CEPI Extends Collaboration With Novavax To Advance Development and Manufacture of COVID-19 Vaccine

CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will invest up to an additional US $384 million to accelerate the development and manufacture of Novavax Inc’s. (NASDAQ: NVAX) NVX-CoV2373 vaccine candidate against COVID-19. Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. This brings CEPI’s total investment in Novavax to up to US $388 million and its total investment in COVID-19 vaccine research & development to up to US $446 million.

CEPI’s expanded investment in Novavax will fund preclinical studies and phase 1 and phase 2 clinical trials. A phase 1 clinical trial will begin this month in Australia, followed by phase 2 clinical trials in multiple countries. If these are successful CEPI anticipates supporting any further clinical development needed to take NVX-CoV2373 through to licensure.

CEPI’s investment will also fund the transfer of NVX-CoV2373 technology to manufacturing partners in different geographical regions around the world, for large-scale production of vaccine. Additionally, funding will enable large-scale production of Novavax’ saponin-based Matrix-M™ adjuvant in Novavax’ manufacturing facility in Uppsala, Sweden, and a second production site to be determined. CEPI’s additional funding will allow Novavax to begin manufacture of millions of doses by the end of 2020 with the goal of escalating large-scale production in 2021.

CEPI and Novavax agree on the importance of global equitable access to vaccines produced out of our partnership. Under the terms of the agreement it is anticipated that vaccines will be procured and allocated through global mechanisms now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative  launched by the WHO and global leaders last month.

The NVX-CoV2373 vaccine candidate

In March 2020, CEPI made an initial investment of $4 million in Novavax to use their recombinant protein nanoparticle technology to develop a vaccine candidate against COVID-19.

In early April 2020, Novavax announced that they had identified a coronavirus vaccine candidate, NVX-CoV2373—a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. Novavax plans to use its proprietary Matrix-M™ adjuvant with NVX-CoV2373 to enhance immune responses. Preclinical studies have shown that NVX-CoV2373 induced robust neutralising antibody responses.

“The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date. Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale. In response to this global pandemic we’re having to be innovative in the way we approach vaccine development and manufacturing. We need to make progress on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay. We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible." - Dr. Richard Hatchett, Chief Executive Officer, CEPI.

“CEPI’s investment in Novavax is critical to our ability to move quickly to advance this promising vaccine candidate as well as to prepare for the delivery of the millions of doses needed globally. We are humbled by their confidence in our science and committed to deliver on behalf of the global community." - Stanley C. Erck, President and CEO of Novavax.