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 on Tuesday.
Developed by the state-run Finlay Vaccine Institute, the drug will be called SOBERANA 01 and will be applied in two doses injected intramuscularly, according to the report published on Tuesday, 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 on Monday 24.
The state center has set the date of completion of the vaccine study at January 11, 2021, the results of which 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, adaptive, double-blind and multicenter” and the general objective of “evaluating the safety, reactogenicity and immunogenicity” of the drug candidate to be the Cuban autochthonous vaccine for COVID has been set. -19.
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 there have been some outbreaks -mainly in and around Havana- after the virus seemed controlled.
Even so, the number of new daily cases remains in double digits, the total number of positives rises to 3,408 and the deaths are 88 after fourteen days without deaths, low figures compared to the average of the countries in the region.