Safety, immunogenicity and efficacy of SOBERANA® 02 and SOBERANA ® Plus vaccines in pediatric population
Keywords:
vaccine, SARS-CoV-2, COVID-19, SOBERANA, pediatricAbstract
Introduction. SOBERANA® 02 and SOBERANA® Plus vaccines in their heterologous combination have demonstrated their safety, immunogenicity and efficacy in adults, while a single dose of SOBERANA® Plus is sufficient for the protection of COVID-19´s convalescents.
Objective: To evaluate the safety, immunogenicity and efficacy of SOBERANA® 02 and SOBERANA® Plus vaccines in pediatric population.
Methods: Two phase clinical studies were designed to evaluate the safety and immunogenicity of the SOBERANA® 02 and SOBERANA® Plus vaccines in healthy children and convalescents from COVID-19.
Results: The application of the heterologous combination of these vaccines proved to be safe in the pediatric population. Mild, short-term local adverse events predominated and no serious events related to vaccination were reported. Immunogenicity demonstrated that 96.2% of participants seroconverted after two doses of SOBERANA® 02 and 100% after the third dose with SOBERANA® Plus. The induction of neutralizing antibodies was demonstrated for the different variants: alpha, delta, beta and omicron; and duration of response up to 5-7 months after completion of the heterologous three-dose regimen. Additionally, non-inferiority was demonstrated for the viral neutralization variable among children and young adults. The study of the cellular response in children vaccinated with the heterologous three-dose schedule showed the induction of a powerful response of effector and memory T cells, specific to SARS-CoV-2, higher than that observed in individuals exposed to natural infection.
Conclusions: The heterologous scheme of two doses of SOBERANA® 02 and a third dose with SOBERANA® Plus was safe, immunogenic and effective in children from (3 to 18) years of age.
Downloads
Published
How to Cite
Issue
Section
License
The journal Anales de la Academia de Ciencias de Cuba protects copyright, and operates with a Creative Commons License 4.0 (Creative Commons Attribution-NonCommercial License 4.0). By publishing in it, authors allow themselves to copy, reproduce, distribute, publicly communicate their work and generate derivative works, as long as the original author is cited and acknowledged. They do not allow, however, the use of the original work for commercial or lucrative purposes.
The authors authorize the publication of their writings, retaining the authorship rights, and assigning and transferring to the magazine all the rights protected by the intellectual property laws that govern in Cuba, which imply editing to disseminate the work.
Authors may establish additional agreements for the non-exclusive distribution of the version of the work published in the journal (for example, placing it in an institutional repository or publishing it in a book), with recognition of having been first published in this journal.
To learn more, see https://creativecommons.org
