Application of second dose of phase III clinical trials of Soberana 02 and Abdala begins

Edited by Jorge Ruiz Miyares
2021-04-05 09:49:22


Havana, April 5 (RHC)-- Cuba's anti-Covid-19 vaccine candidates Soberana 02 and Abdala are entering the second dose of Phase III clinical trials on Monday.

The two formulations are part of a list of 24 sub-unit vaccines being developed globally, also included in the group of 16 that are currently advancing in the third stage of their trials.

This period's main purpose is to evaluate the efficacy, safety, and immunogenicity of the anti-SARS-CoV-2 vaccination, which causes the disease.  It is characterized by being multicenter, adaptive, parallel, randomized, placebo-controlled, and double-blind.

Soberana 02, from the Finlay Vaccine Institute (IFV), was the first formulation to start the study last March 8 in the capital with 44 010 volunteers from 19 to 80 years of age.

Its immunization schedule is zero, 28 and 56 days, and just a few days ago, its developers announced that all the subjects included in the research had received the first dose.

Meanwhile, the Abdala injectable, developed by the Center for Genetic Engineering and Biotechnology, Cuba's second proposal against Covid-19 to reach this stage, was launched with the first dose on March 22.

Designed with a short vaccination schedule of only four weeks (zero-14-28 days), this cycle was completed in 10 days in 48,000 volunteers in Santiago de Cuba, Guantanamo, and Granma provinces, where the disease has been highly prevalent in recent times.


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