Resumen

REYES-ZAMORA, Mary Carmen et al. Intervention study with SOBERANA^® in the workers of the Centro Nacional de Biopreparados. Vaccimonitor [online]. 2022, vol.31, n.2, pp. 43-53.  Epub 01-Ago-2022. ISSN 1025-0298.

The results of an intervention study performanced at the Centro Nacional de Biopreparados, a company of BioCubaFarma, are presented. The research was promoted by the Finlay Vaccine Institute, with the aim of evaluating the direct and indirect effects of vaccination against SARS-CoV-2, with a heterologous 2P + 1 scheme: two doses of SOBERANA®02 plus one dose of SOBERANA®Plus with 28 days between them; in population cohorts at risk of infection, disease and spread of the epidemic. A quantity of 1,007 subjects were evaluated and 924 were initially included. Of these, 97.62% received the complete vaccination schedule. Subsequently, 21 convalescents of COVID-19 with at least two months of clinical discharge were included, who received a single dose of SOBERANA®Plus. The safety of the vaccine was evaluated by identifying and classifying adverse events by active and passive pharmacovigilance. A total of 482 adverse events were recorded, mostly due to passive pharmacovigilance, mild intensity and A1 causality (related). No related serious adverse events occurred. IgG anti SARS-CoV-2 was quantified in 100 individuals, and 68% had a response greater than or equal to 50 IU/mL, these subjects being nine years younger than those with a lower response. Up to three months after the intervention, 64 vaccinated people were diagnosed with COVID-19 and none of them were seriously ill or died. A very favorable safety profile of SOBERANA® and indications of effectiveness in preventing severe forms and mortality from COVID-19 were evidenced.

Palabras clave : COVID-19; vaccines; safety.