The trial will involve 530 children aged 2 to 18, who will receive the single-dose scheme in two pediatric centers in the aforementioned territories.
Such decision responds to the culmination of Phase I and II clinical trials, with Cuban and international regulations, based on scientific evidence and good practices, said Dr. Meiby Vicente Gonzalez, from the Finlay Vaccine Institute, developer of the immunogen.
On September 23, the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), the national regulatory institution, approved the emergency use of the vaccine in patients aged 19 years and older who are convalescing from the disease.
Soberana Plus is administrated in a single-dose scheme, with elements of immunological benefit against the potential risk of reinfection by the new, more transmissible variants of the SARS-CoV-2 virus.
pgh/iff/acl/joe