Cuba Announces COVID-19 Clinical Trials in Children

Cuban Research Ethics Committee reviews clinical trial to determine the best formulation of Soberana 01 and Soberana 02 in pediatric population

Cuban News Agency

Dagmar Garcia Rivero, director of Research of the Finlay Vaccine Institute. (Photo: Irene Pérez / Cubadebate).

A clinical trial in pediatric ages could begin in April, Dagmar Garcia Rivero, director of Research of the Finlay Vaccine Institute (IFV) announced in Havana.

To demonstrate the effectiveness and impact of a vaccine candidate, it is necessary to achieve high vaccination coverage, so it is necessary to vaccinate pediatric populations, said the expert at a press conference with
authorities of that institution and the Group of Biotechnological and Pharmaceutical Industries of Cuba (BioCubaFarma).

However, she stressed that in order to advance clinical trials in children, a higher regulatory rigor is required, which is why it is necessary to carry out studies in adults first.

García Rivero explained that the clinical trial is under review by the Research Ethics Committee, to determine the best formulation of Soberana 01 and Soberana 02 in pediatric population.

She detailed that it will include participants between five and 18 years of age, with a first group between 12 and 18 years of age, and once this evaluation is completed, it will start with those between five and 12 years of age.

According to Vicente Vérez Bencomo, general director of the IFV, the study has the objective of guaranteeing the safety of infants in school stages, but those between zero and five years old will not be taken into account, because their immune systems are exposed to other vaccine loads intended for immunization in those periods of life.

Regarding people over 80 years of age, García Rivero pointed out, in a press conference, that this population group is not included in the clinical phase because the immune response capacity in an older adult is compromised due to age.

However, these people will be immunized once the efficacy of the vaccine candidates is demonstrated in clinical trials, the specialist clarified.

Cuba has three vaccine candidates developed by the IFV: Soberana 01, which plans to start phase II in the province of Cienfuegos; Soberana 02, which started phase III this Thursday in Havana, and Soberana 01 A, also known as Soberana Plus, to reactivate a pre-existing immune response, either in a convalescent individual or those who have had a vaccination scheme with another vaccine candidate.

Cuba also has Mambisa and Abdala, from the Center for Genetic Engineering and Biotechnology, the latter will reach Phase III clinical trials in March, in the eastern provinces of Santiago de Cuba and Guantanamo.

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