GAITHERSBURG, Md.—Novavax, Inc. announced today that the company has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to deliver millions of doses of a safe, effective vaccine for COVID-19, beginning in 2021.
OWS is facilitating the development, manufacturing and distribution of COVID-19 countermeasures between components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention; the Food and Drug Administration (FDA); the National Institutes of Health; the Biomedical Advanced Research and Development Authority (BARDA); and the Department of Defense (DoD). OWS is coordinating existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development and work by BARDA.
“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,” said Stanley C. Erck, president and chief executive officer of Novavax. “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. We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis.”
Novavax was awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373, as early as late 2020. NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology, and includes Novavax’s proprietary Matrix‑M adjuvant.
NVX‑CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. Novavax’s patented, saponin-based Matrix-M adjuvant has reportedly demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Under the terms of the agreement, Novavax will demonstrate that the company can rapidly ramp up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. 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.
“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,” added Alex Azar, secretary of HHS.
This funding supports Novavax’s plans to file submissions for licensure with the FDA. The agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support the goals that OWS has for vaccine production.
In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of the spike protein to receptors targeted by the virus. A Phase 1 clinical trial of NVX‑CoV2373 was initiated in May, with preliminary immunogenicity and safety results expected by the end of July. The Coalition for Epidemic Preparedness Innovations is investing up to $388 million, and the DoD is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.