Moderna aims to expand mNEXSPIKE into Europe pending regulatory timelines and local market access, marking ongoing growth in the European respiratory vaccine market.

Moderna has filed for approvals in additional markets and already holds FDA and Health Canada approvals for mRNA-1283.

In the Phase 3 study, a 10 microgram dose of mRNA-1283 was evaluated against a 50 microgram dose of mRNA-1273.

Phase 3 results showed mNEXSPIKE had a safety profile similar to Spikevax, with fewer local reactions and common solicited adverse events including injection-site pain, fatigue, headache, and myalgia.

Moderna’s forward-looking statements address market opportunities, regulatory timelines, and global vaccine strategy, alongside standard risk disclosures.

The press release references ongoing endemic circulation of COVID-19 in Europe and includes remarks from Moderna’s CEO on strategic focus.

The press release contains forward-looking statements and standard risk disclosures, and provides contact information for media and investors.

The EMA CHMP issued a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283) for individuals 12 and older to prevent COVID-19.

Media and investor relations contact information is provided for further inquiries.

Phase 3 enrollment included about 11,400 participants, with mRNA-1283 showing a 9.3% higher relative vaccine efficacy overall versus mRNA-1273 starting 14 days after vaccination, and 13.5% higher efficacy among adults 65 and older.