2026年8月5日 美国东部时间晚上11:09 / 哥伦比亚广播公司新闻
美国食品药品监督管理局已批准莫德纳公司一款采用mRNA技术的新型季节性流感疫苗，这家制药商周三宣布。
这款名为mFLUSIVA的疫苗获批用于50岁及以上成年人，是首款获得FDA批准的mRNA技术流感疫苗。
莫德纳在一份声明中表示：“此次批准也彰显了我们mRNA平台的持续潜力，即通过持续的科学创新助力应对重大公共卫生挑战。我们感谢临床试验参与者、研究人员、监管机构以及莫德纳团队，是他们的付出成就了这一里程碑。”
此次批准此前经历波折：FDA今年早些时候曾表示将拒绝审议莫德纳的申请，但随后改变立场，允许该疫苗进入审查流程。
这场争议的核心是一项涉及4万人的临床试验，该试验发现，对于50岁及以上成年人，莫德纳的这款新疫苗比目前使用的一款标准流感疫苗更有效。
本文为持续更新的报道，后续将补充更多信息。
FDA approves Moderna’s mRNA flu vaccine after initial pushback
August 5, 2026 11:09 PM EDT / CBS News
The U.S. Food and Drug Administration has approved a new seasonal flu vaccine from Moderna that uses mRNA technology, the drugmaker announced Wednesday.
mFLUSIVA, approved for adults ages 50 and older, is the first influenza vaccine using mRNA technology to receive FDA approval.
“This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible,” Moderna said in a statement.
It comes after the FDA had earlier this year said it would refuse to consider Moderna’ application, but later reversed course and stated it would allow the vaccine to proceed to review.
The dispute had centered on a 40,000-person clinical trial that found Moderna’s new vaccine was more effective in adults aged 50 and older than one of the standard flu shots used today.
This is a developing story and will be updated.
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