The Federal Commission for the Protection against Sanitary Risks (Cofepris), ruled the authorization for emergency use of the Abdala vaccine, developed by the Center for Genetic Engineering and Biotechnology of the Ministry of Public Health of Cuba, whose composition is made based on the Principles of Generic Engineering with the SARS-CoV-2 Virus Receptor-Binding Domain Recombinant Protein.
After the authorization request was submitted, personnel specialized in vaccines analyzed the files and certified that the biological meets quality, safety and efficacy requirements to be supplied with therapeutic indication for active immunization to prevent COVID-19 disease. It should be noted that on August 30, Cofepris announced that the Committee for New Molecules (CMN) issued its favorable opinion regarding the biological one, making it the first of Latin American origin to be evaluated by this body.
Through a statement, the Commission indicated that the authorizations issued by this commission are part of the National Strategy for Sanitary Regulation, which allows reviewing and giving access to the largest number of health supplies, as long as the quality, safety and efficacy of the product are verified.
Likewise, it was highlighted that, as a reference National Regulatory Authority (rRNA), qualified by the Pan American Health Organization (PAHO), Cofepris decisions are recognized by various countries in the region, therefore the approved vaccines are susceptible to be used in other nations.
In this way, the Abdalá vaccine was added to the vaccines against COVID-19 approved by the federal body since last December 2020, among them are the following biologics: Pfizer-BioNTech, AztraZeneca, CanSino Biologics, Sputnik V, Sinovac , Covaxin, Moderna, Janssen and Sinopharm, developed by the China National Pharmaceutical Group.
Information in development …