CECMED grants emergency use authorization (EUA) to the Cuban vaccine candidate Abdala


On 9 July 2021, the Center for State Control of Medicines and Medical Equipment and Devices (CECMED) granted emergency use authorization (EUA) to the Cuban vaccine ABDALA 50 μg, developed by the Cuba's Center for Genetic Engineering and Biotechnology (CIGB). 

The authorization was granted once an evaluation of the file submitted by CECMED for the EUA had been completed, inspection of the plants involved in the production process had been carried out, and compliance with the official requirements had been confirmed. Data from Phase I and Phase II clinical trials, with a Phase III clinical trial now in progress, demonstrated 92.28% efficacy in preventing symptomatic forms of the disease, as well as an adequate safety profile, supported by the number of doses administered in the clinical trials to date, the intervention study in at-risk populations, and the health intervention conducted in the country.

Source: https://www.cecmed.cu/noticias/aprueba-cecmed-autorizo-uso-emergencia-candidato-vacunal-cubanoabdala   

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