Phase III clinical trials of Cuba’s Soberana 02 vaccine for COVID-19 from the Finlay Vaccine Institute will begin after receiving approval from Cuba’s regulatory authority, the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).
Soberana 02 is the first vaccine developed in Latin America to reach the Phase III stage of clinical trials. It is one of the five vaccine candidates that Cuba has produced from its research and development of Covid vaccines. The Island’s other four vaccines include the Soberana 01, Soberana 01A (Plus), the Mambisa and the Abdala.
The Abala vaccine is also moving to Phase III clinical testing.
After evaluation of the results from the previous clinical trials, Phase I and II, it was demonstrated that the Soberana 02 showed adequate results and safety.
The Phase III clinical trial will involve 44,010 people between the ages of 19-80 years of age in eight municipalities of Havana.
This stage of testing will demonstrate the efficacy of the vaccine in the prevention of COVID-19.
Cuba’s advanced biopharma industry has already prepared over 300,000 doses of the vaccine and is preparing to ramp up production of the domestically manufactured vaccines with the expectation that trials will show Soberana-02 to be safe and effective.
Eduardo Martínez, the president of BioCubaFarma, announced that in the next few months millions more Cubans will receive the vaccinations.
Yesterday, members of the team that developed the Soberana Vaccines, held a press conference to answer questions and discuss on their work on the Covid-19 vaccines.
Iran has already begun widespread trials of Soberana-02. Mexico is in discussions with Cuba to begin trials. Suriname and Ghana are reportedly interested in purchasing the Cuban vaccines when they are ready.