CIGB Cuba

Havana, July 1 (RHC)-- The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) authorized the Center for Genetic Engineering and Biotechnology Thursday to start the Pediatric Clinical Trial with the vaccine candidate 'Abdala.'

An adaptive, randomized, double-blind, parallel-group, double-blind, Phase I/II clinical trial will be conducted to evaluate the safety and immunogenicity in apparently healthy Cuban children and adolescents with two dose levels.

The trial will include 592 children and adolescents between 3 and 18 years of age who will voluntarily participate, with the signature of the Informed Consent by parents or legal guardians.

Additionally, the Informed Consent form must be signed by participants older than 12 years of age, residing in health areas of urban zones of the head municipality of Camagüey.

This Pediatric Clinical Trial with Abdala is named after  'Ismaelillo', recalling José Martí's singular poem to his son.

After applying the three-dose formulation, the Abdala vaccine candidate has an efficacy of 92.28 percent, which places it well above the World Health Organization's requirement for declaring an anti-Covid-19 vaccine as such, which must have at least 50 percent efficacy.