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60岁及以上人群有望迎首个呼吸道合胞病毒疫苗
Bei Ke Cai Jing· 2026-02-12 04:38
Core Viewpoint - GlaxoSmithKline (GSK) has submitted a marketing application for its respiratory syncytial virus (RSV) vaccine for adults aged 60 and above, which, if approved, will be the first vaccine authorized by the National Medical Products Administration (NMPA) in China for this demographic to prevent RSV-related lower respiratory diseases [1][2]. Group 1: Vaccine Application and Approval - The NMPA has accepted GSK's application for the RSV vaccine, which targets adults aged 60 and above [1]. - If approved, this vaccine will be the first of its kind in China to help prevent the potential consequences of RSV in older adults [1]. Group 2: RSV Impact and Statistics - RSV is a common and contagious virus that affects approximately 64 million people globally each year, with older adults facing higher risks due to chronic diseases and age [1]. - In China, over 6 million individuals aged 60 and above are affected by RSV annually, leading to more than 350,000 related hospitalizations [1]. Group 3: Clinical Trial Results - The data submitted for the marketing application includes positive results from a Phase III clinical trial assessing the vaccine's safety and immunogenicity in adults aged 60 and above in China [2]. - All primary endpoints of the clinical trial were met, and the safety data of the vaccine aligns with expectations [2]. - The regulatory authority is expected to make a decision on the application next year [2].
葛兰素史克重组呼吸道合胞病毒疫苗新适应症的上市申请获受理
Zheng Quan Ri Bao· 2026-02-11 05:40
Core Viewpoint - GlaxoSmithKline (GSK) has announced that the China National Medical Products Administration (NMPA) has accepted its application for the marketing of a recombinant respiratory syncytial virus (RSV) vaccine, aimed at preventing lower respiratory tract diseases caused by RSV in adults aged 60 and above [1] Group 1: Vaccine Approval and Market Potential - The RSV vaccine, if approved, will be the first in China to help adults aged 60 and above prevent the severe consequences of RSV [1] - The vaccine has already been approved in over 65 countries for the prevention of lower respiratory tract diseases caused by RSV in the same age group [1] Group 2: Disease Impact and Statistics - RSV is a common and contagious virus that can lead to lung and respiratory infections, affecting approximately 64 million people globally each year [1] - In China, over 6 million individuals aged 60 and above are affected by RSV annually, resulting in more than 350,000 related hospitalizations [1]