Core Insights - Moderna (MRNA) received FDA approval for its next-generation COVID-19 vaccine, mRNA-1283, branded as mNexspike, with a narrower usage label than initially sought [1][8] - The approval aligns with the FDA's updated guidance focusing on vaccinating high-risk populations, specifically older adults aged 65 and individuals aged 12-64 with underlying health conditions [2][8] - mNexspike is Moderna's third FDA-approved product, joining Spikevax and mResvia [3] Product Details - mNexspike offers improved shelf life and storage benefits, making it advantageous for distribution in areas with limited cold-chain infrastructure [4] - Clinical data indicates that a 10 μg dose of mNexspike has a 9.3% higher relative vaccine efficacy compared to a 50 μg dose of Spikevax [4] Market Launch - Moderna plans to commercially launch mNexspike during the 2025-26 vaccination season [5] Stock Performance - Year-to-date, Moderna's stock has decreased by 35%, contrasting with a 4% decline in the industry [6] Recent Developments - Negative sentiment surrounds Moderna's stock due to the U.S. government terminating contracts worth $766 million for the development of an mRNA-based bird flu vaccine [9] - The FDA's new guidelines for COVID-19 vaccine boosters limit eligibility for healthy individuals under 65, potentially reducing demand [10] - Moderna voluntarily withdrew a regulatory filing for its COVID-19/influenza vaccine after the FDA requested additional efficacy data, delaying potential approval [10] Competitive Landscape - Other players in the COVID-19 vaccine market include Pfizer (PFE) with its mRNA vaccine Comirnaty and Novavax (NVAX) with its non-mRNA vaccine Nuvaxovid [11][12] - Novavax's Nuvaxovid has received full FDA approval for older adults and high-risk individuals aged 12-64, but is not yet approved for those under 12 [12]

Moderna(MRNA.O)获得美国食品药品监督管理局（FDA）批准其新冠病毒疫苗MNEXSPIKE。 ...