Second Group of Volunteers Join Soberana Clinical Trials

Twenty more Cubans joined the short history of Soberana 01, the country’s first candidate vaccine against COVID-19, on September 2, according to reports from Naturaleza Secreta.

Author: Granma | internet@granma.cu

September 10, 2020 10:09:54

Twenty more Cubans joined the short history of Soberana 01, the country’s first candidate vaccine against COVID-19, on September 2, according to reports from Naturaleza Secreta.

This group, composed of volunteers between 60 and 80 years of age, is the second to receive the first dose of the much awaited vaccine, that could make a significant contribution in the battle to contain the virus that is taking lives every day.

This step in the clinical trials took place after several other processes were completed, all carefully organized as part of the clinical trials that Cubans are following closely, hoping for the success that will allow for the entire population to be vaccinated against the new coronavirus.

Prior to the launching of the trials, in accordance with established protocols, all possible volunteers interested in participating where provided a full explanation of the process and signed an informed consent agreement.

A clinical trial is a study, an investigation conducted with volunteers, that on this occasion includes two phases. In the first, two groups were incorporated, one composed of volunteers between the ages of 19 and 59, and another including those aged 60 to 80. Each of these groups were randomly divided into three sub-groups given different doses of the vaccine under investigation or the vaccine VA-MENGOC-BC, as the control group, explained by Dr. Sonia Pérez Rodríguez.

She added that the candidate vaccine Soberana 01 is administered in two doses: the first on what is designated “day zero,” and a second dose 28 days later. The study ends 28 days after the administration of the second dose, thus giving the investigation a duration of 59 days.

The purpose of this phase is to determine if the vaccine is safe, to then be able to extend the study to a larger group of volunteers, and subsequently the population.

“It is a preventative vaccine, and this first phase has but one protocol, to allow us to evaluate the security of the product. This means that we record everything that occurs with the volunteers. If the vaccine is shown to be safe, we will continue the investigation. By evaluating two doses of the product, as the study advances, the most effective and safest dose will be identified, and that will be the one we use in subsequent stages of the clinical trials,” Dr. Pérez added.

Soberana 01 is the world’s 30th candidate vaccine against COVID-19, and the first in Latin America and the Caribbean to receive authorization for clinical trials. The first phase of the study began on August 24, when the proposed vaccine was administered to 20 volunteers between the ages of 19 and 59.

A productive online exchange on progress being made in developing a Cuban vaccine against COVID-19 took place recently between lead researchers at the Finlay Institute, representatives from the Pan American and World Health Organizations (PAHO/WHO), and the Coalition for Epidemic Preparedness Innovation (CEPI).

Carlos Fidel Martín Rodríguez, director of the Cuban Ministry of Foreign Trade and Investment’s International Economic Organizations department, reported the discussion on his Twitter account.

During the exchange, Vicente Vérez Bencomo, general director of the Finlay Institute, reported that trials of the candidate vaccine Soberana are revealing limited risks, raising few questions, and providing promising results in the pre-clinical phase currently underway, which began August 24 with administration of the vaccine to 20 persons between 19 and 59 years of age, and a week later, another 20 volunteers between the ages of 60 and 80.

All participants in the study, as a basic requirement, signed an informed consent agreement, and are in good health. Individuals with well-controlled chronic diseases were also included.

The second phase of the study is scheduled to begin October 30, with the incorporation of more volunteers to reach a total of 676 participants. Findings from the study are expected to be available in January of 2021, making certification of the Cuban candidate vaccine Soberana a process that will require several months.