Havana, Apr 16 - The Center for Genetic Engineering and Biotechnology (CIGB) will be able to produce vaccine candidates against original strains of SARS-CoV-2 and mutants starting this month, announced Doctor of Science Miladys Limonta Fernández, coordinator of development projects for vaccination candidates of the institution.
During his speech on the radio and television program Mesa Redonda, he pointed out that Abdala will begin on April 19 with the application of the third dose in the Phase III clinical study, which is carried out in eastern Cuba and will conclude on May 1st.
Meanwhile, Mambisa, one of the five nasal vaccine candidates in the world, concluded the first phase with good safety results and is in the process of presenting its file to the regulatory authority, with a view to using it in convalescents from COVID-19 and as a booster dose for other vaccines, he said.
The specialist explained that initially the process of obtaining the RBD fragment for these drugs had 46 types of variants in various host systems, according to the capacity of the CIGB, according to the different platforms of its products, whether in bacteria, yeast, mammalian cells, plants as bioreactors and chemical synthesis.
Starting from the wide spectrum of platforms, and taking into account the entire development strategy of a product, the process began with the analytical scale stage, that is, the experimental design, which continued with the bench scale where the specifications are established. and Phase I and II non-clinical and clinical studies.
Regarding the non-clinical studies, which are carried out before the presentation of the file to the regulatory authority and include the first volunteer, he expressed that there are studies for the demonstration of the concept and pharmacology, of toxicology at single doses and repeated doses, the of repeated dose toxicity in primates, of local tolerance in rats and of reproductive toxicity also in rats.
Then the process reaches the production scale Phase III clinical trials, registration and the subsequent marketing.
Limonta Fernández highlighted that in obtaining the biological materials for the development of the specific tests of the vaccine candidates, the CIGB had the support of the Center for Molecular Immunology in the development of proteins and the CIGB of Sancti Spíritus created antibodies to the techniques to be used in the determination of host contaminants.
In addition, the Immunoassay Center efficiently evaluated the samples from the clinical studies and the Civil Defense Research Center, based on the isolation of the virus, was able to have a technique to study the neutralization capacity of the candidates against SARS-CoV-2. (ACN)