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Novavax COVID-19 vaccine could get EU approval next week


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

(Reuters) -Novavax’s COVID-19 vaccine could obtain approval from Europe’s drug regulator next week and subsequently an emergency use itemizing from the World Health Organization, the Financial Times reported on Thursday, sending shares of the U.S. drugmaker up 7%.

A WHO approval could come as soon as the well being physique issued its personal emergency use itemizing or if the EMA gave it a conditional advertising and marketing authorization, the newspaper reported https://www.ft.com/content material/a938950e-7f97-46d6-a22c-6933c5634842, citing individuals aware of the matter.

That could pave the way in which for the corporate and its companion, Serum Institute of India, to ship doses to the COVAX program, offering one other vaccine to low-income international locations.

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The WHO mentioned on Thursday that it could reveal its place over the vaccine within the coming days, following an knowledgeable group assembly.

The protein-based vaccine by Novavax (NASDAQ:) in June was proven to be greater than 90% efficient, together with in opposition to a wide range of regarding coronavirus variants, in a big, late-stage U.S. trial.

Novavax’s shot obtained its first authorization in Indonesia final month and is awaiting approval in Japan, the place it could be manufactured and distributed by Takeda Pharmaceutical.

The Maryland-based firm has additionally mentioned https://www.reuters.com/enterprise/healthcare-pharmaceuticals/novavax-says-it-could-start-making-omicron-specific-vaccine-january-2021-12-02 it could start business manufacturing of a vaccine tailor-made to the extremely transmissible Omicron coronavirus variant in January.

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The drugmaker is at present testing the effectiveness of its current two-dose vaccine in opposition to Omicron.

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