The Committee for New Molecules gave a unanimous favorable opinion for the authorization of the emergency use of the Vero Cell Inactivated vaccine from the Sinopharm laboratory, the Federal Commission for the Protection against Sanitary Risks (Cofepris) reported on Monday.
“The authorization for emergency use of the vaccine against COVID-19 Sinopharm, prequalified by the World Health Organization (WHO), on May 7, 2021, was requested by Laboratorios de Biológicos y Reactivos de México SA de CV ( Birmex), for its application in people over 18 years of age ”, added Cofepris in a statement.
The Committee on New Molecules also gave a unanimous favorable opinion on the sanitary registration of the drug with active ingredient remdesivir for the treatment of people with Covid-19, added Cofepris.
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Both opinions, according to the agency, represent an advance in the approval processes necessary to meet the quality, safety and efficacy requirements, essential when considering a product.
“The next step consists of submitting files by each pharmacist, which will be ruled by expert personnel from the Sanitary Authorization Commission,” he explained.
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