Cuba will begin clinical trials of its own vaccine against the SARS-CoV-2 coronavirus next week, which will last until early 2021, the Cuban Public Registry of Clinical Trials reported this Tuesday.
Developed by the Finlay Vaccine Institute, the drug, named SOBERANA 01, will be applied in two doses injected intramuscularly, according to the report published yesterday, which did not specify more details about the nature of the vaccine.
The clinical trials, which will involve 676 people between the ages of 19 and 80, will be divided into two stages, the first of which will begin next Monday 24.
El director general del @FinlayInstituto, @BencomoVerez, explicó al Jefe de Estado los detalles y las etapas en el estudio y los avances en la #Vacuna específica contra la #COVID19, sobre los cuales se darán más detalles proximamente. #CienciaCubana @DiazCanelB @PresidenciaCuba pic.twitter.com/dCL5Tpq5a3
— Instituto Finlay (@FinlayInstituto) August 18, 2020
The Finlay center has set the completion of the study for January 11, 2021, and the results would be available on February 1 to be published on the 15th of the same month.
The nearly five-month study will be “randomized, controlled, adaptable, double-blind and multicenter” and the general objective is aimed at “evaluating the safety, reactogenicity and immunogenicity” of the drug candidate to be the Cuban autochthonous COVID-19 vaccine.
More specifically, in clinical trials the safety profile, reactogenicity and immunogenicity of SOBERANA 01 will be evaluated, to finally compare the immune response to the drug with different dose levels.
The proportion of subjects with an immune response is expected to be at least 50% higher than the control group, according to the report from the Cuban Public Registry of Clinical Trials.
Cuba has an outstanding biotechnology and pharmaceutical industry that has allowed it to develop vaccines against meningitis, lung cancer (therapeutic) and solid tumors, among other diseases.
In the case of COVID-19, the announcement of the clinical trials for the new vaccine comes at a time when some outbreaks have been registered―mainly in Havana and the surrounding areas―after the virus seemed to be under control.
Even so, the number of new daily cases remains in double digits, the total number of positive cases amounts to 3,408 and the deceased remain at 88 after fourteen days without deaths, low figures compared to the average of the region’s countries.