Cuban researchers hope to begin clinical trials in April of a coronavirus vaccine candidate specifically designed for children between 5 and 18 years of age.
Dr. Dagmar García Rivero, director of research at the Finlay Vaccine Institute (IFV), affirmed this Thursday at a press conference that in order to achieve high immunization coverage to face the pandemic, “it is essential to vaccinate pediatric populations,” although she recalled that “advancing to clinical trials in children requires higher regulatory rigor.”
None of the COVID-19 vaccines already approved in other countries is currently designed for use in children, although there are multinational pharmaceutical companies that are already working on this type of research.
The IFV is the body responsible for the most advanced vaccine candidate in Cuba, Soberana 02, which has just received authorization to begin the third and final phase of clinical trials, in which its effectiveness will be tested on a large scale. If this stage is successful, the Cuban formula could become the first COVID-19 vaccine created in Latin America.
Studies of a children’s vaccine against coronavirus will be based on evaluating the best formulation of Soberana 02 and also Soberana 01, another of the formulas being developed by the IFV, for pediatric application.
According to García Rivero, the trial would involve minors between the ages of 12 and 18, and “once safety is covered” in that age group, it would be tested in the 5- to 12-year-old group.
The trial for the children’s vaccine is currently being reviewed by the Research Ethics Committee, the scientist added.
Hay una estrategia clínica, para la población pediátrica, a la cual está dirigida la plataforma más segura y probada en el desarrollo de #Vacunas contra la #COVID19. #CienciaCubana pic.twitter.com/tuvsD6IFYZ
— Instituto Finlay de Vacunas (@FinlayInstituto) March 4, 2021
Cuba is developing four COVID-19 vaccine candidates to which a fifth has just been added, specifically designed to avoid the risks of reinfection in people convalescing from the disease, named Soberana 01A or Soberana Plus and which can also be used as a reinforcement of other vaccines, according to IFV specialists.
Cuban authorities hope to be able to vaccinate the island’s entire population this year.
The island, which has reported 53,308 cases of coronavirus and 336 deaths since the beginning of the pandemic, has not acquired vaccines in the international market nor is it part of the Latin American countries that have joined the Covax Mechanism, created under the auspices of the World Health Organization (WHO) to promote equitable access to immunization for low- and middle-income nations.