European Medicines Agency accepts Moderna's conditional marketing authorisation filing for its Omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine

Moderna

28 September 2022 - Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, in September.

Moderna today announced that the EMA has accepted a variation for the evaluation of a 50 µg 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.

Read Moderna press release

Michael Wonder

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Michael Wonder

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Europe , Vaccine , Dossier , COVID-19