Cuba's COVID-19 Vaccine Approved for Children
Cuba began vaccinating children as young as 2 years of age on September 5, 2021, with a locally developed COVID-19 vaccine not recognized by the World Health Organization, reported Voice of America.
Cuba is administering the Soberana-2 COVID-19 vaccine, which was approved for this age group by local regulators on September 3, 2021.
On June 14, 2021, the first adolescents in the clinical trial were carried out at the Juan Manuel Márquez Pediatric Hospital, the Carlos J. Finlay polyclinic in the Marianao municipality, and the 5 de Septiembre polyclinic in the Playa municipality in the province of Havana.
All 350 children included in the trial received both doses of SOBERANA-02. In addition, all children in the subgroup 12 to 18 years old have already received the booster dose with SOBERANA-Plus.
This study's results showed that the SOBERANA-02 vaccine was safe for its administration in children and adolescents.
Based on the Phase I / II trial results in pediatric ages with SOBERANA-02, Cuba's Center for State Control of Medicines, Equipment, and Medical Devices was requested on August 27th to extend emergency use authorization for emergency use a population between 3 and 18 years of age.
Furthermore, the effect of the booster (3rd) vaccine dose with SOBERANA-Plus was summarized only for adolescents in Phase I of the trial. A significant increase in the values was detected after the 3rd vaccine dose with all the immunological variables.
The Soberana 02 vaccine has been in human clinical trials since October 30, 2020. Soberana 02 is produced by the Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, and the Pasteur Institute of Iran. The IFV was created in 1991.