HAVANA, Cuba, Aug 9 (ACN) With the administration of one dose of the Cuban anti-COVID-19 vaccine candidate Soberana Plus, the first 25 adolescents included in the study concluded today the Soberana-Pediatría clinical trial.
The group included volunteers between the ages of 12 and 18 who received two shots of Soberana 02, also developed by the Finlay Vaccine Institute (IFV), the study's lead institution. According to research, the scheme used in the said pediatric analyses proved to be 91.2 % effective against the symptomatic disease, the main variable of the Soberana 02 Phase III study.
Likewise, the proposal also showed 75.7 % effectiveness to prevent infection and 100 % to prevent serious complications or death.
Finlay specialists explained that the selection of children under 12 years of age was made after the safety of the first shot of Soberana 02 was proven in adolescents, who were monitored 24, 48, 72 hours and one week after being immunized.
Once these results were recorded, the product was submitted for approval to the Center for State Control of Medicines, Equipment and Medical Devices, the regulatory authority, in order to extend the sample to 150 minors.
Dagmar García, research director of the Finlay Vaccine Institute, explained that they expect to have the first data from the research in pediatric ages in late August and early September and then take care of the required formalities to start the vaccination process with the said population.