HAVANA, Aug.19th Cuba will start next week the clinical trials of your own vaccine against the SARS-CoV-2 coronavirus, which will last until the beginning of 2021.Developed by the state-run Finlay Vaccine Institute, the drug will be called SOVEREIGN 01 and will be applied in two doses injected intramuscularly, according to the report published today, which did not specify more details about the nature of the vaccine.
The clinical trials, which will involve 676 people between 19 and 80 years old, will be divided into two stages, of which the first will begin next Monday 24.
The state centre has set the date of completion of the study of the vaccine, whose results would be available on February 1 to be published on the 15th of the same month.
The nearly five-month-long study will be « randomized, controlled, adaptive, double-blind, and multicenter » and the general objective of « evaluating the safety, reactogenicity, and immunogenicity » of the candidate drug has been set as a general objective. vaccine native Cuban for the COVID-19.
More specifically, in clinical trials the safety profile, reactogenicity and immunogenicity of SOVEREIGN 01, 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 of the Cuban Public Registry of Clinical trials.
Cuba It has an outstanding biotechnology and pharmaceutical industry that has allowed it to develop vaccines against meningitis, lung cancer (therapeutic) and solid tumours, among other diseases.
In the case of COVID-19, the announcement of the clinical trials for the new vaccine It comes at a time when there have been some outbreaks -mainly in Havana and surroundings- after the virus seemed to be under control.
Even so, the number of new daily cases remains in double digits, the total number of positives rises to 3,408, and the number of deaths is still 88 after fourteen days without deaths, low figures compared to the average for the countries in the region.