European Regulatory Authority Backs Approval For Moderna's New Omicron Targeted COVID-19 Booster

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed conditional approval for Moderna Inc's MRNA updated omicron BA.4-5 COVID-19 vaccine booster for 12 years and above.
This vaccine now joins Moderna's other updated booster vaccine, mRNA 1273.214, that targets the BA.1 variant for use in individuals 12 years and older.
Related: Moderna's Omicron-Adapted Booster Maintains Response Through Three Months.
The updated vaccine 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's submission to the EMA is based on preclinical data for mRNA-1273.222 and clinical data from Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214).
A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.
Price Action: MRNA shares are down 7.90% at $123.49 on the last check Wednesday.
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