全球首款新冠以外的mRNA疫苗获批

第一财经06-01

5月31日，美国FDA批准了全球首款新冠以外的mRNA疫苗。美国疫苗厂商莫德纳（Moderna）研发的mRNA呼吸道合胞病毒（RSV）疫苗周五获得美国FDA批准，成为该公司继新冠疫苗之后的第二款商业化产品。莫德纳的RSV疫苗被批准用于预防60岁及以上成年人的呼吸道合胞病毒相关下呼吸道疾病。FDA称，该疫苗在预防呼吸道合胞病毒的至少两种症状（如咳嗽和发烧）有79%的有效性。在去年7月向FDA递交的...

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approved","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GSK":1,"CDC":1,"MRNA":0.9,"PFE":0.74,"GSK.UK":0.6},"content_text":"5月31日，美国FDA批准了全球首款新冠以外的mRNA疫苗。美国疫苗厂商莫德纳（Moderna）研发的mRNA呼吸道合胞病毒（RSV）疫苗周五获得美国FDA批准，成为该公司继新冠疫苗之后的第二款商业化产品。莫德纳的RSV疫苗被批准用于预防60岁及以上成年人的呼吸道合胞病毒相关下呼吸道疾病。FDA称，该疫苗在预防呼吸道合胞病毒的至少两种症状（如咳嗽和发烧）有79%的有效性。在去年7月向FDA递交的申请批准中，莫德纳的数据称该疫苗在预防这些症状方面有84%的有效性，该公司股价当天收盘下跌近6%。在新冠疫情常态化之后，新冠疫苗的需求急剧下滑，莫德纳迫切需要下一个商业化产品支撑其收入。根据LSEG的数据，分析师平均预测莫德纳的RSV疫苗2024年的销售额约为3.4亿美元，2025年有望增长至8.3亿美元。不过FDA的批准并不意味着该疫苗将马上投入市场，还需要等待美国疾病控制与预防中心 (CDC) 的建议。CDC的顾问小组将于下个月就该疫苗的使用和目标人群的建议进行投票。莫德纳预计，在美国符合接种条件的患者有望在今年秋季疫苗接种季获得该疫苗。在莫德纳的这款RSV疫苗获批前，葛兰素史克（GSK）和辉瑞的RSV疫苗产品已经展开激烈竞争，两款疫苗都获准用于60岁及以上的成年人。此外，辉瑞的疫苗还适用于怀孕32周至36周的妇女；GSK已申请将获批的年龄组扩大到50-59岁的成年人。RSV感染后的症状类似于感冒，但对幼儿和老年人来说可能是致命的，每年导致上万名老年人死亡。尽管此前数据显示，mRNA技术路线RSV疫苗较GSK和辉瑞的疫苗而言，疫苗效力下降的速度更快，但莫德纳仍然表示，mRNA疫苗可以教导人体制造免疫系统可以识别和攻击的特定蛋白质，具有治疗多种疾病的潜力，并且比传统疫苗更有效。值得关注的是，此前莫德纳已经在中国宣布建造疫苗生产设施，这款最新的RSV疫苗未来是否将引入中国市场也令人期待。","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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