巴伐利亚北欧向欧盟监管机构提交了有关青少年Mpox疫苗扩展的数据. Bavarian Nordic submits data to EU regulator for adolescent Mpox vaccine extension.
丹麦生物技术公司巴伐利亚北欧公司已向欧盟药物监管机构提交数据,以获得批准,扩大其Mpox疫苗 (JYNNEOS,也称为IMVANEX) 对12-17岁青少年的使用. Danish biotech company Bavarian Nordic has submitted data to the European Union's drug regulator for approval to extend the use of its Mpox vaccine (JYNNEOS, also known as IMVANEX) for adolescents aged 12-17. 目前,该疫苗被批准用于18岁及18岁以上的成年人。 The vaccine is currently approved for use in adults aged 18 and over. 首席执行官保罗·查普林指出,扩大对青少年的批准范围对于应对主要影响青少年和幼儿的疫情至关重要。 CEO Paul Chaplin stated that the expanded approval for teenagers would be crucial in tackling the outbreak, which primarily affects adolescents and young children. 世界卫生组织宣布,非洲天花疫情升级是公共卫生紧急情况,今年报告病例超过15 000例,至少死亡537人。 The World Health Organization declared an escalating Mpox outbreak in Africa as a public health emergency, with more than 15,000 cases and at least 537 deaths reported this year. 巴伐利亚北欧计划今年晚些时候在刚果民主共和国和乌干达对2至12岁儿童的疫苗进行研究。 Bavarian Nordic plans to conduct a study of the vaccine in children aged 2 to 12 years old in the Democratic Republic of the Congo and Uganda later this year.