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    Home > Medical News > Medical Research Articles > The Omicron new crown bivalent vaccine booster needle is authorized for emergency use by the US FDA

    The Omicron new crown bivalent vaccine booster needle is authorized for emergency use by the US FDA

    • Last Update: 2022-09-07
    • Source: Internet
    • Author: User
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    The heat about COVID-19 vaccine genenews has slowed


    Yesterday, the FDA approved the Emergency Use Authorization (EUAs) for the Moderna COVID-19 vaccine and the Pfizer-biontech COVID-19 vaccine to authorize new formulations


    The goal is to provide better protection against COVID-19


    "The COVID-19 vaccine, including enhancers, continues to save countless lives and prevent the worst consequences of COVID-19 (hospitalizations and deaths)," said FDA Commissioner Robert M.


    For each divalent COVID-19 vaccine, the FDA's decision is based on all available evidence, including broad safety and efficacy data for each monovalent COVID-19 vaccine, as well as safety and immunogenicity data obtained from clinical studies of a bivalent COVID-19 vaccine that contains the mRNA of the omicron variant ba1 line similar to each vaccine being approved, and non-clinical data obtained using a divalent COVID-19 vaccine containing the original strain mRNA, as well as mRNA


    Use only as a booster needle

    The updated Moderna COVID-19 vaccine is licensed as a single booster in individuals 18 years of age and older


    Anyone 18 years of age and older who is eligible for a single booster of the updated Moderna COVID-19 vaccine is eligible for a single booster of the updated Moderna COVID-19 vaccine at least two months after completing primary vaccination or receiving the most recent booster for any authorized or approved COVID-19 monovalent


    People 12 years of age and older who are eligible for one Pfizer-biontech updated COVID-19 vaccine booster at least two months after completing primary vaccination or receiving the latest booster for any authorized or approved monovalent COVID-19 vaccine


    Pfizer Noting notes that an Omelon bivalent vaccine for children aged 5 to 11 years is scheduled to be submitted to the FDA in early October, and the two companies are working with the FDA to prepare an application for


    "The FDA has been planning that the composition of the COVID-19 vaccine may need to be modified to address the variants


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