FDA Approves Merck's Pneumococcal Vaccine As First Shot Designed For Adults
FDA Approves Merck's Pneumococcal Vaccine As First Shot Designed For Adults
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for using Capvaxive in adults.Monday, the FDA approved Merck & Co Inc's (NYSE: MRK) Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to protect against 21 strains of bacteria to prevent a severe form of pneumococcal disease.
週一，FDA批准了默沙東公司（紐交所：MRK）的Capvaxive（肺炎球菌21價結合疫苗），用於保護免受21種細菌的感染，以預防嚴重型肺炎球菌病。
It's the first pneumococcal conjugate vaccine specifically designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection.
這是第一個專門設計用於保護成年人免受一種名爲肺炎球菌引起的嚴重疾病和肺部感染的肺炎球菌結合疫苗。
Merck currently has two approved pneumococcal shots:
默沙東目前有兩種獲批的肺炎球菌疫苗:
- Vaxneuvance is given to individuals six weeks or older.
- Pneumovax 23 for adults 50 years and older as well as two-year-olds and above who are at an increased risk of the disease.
- Vaxneuvance適用於6周或以上的個體。
- Pneumovax 23適用於50歲及以上的成年人以及兩歲及以上且有增加患病風險的個體。
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for using Capvaxive in adults.
美國疾病控制與預防中心的預防接種實踐諮詢委員會有望在本月晚些時候舉行會議，討論並推薦成年人使用Capvaxive。
In adults 50 years of age and older, Capvaxive covers the serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) cases, compared to approximately 52% covered by Pfizer Inc's (NYSE:PFE) Prevnar 20 (PCV20), which is allowed in children and adults.
在50歲及以上的成年人中，Capvaxive涵蓋了導致約84％侵襲性肺炎球菌疾病（IPD）病例的血清型，而輝瑞公司（紐交所：PFE）的Prevnar 20（PCV20）涵蓋了約52％的血清型，並允許兒童和成年人使用。
In adults 65 years of age and older, Capvaxive covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20.
在65歲及以上的成年人中，Capvaxive涵蓋了導致約85％侵襲性肺炎球菌疾病（IPD）病例的血清型，而PCV20涵蓋了約51％的血清型。
Capvaxive includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; based on the same CDC data, those serotypes were responsible for approximately 27% of IPD cases in adults 50 years of age and older and approximately 30% in adults 65 years of age and older.
Capvaxive包括其他任何現有肺炎球菌疫苗沒有涵蓋的8種獨特血清型；基於同樣的CDC數據，這些血清型負責50歲及以上成年人約27％的IPD病例以及65歲及以上成年人約30％的IPD病例。
Among the clinical data supporting the approval are results from the pivotal Phase 3 STRIDE-3 trial, which evaluated CAPVAXIVE compared to PCV20 in adults 18 and older who had not previously received a pneumococcal vaccine.
支持批准的臨床數據包括來自關鍵性3期STRIDE-3試驗的結果，該試驗評估了未曾接種肺炎球菌疫苗的18歲及以上成年人和PCV20之間的CAPVAXIVE。
The approval is also supported by results from the Phase 3 STRIDE-5 and STRIDE-6 trials evaluating Capvaxive in vaccine-naïve and vaccine-experienced adults.
支持該批准的還有來自第3期STRIDE-5和STRIDE-6試驗的結果，分別評估Capvaxive在未接種過疫苗和接種過疫苗的成年人中的功效。
Reuters noted that the vaccine has a wholesale acquisition price of $287 per dose. Most individuals will likely have access to it at no out-of-pocket cost if it gets a routine recommendation from the CDC's advisers.
路透社指出，該疫苗的批發採購價格爲每劑287美元。如果CDC的顧問委員會給出常規建議，大多數個體可能無需支付任何費用即可使用該疫苗。
Concurrently, the FDA also approved Merck's Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for primary advanced or recurrent endometrial carcinoma.
同時，FDA還批准了Merck的Keytruda（pembrolizumab）與卡鉑和紫杉醇聯合使用，然後再作爲單一藥物治療晚期或複發性子宮內膜癌。
This approval marks the third endometrial carcinoma indication and the 40th indication overall for Keytruda in the U.S.
此批准標誌着Keytruda在美國的第三種子宮內膜癌適應症以及總共第40種適應症。
The approval is based on data from the Phase 3 NRG-GY018 trial (KEYNOTE-868), in which Keytruda combo regime followed by Keytruda alone reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient and by 70% in patients whose cancer was mismatch repair deficient, compared to placebo with carboplatin and paclitaxel followed by placebo alone.
該批准基於第3期NRG-GY018試驗（KEYNOTE-868）的數據，該試驗中，Keytruda聯合方案後接受Keytruda單獨治療的患者，對於錯配修復 proficient 型癌症患者的疾病進展或死亡風險降低了40％，對於錯配修復 deficient 型癌症患者，這一比例爲70％，而與卡鉑和紫杉醇聯用的安慰劑則爲對照組。
Price Action: MRK shares closed at $127.50 on Monday.
價格行動：週一，MRK股票收於127.50美元。
譯文內容由第三人軟體翻譯。