The federal government’s Operation Warp Speed has made its biggest financing award yet, promising $1.6 billion to a Maryland biotech to help advance its investigational COVID-19 vaccine and ready millions of doses in preparation for its possible success.
Gaithersburg, MD-based Novavax, which has never before brought a product to market, announced the federal award Tuesday. The money is the latest allocation made out of the funds allocated to Operation Warp Speed (OWS), a multiagency effort to assist companies in readying effective COVID-19 vaccines.
Previously Novavax secured commitments from the Coalition for Epidemic Preparedness Innovations and the Department of Defense of up to $388 million and up to $60 million, respectively, to forward development of the candidate, NVX-CoV2373.
A number of techniques are being explored in the hunt for vaccines that can help to slow the pandemic. Novavax’s approach uses nanoparticle technology to deploy microscopic viral proteins, derived from the coronavirus, to prompt an immune response. The protein-based candidate also includes an ingredient, referred to as an adjuvant, that Novavax has developed to boost the body’s response.
Novavax’s most advanced vaccine candidate, a nanoparticle flu vaccine called NanoFlu, was also created using this technology and the adjuvant. Earlier this year the product candidate met the main goals of a Phase 3 clinical trial in older adults.
At the moment Novavax’s COVID-19 vaccine candidate is under evalution in a Phase 1 clinical trial, which kicked off in Australia in May, in 130 heathy volunteers age 18 to 59. Initial data from that trial are expected this month. Depending on those results, the vaccine could start a pivotal trial that would enroll up to 30,000 people this fall.
This new money is slated to get the experimental Novavax (NASDAQ: NVAX) vaccine through clinical testing—including the potential Phase 3 study—and establish manufacturing operations that will allow the company to produce millions of doses—an industrial-scale effort that would typically occur only once efficacy and safety were assured.
Operation Warp Speed, which has set an ambitious goal of delivering 300 million doses of a vaccine that works for COVID-19 by January, is financing manufacturing efforts at Novavax and other companies with promising candidates in development to ensure doses of any that do pan out will be available with minimal delay.
“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,” Alex Azar, the health and human services secretary, said in a prepared statement. The money Novavax is getting will be enough for it to produce 100 million doses, he said.
In being selected for COVID-19 vaccine federal assistance, Novavax joins AstraZeneca (NYSE: AZN), which has been awarded $1.2 billion; Moderna (NASDAQ: MRNA), which has been awarded more than $500 million; Johnson & Johnson (NYSE: JN) unit Janssen, which was awarded about $456 million, Merck and its nonprofit partner IAVI, which were awarded about $38 million; and Sanofi, which received about $30 million.