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Novavax Expects Late-Stage U.S./Mexico COVID-19 Vaccine Trial to Start Within Weeks

December 1, 2020

Novavax said it will begin a delayed phase 3 trial in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, “in the coming weeks” and that its 15,000-person late-stage trial in the UK is now fully enrolled.

The company originally anticipated a mid-October start date for the North American trial but hit delays in securing enough vaccine doses. The new study aims to enroll up to 30,000 participants.

Maryland-based Novavax has teamed up with Japan’s Fujifilm to manufacture the doses at its plant in Morrisville, N.C.

Novavax hopes to have interim data from the UK phase 3 trial in early 2021 and plans to use that data as the basis for regulatory approval in the EU and the UK.

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