European Commission authorizes Moderna's mNEXSPIKE COVID-19 vaccine for people 12 and older

The European Commission granted marketing authorization for mNEXSPIKE, Moderna's lower-dose COVID-19 vaccine, for active immunization of people aged 12 and older. The decision followed a positive opinion from the EMA's human medicines committee and was based on a Phase 3 trial of about 11,400 participants. It adds a new market for the product, though European sales depend on local access timelines.

• Authorized for active immunization against COVID-19 in people 12 and older
• Valid in the EU27 plus Iceland, Liechtenstein and Norway
• Phase 3 trial of about 11,400 participants supported the decision
• Moderna expects availability in Europe pending local market access