Havana: Cuba continues today the clinical trial of the Soberana 01 vaccine candidate against Covid-19, by integrating a second group of 20 volunteers between the ages of 60 and 80, Prensa Latina publishes.
Moments prior to the process, people received the pertinent explanations following the established protocols.
The clinical trial is a study, it is an investigation carried out in volunteers, and this time it has two phases. In this first, we have divided two groups, one of volunteers between 19 and 59 years old, and another between 60 and 80 years old, Dr. Sonia Pérez explained.
Each group, in turn, will be randomly divided into three subgroups for the different doses of the research product, or for the control formula, which is the VA-MENGOC-BC vaccine, the specialist specified.
Pérez added that the vaccine candidate Soberana 01 is applied in two doses: the first day, which is called time zero, and then a second dose is given after 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 extended to a larger group of volunteer participants and then to the population, said the specialist quoted by the newspaper Granma.
‘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 we record. If the vaccine shows that it is safe, we move forward in the investigation?, she said.
“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 stick with for later stages of clinical trials?, Pérez stated.
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 newspaper recalls – the vaccine was administered to 20 people between 19 and 59 years old, starting the first phase of the clinical trial.
