HAVANA, June 28 (Xinhua) -- Cuban health authorities and scientists began on Monday expanding a clinical trial in children and adolescents of Soberana-02 and Soberana Plus, two of the five Cuban vaccine candidates against COVID-19.
After demonstrating safety in an initial group of 25 volunteers from 12 to 18 years old, the trial will expand to another 25 children between the ages of three and 11, with a first dose of Soberana-02.
Deputy Director of the Finlay Institute of Vaccines (IFV) Yuri Valdes explained that the safety results in the older age group allows the trial to advance to younger children and to expand the sample of adolescents, according to Havana's radio station Radio Reloj.
After controlling those vaccinated in the first 72 hours and a week after the immunization, "the safety of the subjects was evaluated and no serious adverse events were reported," he pointed out.
Based on these results, Valdes said, a report was prepared so that the Center for State Control of Medicines, Equipment and Medical Devices could approve the inclusion of the rest of the volunteers.
All of the 350 children and adolescents involved in the trial will receive two doses of Soberana-02 and a third of Soberana Plus, with an interval of 28 days between each immunization.