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.

        · resumen en Español     · texto en Español     · Español ( pdf )