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EMA Recommends Authorization Of Moderna's Omicron BA.4-BA.5 Targeting Bivalent COVID-19 Vaccine

Moderna Inc. (MRNA) said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19.

The positive recommendation follows the recent approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, in September.

Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax bivalent Original/Omicron BA.4-5.

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

Moderna has received authorizations for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK to date and has submitted regulatory applications worldwide.

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