Cuba approved the second phase of clinical trials for its Soberana 02 COVID-19 vaccine candidate after registering preliminary positive results in the first phase of studies on humans, the Finlay Vaccine Institute (IFV) reported this Thursday.
The IFV director general stated that this new phase of the study will involve a group of 100 volunteers who will receive the drug, plus another larger group―between 300 and 600 people―in which, in addition to the vaccine project, a placebo will be included, according to Granma newspaper.
Se aprueba inicio de ensayo clínico Fase II con la vacuna #Soberana02, tras resultados positivos preliminares de la Fase I. Otra vez, es cubana la primera vacuna latinoamericana en avanzar a Fase II. #CubaViva #CienciaCubana @BioCubaFarma pic.twitter.com/sq7cAzPlgd
— Instituto Finlay (@FinlayInstituto) December 17, 2020
The third phase of the study will be more complex, due to the low incidence of COVID-19 in the country, and should include around 150,000 people, the source indicated.
Soberana 02 became the first coronavirus vaccine from a Latin American country that is advancing to the second phase of clinical trials.
It is an innovative drug, as it is unprecedented among all those being developed to face the disease caused by the SARS-CoV-2 virus in the world, said Dr. Vérez. The scientist explained that in this candidate the virus antigen and tetanus toxoid are combined.
In November it was included by the World Health Organization (WHO) in the official register of COVID-19 projects in phases of clinical trials.
Scientists at the Finlay Institute are confident that their other vaccine project, Soberana 01, will also complete the first phase of human trials before the end of 2020.
Cuba has two other candidates against the contagious disease, Abdala and Mambisa, developed at the Center for Genetic Engineering and Biotechnology (CIGB).