From April, Cuba will produce vaccine candidates against SARS-CoV-2 mutations

HAVANA, Cuba, Apr 16 (ACN) 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 on Thursday Dr. Miladys Limonta Fernandez, coordinator of vaccine candidate development projects of the institution.

She pointed out that Abdala will start next April 19 with the application of the third dose in the Phase III clinical study, which is being carried out in eastern Cuba and will conclude on May 1.

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 submitting its dossier to the regulatory authority, with a view to using it in COVID-19 convalescents and as a booster dose for other vaccines, she said.

The specialist explained that at the beginning, the process of obtaining the RBD fragment for these drugs included 46 types of variants in different host systems, according to the capacity of the CIGB, in accordance with the different platforms of its products, whether in bacteria, yeast, mammalian cells, plants as bioreactors and chemical synthesis.

From the broad spectrum of platforms, and taking into account the entire product development strategy, the process began with the analytical scale stage, i.e., the experimental design, which continued with the bench scale where the specifications and the non-clinical and clinical phase I and II studies are established.

Regarding the non-clinical studies, which are carried out before submitting the dossier to the regulatory authority and including the first volunteer, she said that there are the studies for the demonstration of the concept and pharmacology, single and repeated dose toxicology, repeated dose toxicity in primates, local tolerance in rats and reproduction toxicity also in rats.

The process then reaches the production scale with Phase III clinical studies, registration and subsequent commercialization.

Limonta Fernandez pointed out that in obtaining the biological materials for the development of the specific assays of the vaccine candidates, the CIGB had the support of the Molecular Immunology Center in the development of proteins and antibodies were created at the CIGB of Sancti Spiritus for the techniques to be used in the determination of host contaminants.

In addition, the Immunoassay Center efficiently evaluated the samples for clinical studies and the Civil Defense Research Center, based on the isolation of the virus, was able to provide a technique for studies on the neutralization capacity of candidates against SARS-CoV-2.