On August 27, 2025, the FDA approved Moderna's Spikevax vaccine (COVID-19 Vaccine, mRNA) in the 2025–2026 formulation for persons older than 65 years and for individuals 6 months to 64 years of age with at least one underlying medical condition that increases the risk of severe COVID-19[1][2][3][4]. On the same day, the FDA revoked the Emergency Use Authorization (EUA) for the earlier Moderna COVID-19 Vaccine (2024–2025 Formula)[2][3][4]. Moderna has confirmed that it has ceased production and distribution of the vaccine under the EUA following the approval of the new formulation[2]. Moderna's mNEXSPIKE (mRNA-1283) vaccine received approval on May 31, 2025 for adults over 65 years of age and persons 12–64 years of age with risk factors[1][5]. In a phase 3 clinical trial with approximately 11,400 participants, mNEXSPIKE demonstrated 9.3% greater relative efficacy compared to the original Spikevax vaccine in subjects over 12 years of age and 13.5% greater efficacy in subjects over 65 years of age[1]. Moderna expects Spikevax and mNEXSPIKE vaccines to be available for the 2025–2026 respiratory virus season[1][5][7]. Moderna CEO Stéphane Bancel said that COVID-19 remains a serious threat, with more than 47,000 Americans dying from it last year[1]. At the same time, the FDA also approved the updated 2025–2026 vaccines from Pfizer, BioNTech, and Sanofi/Novavax and revoked their previous EUAs[3][6].