Image: Finlay Vaccine Institute / Twitter.
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The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) decided today to approve the Authorization for Emergency Use (AUE) for the Cuban vaccine SOBERANA® 02, whose owner is the Finlay Vaccine Institute ( IFV), to expand its indication in the pediatric population aged between 2 to 18 years of age, in accordance with the provisions of current regulations and provisions, once it has been shown that it meets the requirements for quality, safety and immunogenicity for this population group.
First National Children’s Campaign against #COVID19 Worldwide.
Approves the @cubacecmed emergency use of the vaccine # Sovereign02 for children 2 to 18 years of age.
Moving hand in hand together in the fight against the epidemic. #CubaPorLaVida #ScienceCubana pic.twitter.com/kvx0XOSO0q– Finlay Vaccine Institute (@FinlayInstituto) September 4, 2021
This approval is supported on the basis of the results of the clinical trials carried out, which evaluated the safety and immunogenicity of this vaccine, applied with a two-dose schedule in the pediatric population (3 to 18 years) and compared with the results of a Similar trial with the same scheme, conducted in a population aged between 19 and 80 years, where the efficacy of this vaccine was demonstrated.
The results obtained in the study in the pediatric population were superior in all immunological variables with respect to the adult population aged 19 to 80 years and similar compared to the subgroup of young adults between 19 and 29 years. The safety profile evidenced was similar between the groups compared. Children from 2 years of age are included in this approval, considering information provided by the manufacturer that justified this inclusion.
CECMED carried out inspections of the clinical sites where the clinical trial was carried out, verifying compliance with Good Clinical Practices during the execution of the trial.
(With information from CECMED)
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