Cuba Approves Emergency Use of Soberana 02 in Children, Adolescents

With the approval of the emergency sanitary use of the Soberana 02 vaccine in the pediatric population, Cuba will become the first country to carry out a national childhood immunization campaign against COVID-19.

The Center for State Control of Medicines, Equipment and Medical Devices (CECMED), the Cuban regulatory authority, announced on its website the authorization to extend the use of the immunogen of the Finlay Vaccine Institute in the population aged between two and 18 years, “following the regulations and provisions in force, once it has been demonstrated that it meets the requirements in terms of quality, safety, and immunogenicity for this population group.”

CECMED argued that the approval is based on the results of the clinical trials carried out in a two-dose scheme in a pediatric population from three to 18 years of age, and compared with similar tests in a population segment between 19 and 80 years of age; from which it was concluded that in the infant age range all the immunological variables were superior concerning the adult population and similar compared with the subgroup of young adults between 19 and 29 years of age.

The inclusion of infants from two years of age considered information provided by the manufacturer, CECMED explained.