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.
美國食品藥品監督管理局（FDA）已要求更新輝瑞公司（紐約證券交易所代碼：PFE）Abrysvo和葛蘭素史克公司（紐約證券交易所代碼：GSK）Arexvy呼吸道合胞病毒（RSV）疫苗的安全標籤。
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.
根據上市後觀察性研究的結果，處方信息中的新警告突出表明，在疫苗接種後的42天內，吉蘭-巴雷綜合徵（GBS）（一種罕見的神經系統疾病）的風險可能會增加。
Also Read: Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services
另請閱讀：您的醫療費用正在飆升！2023年美國支出達到5萬億美元，肥胖和糖尿病藥物、醫院服務大幅增加
GBS, a condition in which the immune system attacks nerve cells, can lead to muscle weakness and, in severe cases, paralysis.
吉蘭綜合徵是一種免疫系統攻擊神經細胞的疾病，可能導致肌肉無力，在嚴重的情況下還會導致癱瘓。
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.
根據美國食品藥品管理局的說法，儘管證據表明風險升高，但不足以證實疫苗與該疾病之間存在明確的因果關係。
This determination is based on data from clinical trials, adverse event reports, and an observational study conducted among Medicare beneficiaries aged 65 and older.
該決定基於臨牀試驗、不良事件報告以及對65歲及以上的醫療保險受益人進行的觀察性研究的數據。
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.
該研究於2023年5月至2024年7月進行，利用醫療保險索賠來確定接種Abrysvo或Arexvy疫苗的人中的吉蘭綜合徵住院病例。
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.
研究人員使用自控病例系列分析，將疫苗接種後1-42天的風險窗口與43-90天的控制窗口進行了比較。研究結果估計，每給65歲及以上人群服用每百萬劑Abrysvo中有9例過量GBS病例，每百萬劑Arexvy中有7例過量發作。
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.
與研究人群中 GBS 的背景發病率相比，這些風險反映了過多的病例。但是，背景風險和分析方法的不同使得與其他研究進行直接比較具有挑戰性。美國食品和藥物管理局強調，儘管觀察到風險增加，但需要進一步調查，以充分了解疫苗與吉蘭巴綜合徵之間的關係。
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.
在監管機構縮小了有資格接種疫苗的年齡組並確定目前將是一次性疫苗接種之後，美國呼吸道合胞病毒疫苗的銷量有所下降。
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.
對於輝瑞和葛蘭素史克而言，呼吸道合胞病毒疫苗至關重要，因爲他們在面臨最暢銷藥物的仿製藥競爭之前尋求建立新的收入來源。
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.
價格走勢：在週三最後一次盤前交易中，葛蘭素史克股價下跌1.55％，至33.56美元，PFE股價下跌0.18％，至27.08美元。
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