The Center for the State Control of Medicine, Equipment and Medical Devices decided to approve the Emergency Use Authorization for the Soberana Plus vaccine, created by the Finlay Institute of Vaccines to expand its indication in the pediatric population between the ages of 2 and 18 years old, according to the entity´s website.

Once it has been demonstrated that it complies with the established requirements in terms of quality, immunogenicity and safety, this condition was granted.

This approval is based on the results of the clinical trial which evaluated the safety and immunogenicity of this vaccine, applied as a third dose in a heterologous scheme that includes two previous doses of Soberana 02 in pediatric population (3 to 18 years old) compared with the results of a similar trial of the same scheme conducted in a population between 19 and 80 years old.

Previously, Abdala vaccine from the CIGB and Soberanas 02 and Plus from the Finlay Institute of Vaccines received this status for use in the adult population.

Also, the Emergency Use Authorization was granted to Soberana Plus to extend its indication in the population convalescing from Covid-19 in those over 19 years of age and to Soberana 02 in the pediatric population between 2 and 18 years of age.

Source: Gramma

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