CHMP Backs EU Approval of MRNA's New COVID-19 Vaccine mNexspike

Core Viewpoint - Moderna's mNexspike vaccine has received a positive opinion from the EMA's CHMP, recommending EU approval for its next-generation refrigerator-stable COVID-19 vaccine aimed at individuals aged 12 and older [1][6]. Group 1: Product Approval and Market Strategy - A final decision from the European Commission regarding mNexspike is anticipated soon, with plans for distribution across Europe following regulatory timelines [2]. - mNexspike is Moderna's third product to receive a positive CHMP opinion, joining Spikevax and mResvia, indicating a growing portfolio in the vaccine market [3]. - The approval of mNexspike could enhance Moderna's growth outlook by strengthening its respiratory franchise and generating incremental revenues in the EU starting in 2026-2027 [8]. Group 2: Efficacy and Safety Data - The positive opinion for mNexspike is based on a phase III study with approximately 11,400 participants, demonstrating non-inferior vaccine efficacy compared to Spikevax, with a 9.3% higher relative vaccine efficacy overall and 13.5% higher in adults aged 65 and older [4][6]. - Safety profiles for mNexspike are comparable to Spikevax, showing fewer local reactions and similar rates of systemic adverse events, with common side effects including injection-site pain, fatigue, headache, and myalgia [5][6]. Group 3: Market Context and Demand - COVID-19 remains prevalent in the EU, with ongoing demand for updated vaccines, particularly for high-risk populations such as the elderly, due to waning immunity and the emergence of new variants [9]. - mNexspike offers improved shelf life and storage benefits, which are crucial for distribution in areas with limited cold-chain infrastructure [11].