Once expected approval by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) is granted, in the first days of March phase III clinical trials will begin of Cuba’s Abdala (CIGB-66) and Soberana 02 candidate vaccines against COVID-19, which have proven to be safe and effective in producing a powerful immune response to the virus.
During a press tour of the facilities where the antigens of these vaccines are produced, Doctor in Sciences Eduardo Martínez Díaz, president of Cuba’s Biotechnology and Pharmaceutical Industries Enterprise Group (BioCubaFarma), reported that industrial-scale production of these injectables continues, alongside the studies.
Regarding the Abdala candidate, specifically, President of the Republic Miguel Díaz-Canel Bermúdez, commented on Twitter, "Large scale production is already underway at the prestigious AICA Laboratory. Batches ready for phase III clinical trials, in Santiago and Guantanamo, starting in March. Encouraging news, but no cause for carelessness."
Dr. Vicente Vérez Bencomo, general director of the Finlay Vaccine Institute, indicated that some 44,000 volunteers will participate in phase III trails of the Soberana 02 candidate, while a community intervention trial will be conducted including more than 1,000,000 subjects.
In both cases, he added, the goal is to determine the efficacy of the vaccine in preventing infection, an issue which, to date, has not beeen analyzed with any of the candidates, plus this second trial will allow for the immunization of more people.
Master of Science Eduardo Ojito Magaz, director of the Molecular Immunology Center (CIM), institution responsible for manufacturing the antigen that serves as raw material for the Soberana vaccines, stated that the more than 300,000 doses of Soberana 02 needed for the trial are ready; while work is currently focused on producing those required for the second study.
Marta Ayala Avila, Party Political Bureau member and general director of the Center for Genetic Engineering and Biotechnology (CIGB), noted that this institution, which is now producing antigens for the Abdala and Mambisa candidates (CIGB-669), has more than 30 years of experience in productions of this nature, specifically with the use of the yeast pichia pastoris, which is used in the manufacture of protein subunit vaccines.
