Cuba begins third-phase clinical trial of one of its vaccine candidates in eastern region and continues studies in Havana

HAVANA, Cuba, Mar 22 (ACN) On the road to the vaccination of the entire Cuban population, this week will be very busy and significant with the start, today, of the third phase of the clinical trial of the Abdala vaccine candidate in three eastern provinces.
This will be applied to 48,000 volunteers 19 to 80 years of age in Santiago de Cuba, Guantanamo and Granma.

At the same time, in Havana, Soberana 02, the most advanced of the Cuban immunogens, will be used in an intervention trial in several certified institutions to evaluate the direct and indirect effects of vaccination in population groups at risk of infection, disease and spread of the epidemic.
The study will include 150, 000 volunteers belonging to the risk group of health workers, the biopharmaceutical industry and other sectors defined by the Ministry of Public Health.

Likewise, after the approval of Phase III, on March 3, the trial began and after 10 working days it has been completed, with the inclusion of 100 % of the volunteers planned for this period and with which 17, 000 Havana residents have been vaccinated.
The two vaccine candidates have shown safety, high immune response and few adverse reactions mainly related to pain at the injection site.

Therefore, in this third stage, apart from the safety, immunogenicity and reactogenicity of the Cuban anti-COVID-19 drugs, the efficacy will be evaluated, which, according to the researchers, they hope to achieve with indicators at the level of the vaccines produced on an international scale.
Depending on the results of the Phase III clinical trials and the improvement of the immunization systems, Cuba intends to start vaccination in mid-2021, said Rolando Perez Rodriguez, director of Scientific Policy of the BioCubaFarma business group, during his recent participation in the Mesa Redonda information program.

Besides, starting in April, it is expected to obtain authorization from the corresponding authorities to start the trials of Soberana 01 in the central province of Cienfuegos, and the combined study of Soberana 01 and Soberana 02 in pediatric populations, mainly in the 12 to 18 years of age range.

Regarding Soberana Plus, and according to information from the Cuban Public Registry of Clinical Trials, a Phase I study is being designed that includes 60 persons between 19 and 59 years of age, healthy and without contact with positive cases of COVID-19.

Also, the product, based on one of the formulations of Soberana 01, is designed for convalescents of the disease and is applied as part of the Soberana 02 trial as a third dose with a view to strengthening immunity.

As for Mambisa, its investigators are redirecting the use of the vaccine candidate for use in COVID-19 pandemic convalescents and booster doses of other vaccines, both Cuban and foreign.