On Jul. 23, 2020, Novavax and FUJIFILM Diosynth Biotechnologies announced an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax COVID-19 vaccine candidate. FDBﾒs site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

This arrangement fell under Novavax’ $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding was being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020.

NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina were utilized in a pivotal Phase 3 clinical trial of up to 30,000 subjects which was expected to begin in the fall of 2020 and which determined the safety and efficacy of NVX-CoV2373.