Bavarian Nordic seeks EU approval to extend mpox vaccine to adolescents
Adds background in paragraph 3 and 8, detail on trial in children in paragraph 7
COPENHAGEN, Aug 16 (Reuters) -Danish biotech Bavarian Nordic BAVA.CO said on Friday it had submitted data to the European Union's drug regulator for approval to extend the use of the company's mpox and smallpox vaccine to adolescents aged 12 to 17 years.
Mpox has been declared a global public health emergency by the World Health Organization, with children and adolescents being particularly vulnerable to the disease.
Global health officials on Thursday confirmed an infection with a new strain of the mpox virus in Sweden and linked it to a growing outbreak in Africa, in a sign it has started to spread outside the continent.
"Children and adolescents are disproportionally affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population," Bavarian CEO Paul Chaplin said in a statement.
Following the European Medicines Agency' review, the vaccine's marketing authorisation could be extended to include adolescents during the fourth quarter, the company said.
It is also preparing to conduct a clinical trial to assess the vaccine's safety in children aged 2-12 years, potentially extending its use further.
The trial, partially funded by the Coalition for Epidemic Preparedness Innovations, is scheduled to start in the Democratic Republic of Congo and Uganda later this year, Bavarian said.
There have been 27,000 cases and more than 1,100 deaths, mainly among children, in Congo since the current outbreak began in January 2023.
Reporting by Stine Jacobsen, editing by Terje Solsvik and Christina Fincher
免責聲明: XM Group提供線上交易平台的登入和執行服務，允許個人查看和/或使用網站所提供的內容，但不進行任何更改或擴展其服務和訪問權限，並受以下條款與條例約束：（i）條款與條例；（ii）風險提示；（iii）完全免責聲明。網站內部所提供的所有資訊，僅限於一般資訊用途。請注意，我們所有的線上交易平台內容並不構成，也不被視為進入金融市場交易的邀約或邀請 。金融市場交易會對您的投資帶來重大風險。
所有缐上交易平台所發佈的資料，僅適用於教育/資訊類用途，不包含也不應被視爲適用於金融、投資稅或交易相關諮詢和建議，或是交易價格紀錄，或是任何金融商品或非應邀途徑的金融相關優惠的交易邀約或邀請。
本網站的所有XM和第三方所提供的内容，包括意見、新聞、研究、分析、價格其他資訊和第三方網站鏈接，皆爲‘按原狀’，並作爲一般市場評論所提供，而非投資建議。請理解和接受，所有被歸類為投資研究範圍的相關内容，並非爲了促進投資研究獨立性，而根據法律要求所編寫，而是被視爲符合營銷傳播相關法律與法規所編寫的内容。請確保您已詳讀並完全理解我們的非獨立投資研究提示和風險提示資訊，相關詳情請點擊 這裡查看。
