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Novavax's COVID-19 vaccine for adults over 18 backed by FDA advisors: What's next?

Novavax's COVID-19 vaccine for adults over 18 backed by FDA advisors: What's next?

Novavax 针对 18 岁以上成年人的 COVID-19 疫苗得到美国食品药品管理局顾问的支持:下一步是什么?
Benzinga Real-time News ·  2022/06/08 07:33

$Novavax(NVAX.US)$ announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

$Novavax (NVAX.US) $宣布,美国食品药品监督管理局(FDA)疫苗及相关生物制品咨询委员会(VRBPAC)以21票对0票,一票弃权,建议美国食品药品管理局为18岁及以上的人授予Novavax COVID-19 疫苗(nvx-cov2373)的紧急使用授权(EUA)。

What Happened:  The FDA considers the recommendations of VRBPAC when making decisions on EUA.

发生了什么:美国食品和药物管理局在就EUA做出决定时会考虑VRBPAC的建议。

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Novavax's President and CEO Stanley C. Erck.

Novavax总裁兼首席执行官斯坦利·埃克说:“咨询委员会的积极建议承认了我们的数据实力以及使用创新方法开发的基于蛋白质的 COVID-19 疫苗对传统疫苗技术的重要性。”

"In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

“在今天的VRBPAC会议上,我们听到了医生、医疗保健组织和消费者对我们疫苗的压倒性支持,他们热切期待蛋白质类疫苗的选择。与向全球监管机构提交的文件一致,我们已经向美国食品和药物管理局提交了包含最新制造信息的修正案以供审查。我们期待与FDA合作,做出最终决定。”

If EUA is granted by the FDA, it would be the first protein-based COVID-19 vaccine available in the U.S. According to CNBC, the agency could clear Novavax's vaccine for distribution in the U.S. as soon as this week. 

如果 EUA 获得美国食品药品管理局的批准,它将是美国第一种基于蛋白质的 COVID-19 疫苗。 据CNBC报道,该机构最快可能在本周批准Novavax的疫苗在美国分发。

The Novavax vaccine would become the fourth COVID-19 vaccine authorized in the U.S. if the FDA approves it.

如果美国食品药品管理局批准,Novavax 疫苗将成为美国批准的第四种 COVID-19 疫苗。

Why It Matters: The Novavax COVID-19 vaccine has already received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization. If the EUA is granted by the FDA, the vaccine can be administered in the U.S.

为什么重要: 除了世界卫生组织的紧急用途清单外,Novavax COVID-19 疫苗已经获得授权,可用于来自 40 多个国家的 18 岁及以上人群。如果EUA获得FDA的批准,则该疫苗可以在美国接种。

NVAX Price Action: Novavax shares closed Tuesday up 22.74% at $47.54 a share.

NVAX 价格走势:Novavax股价周二收盘上涨22.74%,至每股47.54美元。

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