Cuban scientific center guarantees safety of clinical trial in Soberana01

HAVANA, Cuba, Sep 3 (ACN) For just over a week, the National Center for the Coordination of Clinical Trials (CENCEC by its Spanish acronym) has been responsible for evaluating the clinical trial of Soberana01, the first Cuban vaccine candidate against COVID-19 developed by the Finlay Institute of Vaccines.

Julian Rodriguez Alvarez, head of the marketing, regulatory affairs and international cooperation department of CENCEC, explained, in an exclusive interview to the Cuban News Agency, that once the trial starts, a decisive stage for the registration of a new biopharmaceutical product, the institution's goal is to provide the safety of the volunteers involved.
The institution, he stated, is part of the execution service of Soberana01's study after the inclusion of the patients, after the approval of the vaccine candidate by the Cuban regulatory entity, the Center for the State Control of Drugs, Equipment, and Medical Devices (CECMED by its Spanish acronym).
We guarantee the reliability of the data at this stage, through a methodological exercise to assess the progress of the study in terms of the information that is being generated, the expert added.
Currently, the experimental evaluation of the Cuban candidate, which is also the first one of its kind in Latin America, is in its development phase I-II, where volunteers from two different age groups are applied 28 days of the vaccine that intends to provide certain protection against the SARS-Cov-2 coronavirus.
CENEC, with more than 25 years of experience in monitoring this type of evaluation, considers the Soberana01 trial as a challenge for its staff because it is not the type of evaluation that the entity usually conducts, in addition to the fact that a study of this type requires the participation of several organizations.