An Emergency Use Authorization request for the version of the bivalent vaccine against covid-19, developed by the pharmaceutical company Moderna and marketed by Adium, was submitted to the National Health Surveillance Agency (Anvisa), this Friday (17). ANVISA, the bivalent vaccine contains a mixture of strains of the SARS-Cov-2 virus and promises to provide greater protection to the Omicron variant, when compared to monovalent vaccines. Due to its transmissibility, notes the agency, the Ômicron variant causes concern to health authorities in the country. Adium had submitted the application for registration of the vaccine in January. “This request is under analysis by Anvisa’s technical team. However, the company decided to file the Emergency Use Authorization, in parallel with the registration request, in accordance with the favorable opinion of the Ministry of Health, as provided for in the sole paragraph of Art. 1 of Resolution (RDC) 688, of May 13, 2022”, explained the agency, in a note. Emergency Use Once the Emergency Use Authorization request has been received, Anvisa has 30 days to conclude its evaluation. This deadline is interrupted whenever it is necessary to request the company to supplement information or clarifications on the quality, efficacy and safety data presented.
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