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

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 and to include “proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities” (DID, Oct. 28).

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. More than 25 percent of the participants are older than 65, with many having underlying conditions making them at higher risk of severe disease progression.

In addition, Novavax is conducting a phase 2b trial in South Africa and has completed enrollment of 4,422 participants, including 245 HIV-positive volunteers.

Novavax is also eyeing a combined influenza/COVID-19 vaccine for post-pandemic use that would combine NVX-CoV2373 and NanoFlu. ― Jason Scott