17 de enero de 2022

Cuba advances on vaccination trial in children under 12

The first group of children between 3 and 11 years old included in Cuba’s COVID-19 clinical trial called ‘Soberana-Pediatria’ (‘Soberana-Pedriatics’) is receiving their first dose of Soberana 02 on Monday 28.

According to authorities of the Finlay Institute of Vaccines (IFV), developer of the project, the volunteers were selected after the initial injection of Soberana 02 in 25 adolescents in the 12-18 age range proved safe.

The IFV assistant director, Yury Valdes, explained that this last group was followed up on 24, 48 and 72 hours after being vaccinated.

A report was prepared based on the results in order to receive the approval of the Center for State Control of Medicine, Equipment and Medical Devices, the regulatory authority, on the inclusion of the rest of volunteers, and the sample based on teenagers will be expanded up to 150.

The clinical study will see the participation of 350 subjects ranging from ages 3 to 18, which will be administered a series of two doses of Soberana 02 and one of Soberana Plus, separated in an interval of 28 days between each application.

Said scheme using both IFV products was already tried on the adult population, and the Institute recently confirmed 62 percent efficacy with two doses of Soberana 02.

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