Photo: YURI CORTEZ / AFP / Getty Images
The Federal Commission for the Protection against Sanitary Risks (Cofepris) in Mexico announced the authorization for emergency use of the Cuban vaccine Abdala.
Through a statement, Cofepris specified that said biological has the distinctive name “recombinant protein of the receptor-binding domain of the SARS-CoV-2 virus.”
The Committee for New Molecules (CMN) met on the use of this biological, which received a favorable technical opinion from the experts. In clinical trials, Abdala showed an efficacy of 92. 2 percent .
After integrating the opinion of the CMN and submitting the authorization request for emergency use before Cofepris, personnel specialized in vaccines analyzed the files, certifying that Abdala meets the requirements of quality, safety and efficacy necessary to be applied.
“The authorizations issued This Commission is part of the National Strategy for Health Regulation, which allows reviewing and giving access to the greatest number of health supplies, as long as the quality, safety and efficacy of the product is verified ”, the document adds.
As a reference National Regulatory Authority (ARNr), qualified by the Pan American Health Organization (PAHO), Cofepris decisions are recognized by various countries of the region, for which approved vaccines are likely to be used in other nations.
Mexico becomes like this in one of the first countries to authorize this vaccine, not recognized for emergency use by the World Health Organization (WHO ), which joins the other nine that are being used to immunize the population in full swing of infections by the Omicron variant.
Before, Cofepris already authorized the emergency use of COVID Vaccines – 19 from Pfizer-BioNTech, AstraZeneca, CanSino, “Sputnik V”, Sinovac, Covaxin, Janssen , Moderna and Sinopharm.
In response, BioCubaFarma, the business organization that produces medicines , high-tech equipment and services on the Island, mentioned that, “With this approval, Mexico can import the Abdala vaccine, for use in the National Vaccination Policy against the SARS-CoV-2 virus in older people d e 19 years ”.
The biopharmaceutical complex assured in the social network that in this way “the international insertion” of the Cuban formulas against COVID advances – 19, an objective of the Cuban Government.
In addition to Abdala, Cuba has two other formulas against covid – 19: Sovereign 02 and Soberana Plus , which received authorization for emergency use by the Cuban regulatory entity, the Center for State Control of Medicines, Medical Equipment and Devices.
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