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Pfizer And Biontech Submit Application To FDA For Emergency Use Authorization Of Omicron Ba.4/ba.5-Adapted Bivalent Covid-19 Vaccine

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older Companies have rapidly scaled
byBenzinga Newsdesk
August 22, 2022
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  • Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older
  • Companies have rapidly scaled production and stand ready to deliver doses of Omicron BA.4/BA.5-adapted bivalent vaccines for September, and will begin shipping immediately pending authorization
    • Rolling submission for Omicron BA.4/BA.5-adapted bivalent vaccine to be completed with the European Medicines Agency in the coming days
 
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