Gaithersburg-based Novavax, a clinical-stage biotech company that develops vaccines to prevent serious infectious diseases, has been awarded $1.6 billion to participate in a U.S. government program aimed at bringing a COVID-19 vaccine to the world.
The 33-year-old company is currently conducting clinical trials for its COVID-19 vaccine while it prepares to produce up to 100 million vaccine doses by the end of the year. This award comes with Novavax’s selection to participate in Operation Warp Speed, a program operated by the federal government which aims to invest in companies prepared to deliver effective COVID-19 vaccines in 2021. The company will use the fresh funding to move its vaccine candidate into the third phase of clinical trials, establish large-scale manufacturing and produce 100 million vaccine doses, as planned.
The company has never brought a product to market before, according to The New York Times.
“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 Novavax President and CEO Stanley C. Erck in a statement. “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.”
As part of the partnership, Novavax must demonstrate that it can scale up manufacturing for its vaccine and transition to ongoing production, per a press release. During this time, the company will also determine whether the vaccine works as intended, and whether it is safe for patients It plans to run trials with up to 30,000 subjects this fall. The federal funding will also support Novavax’s plans to file a license with the U.S. Food and Drug Administration to administer its vaccine.
Back in May, Novavax conducted phase one and two clinical trials of its coronavirus vaccine on 130 healthy participants ages 18 to 59 in Australia. Safety results from these trials are expected to come in this month. These first two vaccine trials were financially supported by Norway’s Coalition for Epidemic Preparedness Innovations, which invested a total of $388 million. Novavax is manufacturing its coronavirus vaccine in Baltimore.
It’s one example of Maryland’s life sciences companies jumping into the fight against COVID-19, armed with years of experience and relationships with others in the region willing to partner.