HAVANA, Cuba, Sep 24 (ACN) The Center for State Control of Medicines, Equipment and Medical Devices (CECMED by its Spanish acronym) approved the authorization for emergency use of the Cuban vaccine Soberana Plus, developed by the Finlay Institute of Vaccines.
This authorization makes it possible to extend its indication to the COVID-19 convalescent population over 19 years of age, two months or more after their medical discharge from the hospital or at home, according to the Cuban regulatory authority's statement.
It has been obtained once it has been demonstrated that the immunogen fulfills the requirements in terms of quality, safety and immunogenicity for that population group.
Such approval is supported based on the results of the clinical trials carried out, which evaluated the safety and immunogenicity of the vaccine, applied in a single-dose scheme with elements of benefit in immunological terms against the potential risk of reinfection by the new, more transmissible variants of SARS-CoV-2.
Soberana Plus achieved its authorization on August 20 its authorization for emergency use as part of the two-dose Soberana 02 plus Plus heterologous scheme in the adult population, and on September 3 it was extended to infants and adolescents.