Novavax (NASDAQ: NVAX) announced that it received $1.6 funding for the development of a vaccine for COVID-19, which continues to spread across the United States and around the world.
In the U.S., 2,932,596 people have been infected by the virus and 130,133 already died as of July 7, according to data from the Centers for Disease Control and Prevention (CDC).
Helping Novavax complete its clinical studies for COVID-19 vaccine candidate
According to the biotechnology company, the funding came from the U.S. government’s Operation Warp Speed (OWS) program that aims to start delivering millions of doses of a safe and effective vaccine for COVID-19 next year.
OWS provided the $1.6 billion funding to help Novavax complete the late-stage clinical studies necessary to determine the efficacy and safety of its COVID-19 vaccine candidate, NVX-CoV2373.
Novavax’s clinical studies include a Phase 3 clinical trial with up to 30,000 subjects starting in the fall of 2020.
In May, the biotechnology company started the Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age in Australia. It is expecting to have the preliminary immunogenicity and safety results by the end of this month.
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.”