HAVANA, Cuba, Jan 27 (ACN) Cuban vaccine candidates Soberana 01 and 02, developed by the Finlay Vaccine Institute (IFV), are advancing their clinical trials at an accelerated pace in view of the global emergency decreed by the COVID-19 pandemic.
The institution's website refers that this result is possible due to the center's experience in the research of prophylactic vaccines and the review of clinical trial designs in specific anti-SARS-CoV-2 vaccines.
Soberana 01, the first Cuban drug against COVID-19, included five formulations that were studied in Phase I and concluded their analyses in December 2020, when the safety, low reactogenicity and adequate immunogenicity of the product were proven; hence, the candidate's Phase II/III is expected to begin in February.
In parallel, on January 16, a Phase I, open, adaptive and single-center study of Soberana 01 began at the Institute of Hematology and Immunology of Havana in convalescents of the disease, applied to subjects between 19 and 59 years of age with a mild clinical picture or who have been asymptomatic.
The publication notes that those convalescing from the pandemic constitute a non-negligible subpopulation that deserves to be studied, since many of them may not be adequately protected against a new contact with the virus.
As for Soberana 02, the most advanced Cuban candidate, it is currently in Phase II of clinical trials, after it started on December 17 in a health area of La Lisa municipality where more than 100 people have been vaccinated; and this January 18, Phase IIb began in another clinical site located in the 19 de Abril polyclinic in Plaza de la Revolución.
The study should include around 900 volunteers, who will receive vaccine and placebo, and by March, Phase III is expected to begin, with 150 thousand subjects distributed throughout different clinical sites in Havana.
According to the website, it is estimated that by April Soberana 02 will have emergency use in high-risk groups such as health personnel, airports and vulnerable people.
A clinical trial in children will begin in the coming months, taking into account the safety demonstrated by the product, the fact that the technology used has been used for more than 15 years for various vaccine candidates and constitutes a well-known platform with ample evidence of performance.
The technological platform of Soberana02 is the same method used for the production of Quimi-Hib®, a Cuban conjugate vaccine that has proven its efficacy in the infant population and has been part of the National Vaccination Program since 2004.
To achieve the immunization of the Cuban population, the IFV and the centers of the Group of the Biotechnological and Pharmaceutical Industries of Cuba (BioCubaFarma) have a common strategy that will allow expanding production capacities and creating reserves for commercialization, according to the publication.
Likewise, the Center for Molecular Immunology (CIM), the National Center for Biopreparations (BioCen) and other Cuban institutions are joining forces with the Finlay Vaccine Institute to produce the necessary doses.