After that, it will begin the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction.
The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting the Phase 1/2 clinical trial with up to $388 million in funding.
As part of its agreement for receiving the OWS funding, Novavax must demonstrate that it has the ability to quickly establish large-scale manufacturing and transition into the ongoing production of NVX-CoV2373 if needed.
Operation Warp Speed aims to have COVID-19 vaccines by the end of 2020
In a statement, Novavax President and CEO, 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 honored 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.”
U.S. Health and Human Services (HHS) Secretary, Alex Azar, commented, “Adding Novavax’s 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.”