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6-K: Gsk Presents Positive Data for Arexvy, Its Respiratory Syncytial Virus (Rsv) Vaccine, Indicating Protection over Three Rsv Seasons

6-K: Gsk Presents Positive Data for Arexvy, Its Respiratory Syncytial Virus (Rsv) Vaccine, Indicating Protection over Three Rsv Seasons

6-K：GSK提供积极的数据对于Arexvy，其呼吸道合胞病毒（RSV）疫苗，表示在三个RSV季节内提供保护
美股SEC公告 ·  2024/10/08 21:26

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GSK announced new phase III trial data showing Arexvy, its RSV vaccine, demonstrated cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD over three full RSV seasons in adults aged 60 and older. In the third season specifically, the vaccine maintained 48.0% efficacy against RSV-LRTD. The data includes protection across different RSV subtypes and in high-risk populations.The safety and reactogenicity profile remained consistent with previous results, with common side effects including injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination. Arexvy is currently approved in 50 countries for adults 60 and older, and in the US and EU for at-risk individuals aged 50-59.RSV affects an estimated 64 million people globally annually, causing over 465,000 hospitalizations and 33,000 deaths in adults aged 60+ in high-income countries. GSK will continue providing long-term data to help health authorities determine future revaccination schedules, as protection levels are expected to require boosters over time.
GSK announced new phase III trial data showing Arexvy, its RSV vaccine, demonstrated cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD over three full RSV seasons in adults aged 60 and older. In the third season specifically, the vaccine maintained 48.0% efficacy against RSV-LRTD. The data includes protection across different RSV subtypes and in high-risk populations.The safety and reactogenicity profile remained consistent with previous results, with common side effects including injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination. Arexvy is currently approved in 50 countries for adults 60 and older, and in the US and EU for at-risk individuals aged 50-59.RSV affects an estimated 64 million people globally annually, causing over 465,000 hospitalizations and 33,000 deaths in adults aged 60+ in high-income countries. GSK will continue providing long-term data to help health authorities determine future revaccination schedules, as protection levels are expected to require boosters over time.
GSk公布了新的第三阶段试验数据，显示其RSV生物-疫苗Arexvy在60岁及以上成年人中对RSV-LRTD的累积有效性为62.9%，对严重RSV-LRTD的有效性为67.4%，这一数据覆盖了三个完整的RSV季节。在第三个季节中特殊情况下，该疫苗对RSV-LRTD保持了48.0%的有效性。数据包括对不同RSV亚型和高风险人群的保护。安全性和反应性特征与之前结果一致，常见副作用包括接种部位疼痛、疲劳、肌肉疼痛、头痛和关节痛，这些症状通常在接种疫苗后的四天内出现。Arexvy目前已在50个国家获得批准，适用于60岁及以上的成年人，以及在美国和欧盟针对50-59岁的高风险个体。RSV每年影响全球约6400万人，导致高收入国家60岁以上成年人中超过465,000人住院和33,000人死亡。GSk将继续提供长期数据，帮助卫生机构判断未来的再接种时间表，因为预计保护水平需要随着时间进行加强。
GSk公布了新的第三阶段试验数据，显示其RSV生物-疫苗Arexvy在60岁及以上成年人中对RSV-LRTD的累积有效性为62.9%，对严重RSV-LRTD的有效性为67.4%，这一数据覆盖了三个完整的RSV季节。在第三个季节中特殊情况下，该疫苗对RSV-LRTD保持了48.0%的有效性。数据包括对不同RSV亚型和高风险人群的保护。安全性和反应性特征与之前结果一致，常见副作用包括接种部位疼痛、疲劳、肌肉疼痛、头痛和关节痛，这些症状通常在接种疫苗后的四天内出现。Arexvy目前已在50个国家获得批准，适用于60岁及以上的成年人，以及在美国和欧盟针对50-59岁的高风险个体。RSV每年影响全球约6400万人，导致高收入国家60岁以上成年人中超过465,000人住院和33,000人死亡。GSk将继续提供长期数据，帮助卫生机构判断未来的再接种时间表，因为预计保护水平需要随着时间进行加强。
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