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Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data

 
• By Joseph Haas

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

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Novavax hopes to launch its US Phase III study for its COVID-19 vaccine soon

Despite delays in the start of its US/Mexico Phase III trial of its COVID-19 vaccine candidate, Novavax, Inc. thinks it may be able to file for a US emergency use authorization based on data from its UK pivotal trial of NVX-CoV2373, which it anticipates might be available during the first quarter of 2021. The Maryland biotech also hopes to initiate its US/Mexico study in the next few weeks, after it addresses US Food and Drug Administration questions about producing the vaccine on a commercial scale.

Novavax said on 30 November that its UK trial has completed enrollment of 15,000 patients and should reach the needed number of events to report interim data as soon as...

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