Sovereign Pediatrics in Havana, both in times of a high incidence of the disease at these ages.
The team is completed by two other Cecmed specialists who will announce the results next Friday.
The adolescents participating in phases I and II of the 12 to 18-year-old group have already received their second dose, while the first among those from 3 to 11 were immunized with the initial one last week. In the next few days, in correspondence with the results of this audit, phase II should begin in the smallest and Abadala should reach another 200, with which the approximately 600 planned will already be under study.
Translated by Linet Acuña Quilez