Novavax Selected for Operation Warp Speed, Receives USD 1.6 Billion for COVID-19 Vaccine Development

(Gaithersburg, MD, USA) has been selected to participate in Operation Warp Speed (OWS), a US government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021.

Novavax has also been awarded USD 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 NVX‑CoV2373, the company’s COVID-19 vaccine candidate, as early as late 2020. NVX‑CoV2373 is engineered from the genetic sequence of SARS‑CoV‑2 and was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains the company’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020.

Under the terms of the agreement, Novavax will demonstrate that it can rapidly stand 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. The agreement also allows for a follow-on agreement with the US government for additional production and procurement to support OWS’ vaccine production goal. This latest federal funding supports Novavax plans to file submissions for licensure with the US Food and Drug Administration (FDA).

“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,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “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.”

“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,” said U.S. Health and Human Services Secretary Alex Azar. “Today’s USD 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.”

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