The Finlay Vaccine Institute (IFV) announced on Wednesday at a press conference in Havana that a Phase I/II anti-COVID-19 clinical trial in pediatric populations could begin in the next few days, once it is authorized by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).

Vicente Vérez Bencomo, general director of the institution, explained that seven weeks ago they delivered to the Cuban regulatory authority the first version of the protocol with the Cuban vaccine candidates Soberana 02 and Soberana 01, and they are currently in the final phase of approval.

At first, it will start with the 12 to 18 year-old age group, to later include infants from three to 11 years old, but for now, there is no plan to reduce the age group because in that population segment, children receive several vaccines as part of the National Immunization Program and they will also be protected once the virus circulation decreases.

He also said that around 300 people from several municipalities of Havana will be included and the two-dose Soberana 02 and Soberana Plus scheme will be used.

The Cuban scientist said that a Phase I/II connected with effectiveness is being designed, with the aim of achieving the greatest amount of immunogenicity data, so as not to have to reach a Phase III of efficacy and include subjects with a placebo; ethically we do not consider that we have the right to use it in the pediatric population, he insisted.

Likewise, as part of the Phase II/III clinical trial with Soberana 01, in Cienfuegos, the IFV plans to include the 60 to 80 year-old population at first and then move down to the pediatric population.

Vérez Bencomo pointed out that by the end of this month they hope to have the authorization to start these investigations.

Regarding the Abdala vaccine candidate, Marta Ayala Avila, director of the Center for Genetic Engineering and Biotechnology, said that after the results accumulated during Phase I/II, the intervention and health intervention studies in groups and territories at risk, there are safety and immune response elements that allow to propose a protocol in pediatric ages.

Discussions are currently underway with specialists from the Pedro Kourí Tropical Medicine Institute, who will accompany the execution, and the first exchange meeting with CECMED is scheduled, to which the documentation will be delivered in the coming weeks and if authorized could start the trial at the end of June.

Source: Havana Tribune