Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
GBS, a condition in which the immune system attacks nerve cells, can lead to muscle weakness and, in severe cases, paralysis.The U.S. Food and Drug Administration (FDA) has mandated updates to the safety labeling for Pfizer Inc's (NYSE:PFE) Abrysvo and GSK plc's (NYSE:GSK) Arexvy respiratory syncytial virus (RSV) vaccines.
美国食品药品监督管理局（FDA）已要求更新辉瑞公司（纽约证券交易所代码：PFE）Abrysvo和葛兰素史克公司（纽约证券交易所代码：GSK）Arexvy呼吸道合胞病毒（RSV）疫苗的安全标签。
New warnings in the prescribing information highlight a potential increased risk of Guillain-Barré syndrome (GBS), a rare neurological disorder, within 42 days of vaccination based on findings from a postmarketing observational study.
根据上市后观察性研究的结果，处方信息中的新警告突出表明，在疫苗接种后的42天内，吉兰-巴雷综合征（GBS）（一种罕见的神经系统疾病）的风险可能会增加。
Also Read: Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services
另请阅读：您的医疗费用正在飙升！2023年美国支出达到5万亿美元，肥胖和糖尿病药物、医院服务大幅增加
GBS, a condition in which the immune system attacks nerve cells, can lead to muscle weakness and, in severe cases, paralysis.
吉兰综合征是一种免疫系统攻击神经细胞的疾病，可能导致肌肉无力，在严重的情况下还会导致瘫痪。
According to the FDA, while the evidence suggests an elevated risk, it is insufficient to confirm a definitive causal link between the vaccines and the disorder.
根据美国食品药品管理局的说法，尽管证据表明风险升高，但不足以证实疫苗与该疾病之间存在明确的因果关系。
This determination is based on data from clinical trials, adverse event reports, and an observational study conducted among Medicare beneficiaries aged 65 and older.
该决定基于临床试验、不良事件报告以及对65岁及以上的医疗保险受益人进行的观察性研究的数据。
The study, conducted between May 2023 and July 2024, utilized Medicare claims to identify cases of hospitalized GBS in individuals vaccinated with Abrysvo or Arexvy.
该研究于2023年5月至2024年7月进行，利用医疗保险索赔来确定接种Abrysvo或Arexvy疫苗的人中的吉兰综合征住院病例。
Using a self-controlled case series analysis, researchers compared risk windows of 1-42 days post-vaccination with control windows of 43-90 days. The findings estimate nine excess GBS cases per million doses of Abrysvo and seven per million doses of Arexvy administered to individuals aged 65 and older.
研究人员使用自控病例系列分析，将疫苗接种后1-42天的风险窗口与43-90天的控制窗口进行了比较。研究结果估计，每给65岁及以上人群服用每百万剂Abrysvo中有9例过量GBS病例，每百万剂Arexvy中有7例过量发作。
These risks reflect excess cases compared to background rates of GBS in the studied population. However, variations in background risks and analytical methods make direct comparisons to other studies challenging. The FDA emphasized that while increased risks were observed, further investigation is needed to fully understand the connection between the vaccines and GBS.
与研究人群中 GBS 的背景发病率相比，这些风险反映了过多的病例。但是，背景风险和分析方法的不同使得与其他研究进行直接比较具有挑战性。美国食品和药物管理局强调，尽管观察到风险增加，但需要进一步调查，以充分了解疫苗与吉兰巴综合征之间的关系。
U.S. sales of RSV vaccines have declined after regulators narrowed the age group eligible for the shots and determined they would be a one-time vaccination for now.
在监管机构缩小了有资格接种疫苗的年龄组并确定目前将是一次性疫苗接种之后，美国呼吸道合胞病毒疫苗的销量有所下降。
For Pfizer and GSK, RSV vaccines are critical as they seek to build new revenue streams before facing generic competition for their top-selling drugs.
对于辉瑞和葛兰素史克而言，呼吸道合胞病毒疫苗至关重要，因为他们在面临最畅销药物的仿制药竞争之前寻求建立新的收入来源。
Price Action: GSK stock is down 1.55% at $33.56, and PFE stock is down 0.18% at $27.08 during the premarket session at last check Wednesday.
价格走势：在周三最后一次盘前交易中，葛兰素史克股价下跌1.55％，至33.56美元，PFE股价下跌0.18％，至27.08美元。
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