EMA accepted Moderna’s conditional Marketing Authorization filing for omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine

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On Sept. 28, 2022, Moderna announced that the European Medicines Agency had accepted a variation for the evaluation of a 50 ᄉg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) in adults 12 years and older.

Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 ᄉg of mRNA-1273 (Spikevax) and 25 ᄉg of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5).

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Source: Moderna
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