CAMAGÜEY.-After completing the Ismaelillo clinical trial in this city and analyzing the results, the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) decided to approve the Authorization for Emergency Use of the Cuban vaccine Abdala for pediatric population in ages between 2 and 11 years. Last week the regulatory entity had authorized the use in the segment between 12 and 18 years.

The report states that with a scheme of three doses of 0.5 mL and an interval of 14 days between each application, in accordance with the provisions of current regulations and provisions, it has been shown that "it meets the requirements of quality, safety and efficacy for this population group. Clinical trials evaluated the safety and immunogenicity of this vaccine ”.

More than 500 children, aged between 3 and 18 years, received a three-dose schedule and with a similar trial developed in a population aged between 19 and 29 years, they showed similar results, which ensures the success of the vaccine.

In addition, CECMED directly accompanied the study and carried out inspections of the nine Camagüey's vaccine sites that hosted the trial, verifying compliance with good clinical practices during its execution.

Children from 2 years of age are included in this approval, considering information provided by the manufacturer that justified this inclusion.

The report also recalls that the Abdala 50 ug vaccine showed in a phase III trial an efficacy of 92.28% in the prevention of symptomatic COVID-19 and 100% in avoiding severe forms and death.

Translated by Linet Acuña Quilez