Novavax inks $1.6B Warp Speed deal to fund COVID vaccine's phase 3 testing, manufacturing

Novavax and its COVID-19 shot are racing against well-funded global pharmaceutical players, but a new deal with the U.S. government will push the biotech's fundraising haul past $2 billion. 

The Maryland biotech on Tuesday unveiled a $1.6 billion deal with Operation Warp Speed—the project's largest funding commitment so far—to support late-stage vaccine testing and manufacturing. For Novavax, the agreement follows others with the Coalition for Epidemic Preparedness Innovations and the U.S. government worth more than $400 million.

Novavax's candidate, which combines an antigen generated from the virus' spike protein and the company's proprietary Matrix-M adjuvant, is already in phase 1/2 testing, and the biotech expects to report early data this month. If the data are promising, the company will move to the phase 2 portion of the study, where investigators will look at immunity, safety and disease reduction. The phase 3 efficacy study would enroll up to 30,000 participants and begin in the fall.

The company has never brought a product to market, but it's also advancing a late-stage flu vaccine candidate with plans to file for FDA approval soon.

Meanwhile, Novavax also plans to use Warp Speed funds to ramp up COVID-19 vaccine manufacturing. The company has pledged to produce 100 million vaccine doses this year, and the partners could sign an add-on deal for more doses.  

The U.S. government's Operation Warp Speed aims to deliver 300 million doses of safe and effective COVID-19 vaccines by January 2021.

News of Novavax's Warp Speed deal comes after a June New York Times report that cited five companies as finalists in the program; that group didn't include Novavax.

RELATED: Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work 

Now, the company has scored Warp Speed’s largest financial commitment to date, besting AstraZeneca’s $1.2 billion deal and other contracts with Moderna and Johnson & Johnson worth hundreds of millions of dollars.

Novavax's early- and mid-stage research is supported by a deal worth up to $388 million from CEPI, the Coalition for Epidemic Preparedness Innovations. Novavax also scored a $60 million contract from the U.S. Department of Defense, under which it has pledged to deliver 10 million doses this year. 

RELATED: Novavax, advancing COVID-19 shot, recruits AstraZeneca exec as its chief medical officer 

Meanwhile, the company has been adding to its management team to prep for a leap into commercial supply. In recent weeks, the company brought in Ben Machielse to lead manufacturing and Filip Dubovsky as chief medical officer, among other executive and board additions. And in another step to add capacity, the company last month enlisted Japan’s AGC Biologics to produce its adjuvant.