The funding will support the late-stage clinical development, including pivotal Phase 3 clinical trial to support licensure and large-scale manufacturing of NVX-CoV2373
Novavax selected for Operation Warp Speed.. (Credit: Pete Linforth from Pixabay.)
Novavax has been selected for Operation Warp Speed (OWS), a US government programme aimed at delivering millions of safe and effective Covid-19 vaccine doses in 2021.
The biotechnology company has been awarded $1.6bn by the US federal government to complete the late-stage clinical development, including a Phase 3 clinical trial, along with large-scale manufacture and delivery of 100 million doses of the company’s Covid-19 vaccine candidate NVX‑CoV2373.
NVX‑CoV2373 has been developed from the genetic sequence of SARS‑CoV‑2, was designed using the company’s recombinant nanoparticle technology and contains its patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies.
Novavax president and chief executive officer Stanley Erck said: “The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together.
“We are honoured to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population.
“We are grateful to the US government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis.”
Novavax evaluated the safety and efficacy of NVX-CoV2373 in a Phase 3 clinical trial
Under the terms of the agreement, Novavax will rapidly begin large-scale manufacturing and distributing large quantities of NVX-CoV2373.
The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.
The latest federal funding will support the company’s efforts to file submissions for licensure with the US Food and Drug Administration (FDA).
In a Phase 1/2 clinical study of NVX-CoV2373 that enrolled 130 healthy participants, is supported by an up-to $388m funding with the Coalition for Epidemic Preparedness Innovations (CEPI).
Operation Warp Speed facilitates the development, manufacturing, and distribution of Covid-19 countermeasures, between components of Department of Health and Human Services (HHS).
US Health and Human Services Secretary Alex Azar said: “Adding Novavax’ candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year.
“Today’s $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people.”