The first stage of clinical trials for the definitive validation of Soberana, the Cuban candidate vaccine authorized to begin this phase, began August 24, with the administration of the product to 20 volunteers, between the age of 19 and 59.
Over the course of the week, the safety of the candidate vaccine was evaluated and the findings submitted to the Center for State Control of Medications (Cecmed), which should lead to authorization to begin trials with an equal number of subjects in the 60 to 80 age group.
The second stage is expected to begin October 30, reaching the total projected of 676 volunteers between 19 and 80 years of age. The clinical trials should conclude in early 2021, with the results to be published in February.
To participate in the study, volunteers must sign an informed consent agreement and be healthy, although Individuals with chronic diseases which are well controlled are also included. Worth noting is the fact that the candidate vaccine Soberana was previously tested for adverse reactions in humans, specifically three of the project’s lead researchers, with very positive results.
Given the time period normally required to develop a specific vaccine, the
finlay-fr-1 project has the merit of reaching this stage in record time, within only three months, thanks to the tireless work of scientists at the Finlay Vaccine Institute (ifv) and the Molecular Immunology Center, with the collaboration of the University of Havana’s Chemical and Biomolecular Synthesis Laboratory.
Prior to this milestone, the pharmaceutical phase was successfully completed with testing of the candidate vaccine in animals, providing the findings which made the next step possible: testing with human subjects, led by the ifv which has developed a number of vaccines that testify to the institution’s high standards of scientific work.
IFV director Vicente Vérez Bencomo explained that the experience gained by Cuban science in the development of other vaccines proved to be essential to the present effort, also noting that, given the pandemic circumstances reigning in the world, adaptations were made to the international regulatory system, allowing timeframes to be shortened, as long as rigor was maintained in completing each of the established steps.
According to information provided by the state enterprise group BioCubaFarma, if the clinical trials produce the hoped-for results, a large scale production strategy has already been prepared for what will then officially be Cuba’s anti-COVID-19 vaccine.
To the pride of our country, and a great tribute to the eternal promoter of Cuban biotechnology, Fidel, our candidate vaccine is the 30th in the world to receive authorization for clinical trials, the first in Latin America and the Caribbean. And a testament to the deep commitment of Cuban scientists to playing their part in the country’s battle against the pandemic.
(Source: Granma)