With the inclusion of the second group of volunteers between 3 and 11 years of age, after the first 25 adolescents between 12 and 18 years of age who received the first dose demonstrated their safety, the first clinical test in children and adolescents continues.

Yury Valdés Balbín, deputy director of the Finlay Vaccine Institute (IFV), explained at a press conference that 24, 48 and 72 hours and one week after immunization, the safety of the subjects was evaluated; and no serious adverse events were reported during this clinical test named Soberana-Pediatrics.

Based on these results, a report was prepared so that the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed) could approve the inclusion of the rest of the volunteers.

It also transpired that this Sunday Soberana 02 was applied to the 25 selected subjects; therefore, Phase I began with these children, who will also receive another dose of the immunogenic and one dose of Soberana Plus in the three-dose schedule, with an interval of 28 days.

This safety result of the adolescents between 12 and 18 years of age not only allows to start with the youngest ages, but also to extend the sample to another 150 children between 12 and 18 years of age, a process that will also start this week, added the researcher.

IFV specialists specified that this is an open study, because it will not use placebo, but all those involved will receive the vaccine candidates; at the same time it is adaptive, which implies making modifications without biases in the sample size or in other design elements.

It is also multicenter, as it will be carried out in several clinical sites. The first phase will be at the Juan Manuel Márquez Pediatric Hospital, and the second phase will include primary health care, with the inclusion of several polyclinics.

Soberana-Pediatrics involves 350 children and adolescents, 50 in Phase I and 300 in Phase II; stages that will be developed in a staggered and overlapping manner, complying with the strict ethical protocol, good clinical practices and with the informed consent of parents or legal guardians; and in the case of adolescents and young people, also with their assent.

Vaccinating children, adolescents and young people is essential in order to achieve high vaccination coverage and protect them from the high number of cases of SARS-COV-2 infection in the country.

Cuba dawned this June 24 with 1,604 active pediatric cases of the disease, including 118 children under one year of age. In addition to this, there is a high number of hospitalized patients under suspicion, and for 13 consecutive days more than 200 cases have been reported daily.

Source: Granma