Novavax has joined forces with FUJIFILM Diosynth Biotechnologies (FDB), a contract development and manufacturing organisation (CDMO), to produce bulk drug substance for its Covid-19 vaccine candidate NVX-CoV2373.

The US-based vaccine development company has started manufacturing the first batch of its NVX-CoV2373 at FDB’s manufacturing facility in Morrisville, North Carolina.

The batches produced at the North Carolina site will be used in a future Phase 3 clinical trial, evaluating the safety and efficacy of NVX-CoV2373 in up to 300 subjects, and is expected to start by the end of 2020.

Novavax president and chief executive officer Stanley C Erck said: “We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate. We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.”

FUJIFILM Diosynth Biotechnologies chief executive officer Martin Meeson said: “We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax’ response to this global crisis. As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact.”

Novavax received $1.6bn grant under Operation Warp Speed (OWS) initiative

NVX-CoV2373 is a vaccine candidate developed from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19 disease, using the company’s recombinant nanoparticle technology.

The technology generates antigen derived from the coronavirus spike (S) protein and comprises the company’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies.

Novavax will fund the manufacturing costs through the recent $1.6bn grant it has received under the US federal government’s Operation Warp Speed (OWS) initiative, aimed at delivering safe and effective Covid-19 vaccine to the US citizens.

The company is using the OWS funding to complete late-stage clinical development, including a Phase 3 clinical trial, established large-scale manufacturing, and deliver 100 million doses of its potential Covid-19 vaccine starting from late 2020.

Under the development programme, Novavax has initiated a Phase 1 clinical trial in May 2020, with preliminary immunogenicity and safety results expected in the first week of August 2020.

Also, the company has begun a Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy subjects aged between 18 and 59 years, in Australia in May 2020. The trial is supported by $388m funding from the Coalition for Epidemic Preparedness Innovations (CEPI).