智通财经APP获悉，在历经漫长等待后，诺瓦瓦克斯医药(NVAX.US)研发的新冠疫苗终于获得美国食品药品监督管理局(FDA)批准。受此利好消息刺激，该公司股价在周一盘初一度暴涨逾27%。
根据FDA发布的公告，此次获批的Nuvaxovid疫苗适用于两类人群：一是65岁及以上老年群体;二是12至64岁且至少患有一种基础疾病、可能引发新冠肺炎重症的高风险人群。
该批准基于关键性三期临床试验数据，根据诺瓦瓦克斯医药与赛诺菲(SNY.US)于2024年达成的授权协议，此次获批将触发1.75亿美元的里程碑付款。
据了解，Nuvaxovid是美国目前唯一一款基于重组蛋白技术路线、非mRNA工艺的新冠疫苗。
诺瓦瓦克斯医药表示，待2025年5月22日FDA疫苗及相关生物制品咨询委员会会议确定毒株推荐意见后，公司计划与赛诺菲合作，于今年秋季在美国市场推出2025-2026年度新版新冠疫苗。
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