July 24, 2020 -- Novavax and Fujifilm Diosynth have signed an agreement covering the bulk manufacture of Novavax's COVID-19 vaccine candidate, NVX-CoV2373, at Fujifilm's Morrisville, NC, facility.
The large-scale manufacture of the vaccine candidate is part of the $1.6 billion award from the U.S. government's Operation Warp Speed. The award covers late-stage clinical development, including a phase III clinical trial and funds to establish large-scale manufacturing to enable the delivery of 100 million doses of the vaccine as early as late 2020.
Manufactured doses from the Fujifilm North Carolina site will be utilized in the phase III clinical trial of up to 30,000 subjects, which is expected to begin in the fall of 2020.
NVX-CoV2373 is a stable prefusion protein using Novavax's proprietary nanoparticle technology and adjuvant. Fujifilm will provide manufacturing capabilities and baculovirus expression system expertise to help deliver the 100 million doses.