27 de enero de 2022

Second group of volunteers joins the Soberana 01 validation process 

Twenty more Cubans this Wednesday joined the second phase of Soberana 01 clinical study, Cuba’s first vaccine candidate against COVID-19, according to reports from Naturaleza Secreta.

They are between 60 and 80 years old and are the second group of volunteers who will receive the first dose of this hopeful proposal, which seeks to win the battle against the pandemic that takes lives every day.

They arrive at this moment after several previous steps, all exquisitely organized, planned as part of a necessary study to which all Cubans hopefully wait for success in order to subsequently immunize the entire population against the new coronavirus.

As part of this clinical trial, in previous moments, following the established protocols, explanations were carried out to all possible volunteers to be incorporated.

The clinical trial is a study, it is an investigation that is done in volunteers, and that this time has two phases. In this first one, we have divided two groups, one of volunteers between 19 and 59 years old, and another between 60 and 80 years old.

Each group, in turn, will be divided randomly into three subgroups for the different doses of the research product, or for the control product, which is the VA-MENGOC-BC vaccine, according to Dr. Sonia Perez Rodriguez’s explanations.

He added that Soverana 01 vaccine candidate is applied in two doses: the first day, which is called time zero, and then a second dose is given at 28 days. The investigation ends 28 days after the second dose is applied, that is, a total of 59 days.

The purpose of this trial is to determine if the vaccine is safe so that it can be spread to a larger group of volunteer participants and then to the population. «It is a preventive vaccine, it is a single protocol that has this first phase, where we have to measure the safety of the product. It means that everything that happens with volunteers is taken into account and analyzed. If the vaccine is shown to be safe, we move forward with the research.

By evaluating two doses of the product, as the research progresses, it will be demonstrated which is the most effective and safest dose, and that will be the one we will use for later stages of clinical trials, «said Dr. Perez Rodriguez.

Soberana 01 is the 30th vaccine candidate in the world and the first in Latin America and the Caribbean to receive authorization for clinical trials.

On August 24, the vaccine was administered to 20 people between 19 and 59 years old, starting the first phase of the clinical trial.

(Translated by Yeney Perez Corona from Granma)

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