Europe's Health Agency Accepts Moderna's Filing For Its Updated Omicron-Targeted COVID-19 Vaccine

The European Medicines Agency (EMA) has accepted a variation for evaluating Moderna Inc's MRNA 50 µg booster dose of the Omicron-containing bivalent COVID booster candidate for individuals 12 years and older.
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).
Related: As Moderna Grapples With Supply Shortage, FDA Gives Nod To Additional Lots of COVID-19 Booster.
The updated shot, mRNA-1273.222, targets both the original strain of SARS-CoV-2 and the BA.4/BA.5 subvariants of the Omicron strain.
Moderna's submission to the EMA is based on preclinical data for mRNA-1273.222 and clinical trial data from a Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, which recently received EMA approval.
Last week, Moderna asked the FDA to authorize the use of its updated booster shot in children ages 6 to 17. The company expects to complete a request for the use of the booster in children six months through 5 years later this year.
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