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CECMED supervises pediatric clinical trial in Cuban province

CECMED supervises pediatric clinical trial in Cuban province

Camagüey, Cuba, Aug 12 (Prensa Latina) Supervision by the State Center for Control of Medicines, Equipment and Medical Devices (CECMED) is very important today in the development of pediatric clinical trials against Covid-19 in this Cuban region.
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The third most populated city in Cuba has been developing, since July 15, this important project, called Ismaelillo, which began in a first phase with adolescents aged 12-18, although in recent weeks it was extended to children born since 2018, in a process that in the first two phases benefits some 600 children with the Abdala vaccine.

Specialists who first monitored the quality of the vaccination process underlined the extraction of blood from volunteer children, who previously had the approval of parents for the study.

In statements to local media, the CECMED inspector of good clinical practices, Diadelis Remirez, noted that in addition to the control of operations and the process in general, the experts’ visits will be extended to the pharmacies that provide services in this process, in addition to the Empresa Comercializadora de Medicamentos in the province.

Sonia Resik, senior researcher of studies with Abdala in Cuba, assured just before the start of the trial that ‘with Ismaelillo the safety and immunogenicity issues of the drug in children and adolescents are evaluated, final results will arrive in October.’

Ismaelillo, authorized by CECMED, gains importance in this territory, 540 kilometers from Havana, with Abdala, a vaccine that has already shown an efficacy level of 92.28 percent.

jg/lcr/mem/fam

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