FDA Approves Pfizer's Respiratory Syncytial Virus Vaccine Abrysvo For Adults Below 60 Years
FDA Approves Pfizer's Respiratory Syncytial Virus Vaccine Abrysvo For Adults Below 60 Years
The FDA's decision is based on inferred efficacy from the pivotal Phase 3 MONeT study, which investigated the safety, tolerability, and immunogenicity of Abrysvo in adults at risk of RSV-associated disease due to certain chronic medical conditions.On Tuesday, the FDA approved Pfizer Inc's (NYSE:PFE) Abrysvo (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 who are at high risk.
星期二，FDA批准了輝瑞公司（紐交所:PFE）Abrysvo（呼吸道合胞病毒疫苗），該公司的二價RSV前融合F(RSVpreF)疫苗，用於預防18至59歲處於高風險人群中的個體因RSV而導致的下呼吸道疾病（LRTD）。
Abrysvo now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.
Abrysvo現在爲成人提供了最廣泛的RSV疫苗適應症，之前包括60歲及以上的人。
Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.
此外，它仍然是唯一被批准用於妊娠32至36周孕齡的人群以保護嬰兒從出生到6個月齡的RSV免疫接種。
The FDA's decision is based on inferred efficacy from the pivotal Phase 3 MONeT study, which investigated the safety, tolerability, and immunogenicity of Abrysvo in adults at risk of RSV-associated disease due to certain chronic medical conditions.
FDA的決定基於關鍵性III期MONet研究推斷的有效性，該研究調查了Abrysvo在因特定慢性醫療條件而面臨RSV相關疾病風險的成人中的安全性，耐受性和免疫原性。
Also Read: Pfizer's Respiratory Syncytial Virus Vaccine Data Shows Promise In Subgroup Of Younger Immunocompromised Patients.
此外閱讀：輝瑞的呼吸道合胞病毒疫苗數據顯示在年輕的免疫受損患者亞組中有希望。
The company intends to submit MONeT results for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference.
該公司打算提交MONet研究結果以發表在同行評審的科學期刊上，並在即將舉行的科學會議上進行報告。
In June, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the routine use of Respiratory Syncytial Virus (RSV) vaccines in all adults aged 75 and above.
六月份，美國疾病控制和預防中心（CDC）的免疫接種實踐諮詢委員會（ACIP）投票建議所有年齡在75歲及以上的成年人定期接種呼吸道合胞病毒（RSV）疫苗。
ACIP postponed a vote on a recommendation for adults aged 50-59 years at increased risk for RSV-LRTD until additional data became available.
ACIP推遲對於處於50至59歲且處於增高RSV-下呼吸道界定疾病風險的成人的免疫接種建議的表決，直到有更多數據可用。
U.S. sales of RSV vaccines from GSK Plc (NYSE:GSK) and Pfizer have declined after regulators narrowed the age group eligible for the shots and determined they would be a one-time vaccination for now.
GSK Plc（NYSE：GSK）和輝瑞公司的RSV疫苗在監管機構縮小符合接種條件的年齡組後銷量下降，並決定目前只能作爲一次性疫苗。
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。
In 2023, an average of 440,000 people per week received RSV vaccines from GSK and Pfizer in September, with 65% opting for GSK's Arexvy. However, this September, the weekly average fell to 157,000.
2023年9月，平均每週有44萬人接種了GSK和輝瑞的RSV疫苗，其中65%選擇了GSK的Arexvy。然而，今年9月，每週平均接種人數下降至157,000人。
Price Action: PFE stock is down 0.36% at $28.74 at last check Wednesday.
價格走勢：輝瑞（PFE）股價最近一次查看，下跌0.36％至28.74美元。
Image via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。
