Moderna announced today that the application process to the US Food and Drug Adminitration (Fda) for the full authorization of its Covid vaccine is completed. The trial began in June. Therefore, only the FDA verdict is now missing to collect the final ok for the active immunization product aimed at preventing Covid in people aged 18 and over. The CEO, Stéphane Bancel, speaks of an “important milestone” not only for the battle against Covid, but also for the company. It is in fact, “the first presentation of a Bla” application for a biological license, “in the history of Moderna”. As part of the completed Bla presentation, Moderna had requested the designation of the priority overhaul. “We are delighted that our Covid vaccine shows long-lasting efficacy of 93% six months after the second dose,” continues Bancel, who in a note thanked everyone, from those who participated in the vaccine studies to the team of the company that has “Relentlessly” pursued “the mission of delivering on the promise of mRNA science.” The full presentation includes clinical data from the Cove Phase 3 Modern Covid-19 vaccine study, which enrolled more than 30,000 participants and was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (Niaid), center of the Nih (National Institutes of Health), and the Biomedical Advanced Research and Development Authority (Barda). The Moderna vaccine is currently available for those over 18 under an Emergency Use Authorization (Eua) granted by the FDA on December 18, 2020. The US regulatory body has also been applying for an emergency use authorization for adolescents aged 12 and over.
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