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Mpox Vaccine Maker Bavarian Nordic Targets Broader Access With European Submission For Imvanex Adolescent Use During WHO Emergency

Mpox Vaccine Maker Bavarian Nordic Targets Broader Access With European Submission For Imvanex Adolescent Use During WHO Emergency

生物-疫苗制造商挪迪克(Bavarian Nordic) 意在通过提交欧洲Imvanex青少年使用申请,为更广泛的人群提供疫苗,在世界卫生组织紧急状态期间使用。
Benzinga ·  08/16 10:43
Bavarian Nordic A/S (OTC:BVNRY) (OTC:BVNKF) submitted clinical data on Thursday to the European Medicines Agency (EMA) to support the extension of the Imvanex (MVA-BN) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.
挪迪克(Bavarian Nordic A/S)向欧洲药品管理局(EMA)提交了临床数据以支持将Imvanex(MVA-BN)天花和m痘疫苗适应症扩展至12至17岁的青少年。
Jynneos is known internationally as Imvamune or Imvanex.
Jynneos在国际上被称为Imvamune或Imvanex。
While currently only indicated for adults 18 years and older, the FDA granted an Emergency Use Authorization for pre- and post-exposure use in adolescents during the 2022 global pox outbreak.
虽然目前只被用于18岁及以上人群,但FDA在2022年全球痘疫爆发期间授予 adolescent 急诊使用授权。
It remains the only FDA and EMA-approved pox vaccine.
它仍然是唯一获得FDA和EMA批准的痘疫苗。
The submission is based on interim results from a clinical study sponsored by...
提交是基于由美国国家卫生研...
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