Novavax (NASDAQ:NVAX) enters into an agreement with CDMO FUJIFILM Diosynth Biotechnologies for the manufacture of bulk drug substance for NVX-CoV2373, its COVID-19 vaccine candidate.
Production of the first batch is underway at FUJIFILM's Morrisville, NC site which is earmarked for a 30K-subject Phase 3 clinical trial expected to launch in the fall.
Manufacturing costs will be funded under the $1.6B award from the U.S. government's Operation Warp Speed initiative.
Results from a Phase 1 trial in 130 healthy volunteers will be released during the first week of August. The Phase 2 portion will begin shortly thereafter.
