FUJIFILM Diosynth Biotechnologies to manufacture Novavax COVID-19 vaccine candidate

Novavax and FUJIFILM Diosynth Biotechnologies (FDB) have announced their agreement for the latter to manufacture the bulk drug substance for NVX-CoV2373, the Novavax COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has now begun production of the first batch of NVX-CoV2373.

According to the companies, this arrangement falls under Novavax’s recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a US government programme that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the US population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a Phase III 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’s proprietary nanoparticle technology and includes the company’s Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilised in a future Phase III clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.

“We are grateful to partner with the team at FDB to ensure the large-scale manufacture of our COVID-19 vaccine candidate,” said Stanley Erck, President and Chief Executive Officer of Novavax. “We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.”

“We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax’s response to this global crisis,” said Martin Meeson, Chief Executive Officer of FDB. “As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact.”