Thus, Abdala becomes the first vaccine in Latin America, produced and elaborated in the region.

The Center for the State Control of Medicine, Equipment and Medical Devices (CEDMED) decided this Friday to grant the Emergency Use Authorization(AUE) to the Cuban vaccine Abdala 50 ug, whose holder is the Center for the Genetic Engineering and Biotechnology (CIGB), in accordance and in compliance with the provisions of the regulations and provisions in force, once it was confirmed that it complies with the requirements and parameters demanded in terms of quality, safety and efficacy for this type of procedure.

After concluding a rigorous evaluation process for the dossier submitted to CEDMED, for the application of AUE and after having carried out the inspections to the plants involved in the production process, once confirmed that the compliances with the established requirements and from the results obtained in Phase I and Phase II clinical trials concluded and Phase III in execution, which has demonstrated an efficacy in the prevention of symptomatic forms of the disease of a 98.28%, as well as adequate safety profile, supported by the number of doses applied in the clinical trials carried out, the intervention study in populations at risks and the health intervention carried out in our country.

Considering the above, CEDMED makes the effective approval through Resolution No. 113 of July 9, 2021, approved by its director.

Therefore, Abdala becomes the first vaccine in Latin America, produced and developed in the region with an Emergency Use Authorization.

Source: Cubadebate