Clinical trials of Cuba’s anti-COVID-19 vaccine Abdala, successfully administered to millions of adults, indicate that it is safe and effective in pediatric age groups
Author: National news staff | informacion@granma.cu
february 17, 2022 10:02:47
Cuba’s anti-COVID-19 vaccine Abdala - developed by the Center for Genetic Engineering and Biotechnology (CIGB) and successfully administered to millions of adults - is safe and effective in pediatric age groups, as no serious adverse side effects were reported during clinical trials, dubbed Ismaelillo and Meñique, the scientific institution announced on Twitter.
The CIGB reported that the majority of side effects observed were local and mild, mainly at the injection site.
In the case of the Meñique trial - the study conducted in Havana to evaluate the safety and immunogenicity of the drug in subjects between three and 18 years of age - results confirm that Abdala is highly immunogenic in this population group, and as the announcement explains, "induces high titers of anti-RBD IgG antibodies, which inhibit the binding of RBD to the ACE-2 receptor and neutralize SARS-COV-2."
For its part, the Ismaelillo study was conducted with more than 500 children from three to 18 years of age, over a period of almost three months in the provincial capital city of Camagüey, with encouraging results in terms of safety and immunogenicity, demonstrating that more than 80% of the adverse events reported were mild, while other indicators were comparable to the data obtained in adults.
Based on the results of these rigorous studies, Cuba’s Center for State Control of Drugs, Equipment and Medical Devices approved the Abdala anti-COVID vaccine for emergency use in the pediatric population between two and 18 years of age.