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.
美國食品藥品監察局（FDA）要求對輝瑞公司的（紐交所：PFE）Abrysvo和GSk plc的（紐交所：GSK）呼吸道合胞病毒（RSV）疫苗的安全標籤進行更新。
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.
處方信息中的新警告強調了在接種疫苗後42天內增加吉蘭-巴雷綜合徵（GBS）風險的可能性，這是一種罕見的神經系統疾病，基於一項上市後觀察研究的發現。
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！美國在2023年的支出達到了5萬億，肥胖和糖尿病藥物及醫院服務顯著增加。
GBS, a condition in which the immune system attacks nerve cells, can lead to muscle weakness and, in severe cases, paralysis.
GBS是一種免疫系統攻擊神經細胞的控制項，可能導致肌肉無力，嚴重時可能導致癱瘓。
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FDA的說法，儘管證據表明風險上升，但不足以確認疫苗與該控制項之間的確切因果關係。
This determination is based on data from clinical trials, adverse event reports, and an observational study conducted among Medicare beneficiaries aged 65 and older.
這一決定基於臨牀試驗、不良事件報告以及對65歲及以上醫療保險受益者進行的觀察研究的數據。
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月間進行，利用醫療保險報銷數據識別接種Abrysvo或Arexvy後住院的GBS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.
使用自我對照病例系列分析，研究人員比較了接種疫苗後1-42天的風險窗口與43-90天的對照窗口。研究結果估計，在接種給65歲及以上個體的Abrysvo每百萬劑次中有九例額外的GBS病例，以及在接種Arexvy每百萬劑次中有七例。
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.
這些風險反映了與研究人群背景下GBS發生率相比的過量病例。然而，背景風險和分析方法的變化使得與其他研究的直接比較變得具有挑戰性。FDA強調，儘管觀察到了增加的風險，但需要進一步調查以全面理解疫苗與GBS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.
美國RSV疫苗的銷售在監管機構縮小了適用年齡組並確定這將是一次性接種的情況下有所下降。
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GSK來說，RSV疫苗至關重要，因爲他們希望在他們的暢銷藥面臨仿製競爭之前建立新的營業收入渠道。
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.
價格動態：GSk股票在最新的盤前交易中下跌1.55%，報33.56美元，而PFE股票下跌0.18%，報27.08美元。
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譯文內容由第三人軟體翻譯。
