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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...

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