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?
$Novavax(NVAX.US)$ 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.
$ 諾瓦克斯（NVAX.US）$美國食品和藥物管理局（FDA）疫苗和相關生物產品諮詢委員會（VRBPAC）宣布，以一次棄權投 21 對 0，建議 FDA 授予針對 18 歲及以上個人的諾瓦克 COVID-19 疫苗（NVX-CoV2373）的緊急使用授權（EUA）。
What Happened: The FDA considers the recommendations of VRBPAC when making decisions on EUA.
發生了什麼事：美國食品和藥物管理局在做出決定時考慮 VRBPAC 的建議。
"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 總裁兼首席執行官 Stanley C· 埃克（Stanley C. Erck）表示：「諮詢委員會的積極建議認可我們的數據的強度以及基於蛋白質的 COVID-19 疫苗的重要性，使用傳統疫苗技術開發的創新方法。
"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 會議中，我們聽到了熱切期待基於蛋白質的疫苗選擇的醫生，醫療保健組織和消費者對我們疫苗的壓倒性支持。與向全球監管機構提交的意見一致，我們已向 FDA 提交了一項修正案，其中包含更新的製造資訊，以供美國食品和藥物管理局審查。我們期待與 FDA 合作，因為它做出最終決定。」
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.
如果美國食品藥物管理局（FDA）批准了美國第一種基於蛋白質的 COVID-19 疫苗。 根據 CNBC 的數據，該機構可以在本週清除諾瓦克斯的疫苗，以便在美國分發。
The Novavax vaccine would become the fourth COVID-19 vaccine authorized in the U.S. if the FDA approves it.
如果 FDA 批准，諾瓦克斯疫苗將成為美國授權的第四種 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.
為什麼它很重要： 除了世界衛生組織的緊急用途清單外，Novavax COVID-19 疫苗已獲得授權，可用於來自 40 多個國家/地區的 18 歲及以上的個人。如果美國美國食品和藥物管理局批准, 疫苗可以在美國給藥.
NVAX Price Action: Novavax shares closed Tuesday up 22.74% at $47.54 a share.
NVAX 價格行動：諾瓦克斯股份週二收盤上漲 22.74％，每股 4.54 美元。