They formally authorize emergency use of the Cuban vaccine Abdala

The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) formalized the authorization of the Emergency Use (AUE) to the Cuban vaccine ABDALA 50 µg, whose owner is the Center for Genetic Engineering and Biotechnology CIGB, in accordance and in observance of the provisions of the regulations and provisions in force, once it has been confirmed that the requirements and parameters demanded in terms of quality, safety and efficacy are met for this kind of Procedure.

After concluding a rigorous evaluation process of the file presented to CECMED, for the AUE request and having carried out the inspections to the plants involved in the production process, once it has been confirmed that the established requirements are met and based on the data obtained in the completed Phase I and Phase II Clinical Trials and a Phase III Clinical Trial in progress, which has shown efficacy in the prevention of symptomatic forms of the disease of the 92.28 %, as well as an adequate safety profile, supported by the number of doses applied in the clinical trials carried out, the intervention study in risk populations and the health intervention carried out in the country.

Resolution-113-AUE-Abdala

 

SPONSORED LINKS

				
					<div class="fb-comments" data-href="<?php the_permalink(); ?>" data-width="100%" data-numposts="5">&nbsp;</div>