CECMED has been in charge of inspecting the facilities involved in the production process of vaccine candidates, with the intention of certifying good practices, in addition to evaluating and endorsing the quality of each batch
Author: Ventura de Jesús | ventura@granma.cu
May 11, 2021
«As a regulatory entity, we can say that the two vaccine candidates (Soberna 02 and Abdala) have an adequate safety profile. Regarding immunogenicity, we check the appearance of antibody titers and also their quality, which guarantees the elevation of the immune response ", said Olga Lidia Jacobo Casanueva, Master of Science, director of the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed).
With this hopeful explanation, during the television program Round Table, she argued that both drugs are safe and develop immune responses.
Regarding the inspection process and their subsequent approval as registered vaccines, she stated that they have not overlooked each of the stages of the research and development process, attached to the functions of the center and the necessary rigor.
Cecmed has been in charge, she said, of inspecting the facilities involved in the production process, with the intention of certifying good practices, as well as evaluating and endorsing the quality of each batch. Vaccinations are also validated. The scientist also recalled the need to comply with each of the steps.
On the intervention studies, she commented that they are perfectly recognized by international protocols, and have been decided on the basis of the evidence of safety and immunogenicity of the Cuban candidates. Even so, Cecmed maintains monitoring of each stage of the process. "It's well thought out, a decision justified by the evidence and collegial with our scientists," she said.
She defined the attempt to work with five vaccine candidates as a great challenge, and praised the work of Cuban scientists, the only ones on the planet with that number of proposals under development.
She explained that, only with Soberana 02 and Abdala, the two most advanced candidates, some 415,000 doses had been applied in two months, during the phases of clinical trials and intervention studies, with a low incidence of adverse events.
In arguing the decision to initiate health intervention in risk groups and territories, the Minister of Public Health, José Angel Portal Miranda, affirmed that the population wants and trusts the vaccine candidates, our science and the country's experience in the vaccine development.
As has been said, Cuba could be the first country to immunize its entire population with its own vaccines.