The Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) of Cuba announced this Friday the authorization for emergency use to inoculate the island’s pediatric population with the Sovereign 02 vaccine, created by its scientists.
The director of the Cuban regulatory authority Cecmed, Olga Lidia Jacobo, explained to state television that in order to approve the application of Sovereign 02 in children and adolescents, a “very rigorous” process of evaluation of this formula developed by the state Institute has been followed. Finlay Vaccines (IFV).
After the evaluation carried out by Cecmed of the vaccine, it has been shown that it has an “adequate profile” and the “immunogenicity” required for its application in the pediatric population, as specified by the specialist. “There is solid information on its use in this population and it represents a historic moment in our country,” added Jacobo.
An essay with 350 children
Sovereign 02 is a subunit conjugate vaccine that combines virus antigen and tetanus toxoid to stimulate the immune system response. The Finlay Vaccine Institute has carried out the clinical trial “Soberana Pediatría” with 350 children from Havana between 3 and 18 years of age.
In this test, the scheme included two doses of Soberana 02 at an interval of 28 days plus one of Soberana Plus on day 56 and demonstrated 91.2% efficacy against symptomatic disease in its phase III analysis, according to the scientific institution. .
On August 20, Cecmed authorized the emergency use of Soberana 02 and Soberana Plus -designed as a reinforcement of natural immunity or induced by other vaccines-, which allowed them to become vaccines against the coronavirus, like Abdala , and with them there are three Cuban developed and approved vaccines that have the authorization for emergency use.
Cuba began this Friday to vaccinate its pediatric population (from 2 to 18 years old) with its own formulas against the coronavirus, a step prior to resuming on Monday 6 of the 2020-2021 school year in a virtual way.
The director of Science and Innovation of the Ministry of Public Health (Minsap), Ileana Morales, has said that the pediatric vaccination campaign should end on November 15 and will be “gradual” and “intensive.” It is part of a government strategy that sets the goal of reaching November with 92.6% of the population immunized, according to a note from the Presidency.
Almost four million people – of the 11.2 million inhabitants that Cuba has – already have three doses of these formulas against covid-19, according to the island’s health authorities. More than 70,000 children and adolescents have been infected in Cuba with the SARS-Cov-2 coronavirus since the beginning of the pandemic in March 2020.