ROME, Aug 24 (Adnkronos Salute) — Moderna has completed filing an application with the U.S. Food and Drug Administration, the United States drug agency, for emergency use of a bivalent vaccine adapted to Omicron variants 4 and 5. This was announced by the biotech company. American. Claim a booster dose of 50 mcg for adults aged 18 years and over and is based on available preclinical and clinical trial data for the bivalent booster candidate (mRna-1273.214) versus the first Omicron variant, BA.1. As for the new product versus the latest sub variants, there is no data yet. Moderna has developed Enhanced Filter (mRna-1273.222) against BA.4 and BA.5 in accordance with FDA guidelines, and is now conducting a Phase 2/3 study and has prepared production to be ready if it arrives. The regulatory body, to administer doses in September. “Modern’s mRna platform has allowed us to develop, study and distribute bivalent booster vaccines, which show greater protection against all types of Covid tested, in record time,” said Stéphane Bancel, CEO of Moderna.
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