Havana: The first 25 adolescents included in Cuba’s anti-Covid-19 clinical trial, Soberana-Pediatría, will receive the dose of the Soberana Plus vaccine candidate today and thus conclude the vaccination scheme, Prensa Latina publishes.
According to the project leaders, the group of volunteers between 12 and 18 years of age already has two injections of the Soberana 02 project, developed, like Soberana Plus- by the Finlay Vaccine Institute (IFV), the leading institution of the study.
The scheme administered in the pediatric analysis recently showed 91.2% efficacy against symptomatic disease (considered the main variable in the phase III study of Soberana 02).
The proposal also showed in its interim partial examination a 75.7 percent on the infection and 100 percent to prevent serious or severe cases and equal value before the deaths.
In the final analysis of efficacy on symptomatic disease for the two-dose Soberana 02 schedule, this variable increased from the 62 percent reported in the intermediate study, to 65.6 percent, Finlay experts explained.
In recent days, the administration of the second dose was completed to the 12 to 18-year-old age group of the second stage of Sovereign Pediatrics, as well as to the three to 11-year-olds from Phase I of the trial.
The selection of children under 12 was made after the safety of the first injection of Soberana 02 was verified in adolescents who had a medical follow-up of 24, 48, 72 hours and a week after being immunized.
Based on these results, a report was made to receive approval from the Center for State Control of Medicines, Equipment and Medical Devices, a regulatory authority, on the inclusion of the rest of the youngest and the sample with adolescents was expanded to 150.
The director of research at the Finlay Vaccine Institute, Dagmar García explained that they hope to have the first data from the research in pediatric ages by the end of August and the beginning of September, and then present the necessary documents in order to start vaccination in that population.
Cuban health authorities have highlighted on different occasions that immunization against Covid-19 in children and adolescents plays a fundamental role, as it could have a very positive effect in containing the progression of this disease.
Since the start of the pandemic in the country in March 2020, more than 72,000 infants have been confirmed with SARS-CoV-2, the pathogen that causes Covid-19.
The figures have increased in the last months of 2021 with an average of more than 1,500 cases per day in that age group.