Havana, Oct 19.- The Finlay Vaccine Institute of Cuba announced the registration of a new clinical trial in the public registry to evaluate different formulations and dose schedules of the nationally produced drug against Covid-19, Sovereign 01.
As detailed by the institution in its official Twitter account, the studies carried out so far have shown the safety of the Cuban vaccine and the best will advance to higher phases of clinical trials.
This second project against Covid-19, called Sovereign 01 A, will be carried out in parallel to the first trial registered by Finlay, which seeks to evaluate safety
Incorporated into the public registry of the regulatory authority of the Island's Center for State Control of Medicines, Equipment and Medical Devices (Cecmed), another objective of the new research is to explore the immunogenicity of different formulations of the FINLAY FR vaccine candidates- 1 and FINLAY FR-1A in different schemes.
Recently, the director of the Finlay Vaccine Institute, Vicente Vérez, announced that this project is different, with the same antigen, but with another platform.
When referring to the effectiveness of this new immunizer, Vérez stressed that it is giving very interesting answers and would move quickly.
Cuba announced on August 19 the start of clinical trials of Soberana 01, a vaccine candidate against Covid-19 made in the country, which was approved for Phase I / II studies by Cecmed.
The investigation, which began on August 24 and should conclude its stages in January 2021, is expected to be available to people by February of that year. The sample of volunteers will cover 676 people between 19 and 80 years old in all its phases.
Soberana 01 joined about 40 candidates worldwide who received authorization from the World Health Organization to advance the clinical trial in humans. (Text and photos: PL)