Editor’s Note: This story first appeared in the Washington Business Journal. It appears here in an abbreviated format. See the original post here.
Novavax Inc. just got a significant investment to advance its Covid-19 vaccine candidate.
The Oslo, Norway-based Coalition for Epidemic Preparedness Innovations, a foundation that invests in vaccine development for emerging infectious diseases, plans to invest up to $384 million to push the candidate through phase 2 clinical trials, the Gaithersburg biotech said Monday. The capital, on top of an initial $4 million from CEPI in March, would help the company increase production for this program — to potentially make up to 100 million vaccine doses by the end of the year for further testing. It would also enable it to increase manufacturing capacity, to produce more than 1 billion doses in 2021, according to Novavax.
A phase 1 trial is slated to start this month in Australia, with results expected in July. Then Novavax said it would initiate the phase 2 portion of the study “in multiple countries.”
If the vaccine ultimately passes all of its clinical testing and wins regulatory approval, Novavax and CEPI expect the vaccine to be distributed globally as part of the Access to COVID-19 Tools (ACT) Accelerator, an initiative overseen by the World Health Organization and other global leaders, the partners said.
The investment is CEPI’s largest to date, said Richard Hatchett, its CEO, in a statement. “Our vaccine R&D programs are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale. We still have a long way to go, but we’re making important steps forward to deliver a safe, effective and globally accessible vaccine as quickly as possible.”
The funding is also a crucial shot in the arm for Novavax, which has been open about the need for hundreds of millions of dollars to get this program across the finish line. It’s working with fellow Gaithersburg biotech Emergent BioSolutions Inc. to get the candidate to the clinic. But reaching patients will take potentially more than a year as testing on larger groups of people is required before getting a vaccine to the masses, despite accelerated timelines and exceptions allowed by the Food and Drug Administration.
Novavax’s stock price skyrocketed 57% Tuesday morning to $38.47 per share, following Monday's announcement after the closing bell.
