HAVANA, Cuba, Oct 20 (ACN) A second Cuban vaccine candidate will receive in the coming days the corresponding authorization from the Center for State Control of Drugs, Equipment and Medical Devices (CECMED by its Spanish acronym) for the beginning of its phase 1 clinical evaluation in healthy adults, after which it will be proposed application in the pediatric population.
This was made known by PhD. Vicente Verez, general director of the Finlay Vaccine Institute, belonging to BioCubaFarma Business Group, in an interview with Granma newspaper.
Soberana 2, name given to the new candidate, concluded all the required research phases in experimental animals and shares with its predecessor, Soberana 1, the fact that it is a molecular or subunit vaccine, as it is also called, whose antigen is a molecule that copies the molecule present in the virus, the specialist clarified.
This second Cuban vaccine is totally innovative, said Varez, as there are no similar ones among all those developed to combat the SARS-CoV-2 coronavirus in the world, and its particularity lies in being conjugated: the virus antigen is chemically bound to the tetanus toxoid.
He explained that this type of vaccine induces long-lasting immunity and the antibodies generated protect against the disease and prevent bacteria from colonizing the oropharynx of those vaccinated.
They have been used, above all, in the prevention of bacterial infectious diseases, and the first applied on a global scale was to combat Haemophilus Influenzae Type B, which causes childhood pneumonia and meningitis, the expert noted.
He also highlighted that both candidates are based on technological platforms for which there are precedents of vaccines in Cuba and in the world, aimed at other infectious diseases.
According to his statements, during the planned clinical trials of Soberana 2 it is expected to demonstrate its safety and achieve a powerful and durable protective immune response over time, just like Soberana 1, and to verify which of the immunological properties for which we have opted are confirmed in vaccinated subjects, he added.
Verez assured in the interview that the two doses of Soberana 1 had already been applied to the study participants and its safety was verified, with very few adverse effects, all slight; and that phase 1 of the study will end in the coming weeks with the analysis of the immune response of the participants.