HAVANA, Cuba, Aug 21 (ACN) Soberana 01, the Finlay Vaccine Institute's challenge, is the first vaccine candidate approved for clinical trials to be created in a Latin American country and a non-developed nation.
This was announced by Dr. Vicente Verez Bencomo, director of the Finlay Institute of Vaccines, on the Mesa Redonda TV program on Thursday. He explained that of the more than 200 candidates who have begun to be developed around the world, only 30 have reached this stage.
The specialist stated that achieving a vaccine candidate in three months would be impossible, if not for the fact that the world regulatory system understood the need to make changes in times, maintaining safety elements but managing to shorten the steps.
Based on the knowledge gained in the world and the experience of the Cuban researchers, Verez also explained that in late April and early May they found themselves in a position to use a strategy that allowed them to reach a possible solution.
The director stressed that the fact that Soberana 01 has been authorized to move to the clinical trial phase in the first of the four stages represents a great deal, since the first step of the rest of the journey has already been reached.
With this step already completed in only three months, a very important level is achieved in terms of COVID-19, and Cuban scientists consider this a landmark for the accuracy followed: we have accomplished everything even though time has been accelerated, he stressed.
For its part, CECMED, the Cuban regulatory authority for medicines, equipment and medical devices, participated in each process and was present from the first stages of the formulation of the Cuban vaccine candidate.
The head of the institution, Yaquelin Rodriguez Valdes, who spoke on the same TV program, emphasized that due to the strengths of the Cuban regulatory body, on August 13 a process with several advantages was concluded, since CECMED knows the industry, registers its products, certifies its good practices, monitors and approves the products, and therefore its specialists have the same level as those in the regulated sector.
This entity has worked with the Cuban pharmaceutical and biotechnology industry since its support in the current emergency situation caused by COVID-19, in launching innovative products, such as the vaccine, the expert concluded.