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EU decision on Novavax COVID-19 shot could come ‘within weeks’ -Breaking

by Mike Robinson

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© Reuters. FILE PHOTO: A girl holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in entrance of displayed Novavax brand on this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

(Reuters) – The European Union’s drug regulator mentioned on Wednesday it might determine on Novavax (NASDAQ:)’s COVID-19 vaccine approval “inside weeks” if the information it has acquired from the drugmaker was adequate to show the shot’s effectiveness.

The protein-based vaccine, branded Nuvaxovid, has been underneath a rolling evaluate since February, the European Medicines Company (EMA) mentioned. Such critiques permit for a speedy approval.

If authorized by the EMA, the shot can be the area’s fifth coronavirus vaccine, becoming a member of these from Pfizer-BioNTech, Moderna (NASDAQ:), AstraZeneca (NASDAQ:) and Johnson & Johnson (NYSE:).

The foremost approval might come a lot forward of authorisation in the US, the place Novavax needed to resolve manufacturing points and expects to file for approval by the tip of the 12 months.

The EMA mentioned two of its advisory panels had been trying into numerous plans submitted by Novavax on threat administration, and improvement and research of the vaccine to be used in kids.

Novavax’s shot acquired its first emergency use approval earlier this month in Indonesia. The corporate has additionally sought backing from the World Well being Group. The Philippines on Wednesday authorised emergency use of a model made by India’s Serum Institute.

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