The Soberana and Abdala vaccines have moved ahead to Phase III testing on volunteers in Havana and cities in the east of Cuba. The Center for the Control of Medicines and Medical Devices (CECMED) approved the Phase III clinical trials of the two COVID vaccines.
The Soberana 02 COVID vaccine will be tested on 150,000 front-line staff volunteers from Havana. Testing of the Abdala, also beginning Phase III, has been moved ahead because of the feasibility of production and the need to immunize the entire population. With the help of 48,000 volunteers between 19 and 80 years old are taking part in a randomized double-blind placebo control study in the cities of Santiago, Guantanamo and Bayamo.
The results of the Soberana trial will complement the data obtained from the Phase III testing and evaluate the reduction of the incidence and dispersion of the epidemic in the population.
The clinical trials began today in several institutions certified as vaccination centers.
Likewise, through a bilateral agreement with Venezuela, President Nicolas Maduro announced a shipment of 30,000 doses of Soberana 02 and 30,000 of Abdala from Cuba. The shipment will arrive in the first week of April. These vaccines will be used on volunteers in that nation.
The Cuban Strategy
These actions are part of Cuba’s strategy to defeat the coronavirus and provide its population and those from other countries the tools to defeat the pandemic.
Dr. Gerardo Guillén, director of the Center for Genetic Engineering and Biotechnology (CIGB) said that the center has been contributing products that are used today as COVID treatment protocols, including 13 research projects, for prevention, diagnosis, therapeutics for positive and severe cases, and vaccines.
“The vaccine candidate Mambisa was the second to enter a clinical study and the phase I results were very positive. The Mambisa has had very good results and we are redirecting it to other niches of indications for the product,” said Dr. Guillén.
The Mambisa vaccine candidate demonstrated its efficacy as a booster dose and in convalescents.