美国食品药品监督管理局（FDA）已批准Moderna公司开发的mFlusiva疫苗，这是首款采用mRNA技术的流感疫苗[1][2]。该疫苗使用的mRNA平台技术与Moderna新冠疫苗相同[2]，适用于50岁及以上的成年人[1][2]。
在临床试验中，该疫苗在50-64岁人群中相比现有流感疫苗的预防效能提高约27%[1]。这项数据基于涉及40000人的研究[1]。主要不良反应包括注射部位疼痛、发热、头痛、疲劳和肌肉酸痛，发生频率略高于现有流感疫苗[1]。FDA对65岁及以上人群采用了加速批准程序[1]。
mFlusiva疫苗由总部位于马萨诸塞州剑桥市的Moderna公司生产[1]，预计很快将在部分零售商处供应[1][2]。
The U.S. Food and Drug Administration has approved mFlusiva, Moderna's first messenger RNA flu vaccine, marking a significant shift in influenza immunization technology [1][2]. The vaccine is designed for adults aged 50 and older, with full approval granted for those between 50 and 64 years old and accelerated approval for those 65 and above [1].
In clinical trials involving 40,000 participants in the 50-64 age group, mFlusiva demonstrated approximately 27% greater effectiveness at preventing flu cases compared to existing flu vaccines [1]. The vaccine uses the same mRNA platform technology that Moderna developed for its COVID-19 vaccine [2]. The most commonly reported side effects include injection site pain, fever, headache, fatigue, and muscle aches, occurring at slightly higher rates than conventional flu vaccines [1].
The vaccine is expected to become available at select retail locations shortly following the FDA's approval announcement [1][2]. Moderna, headquartered in Cambridge, Massachusetts, manufactures the vaccine [1].