点击显示 收起
丹麦Bavarian Nordic公司8月7日宣布，天花疫苗Imvanex(MVA-BN)上市审批申请(MAA)已获得了欧盟委员会(EC)的批准，用于一般成人群体(包括免疫力低下群体，如HIV患者和过敏性皮炎患者)的主动免疫，预防天花(smallpox)。该项批准，涵盖了所有27个欧盟成员国和欧洲经济区国家冰岛、列支敦士登和挪威。
这是首个获欧盟批准、通过与美国政府之间成功的公-私伙伴关系开发的一种新颖的生物防御疫苗。
Imvanex是唯一一个通过欧盟集中审批程序获批的天花疫苗，该疫苗在美国名为Imvamune，通过与美国政府合作开发。自2010年以来，Bavarian Nordic一直在向美国国家战略储备(US Strategic National Stockpile)供货，用于免疫系统受损患者(如特异性皮炎患者及HIV患者)的紧急使用。
英文原文：Bavarian Nordic smallpox vaccine cleared in EU
Article | 08 August 2013
The European Commission has granted marketing authorization for Denmark-based Bavarian Nordic’ (OMX: BAVA) Imvanex (MVA-BN) for active immunization against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis).
This is the first European approval of a novel biodefense vaccine developed through a successful public-private partnership with the US government, the company noted.
“The marketing authorization of Imvanex marks a significant milestone for our company and our MVA-BN vaccine technology platform, which now serves as the foundation for multiple candidates in our development pipeline,” said Anders Hedegaard, president and chief executive of Bavarian Nordic, adding: “We are delighted to receive our first regulatory product approval, which was supported by a strong partnership with the US government and proves that public-private enterprises can work if there is a shared vision and willingness to invest in a sustained biodefense market.”
Imvanex is the only smallpox vaccine approved through the centralized European Union procedure. Known as Imvamune in the USA, it has been developed under contracts with the US government. Since 2010, Bavarian Nordic has been delivering the vaccine to the US Strategic National Stockpile for emergency use in immune compromised individuals, such as people with atopic dermatitis and HIV who are not has also been supplied to other government stockpiles around the world.