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 (NASDAQ: 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.

• Price Action: MRNA shares are up 1.20% at $123.70 on the last check Wednesday.

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