Novavax Inc. (NASDAQ: NVAX) just took another step to bring its Covid-19 vaccine candidate to the global stage, resulting in a stock surge once again.
The Gaithersburg biotech said Thursday it has applied to the World Health Organization for an emergency use listing for its coronavirus vaccine, partnering with the Serum Institute of India on the bid. It’s a crucial step toward getting its product to multiple countries supported by COVAX, a coalition of international vaccine organizations that are working to provide equitable worldwide access to coronavirus vaccines. Novavax already has an agreement in place for Gavi, one of the global vaccine nonprofits behind COVAX, to supply its vaccines to the COVAX facility once it gets market approval. Both WHO and the Serum Institute of India are also working with COVAX.
The submission to WHO “is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” said Novavax President and CEO Stanley Erck in a statement. “It represents another major milestone in Novavax’s transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic.”
It's unclear when WHO will issue a decision, and Novavax has already separately applied for regulatory approval in India, Indonesia and the Philippines. Though, the news of the application itself was enough to jump-start Novavax's shares Thursday. They spiked 11% to close that day at $257.30 apiece. The stock has since dipped, trading down 2.8% at about $250 per share by Friday afternoon.
Novavax has yet to submit a similar application for federal approval to the U.S. Food and Drug Administration as it continues to work through manufacturing delays that had previously pushed back that step to later this year. The company confirmed Friday to the Washington Business Journal that it still intends to submit its application to the FDA in the fourth quarter.
Novavax, which is developing a new manufacturing hub in Gaithersburg, also plans to file for authorization of its Covid vaccine in Australia, New Zealand, Canada and the United Kingdom — where it’s entering the product into another clinical trial to study its effectiveness, particularly in adolescents, when given with a vaccine from another manufacturer. The company is simultaneously running a separate trial, also in the U.K., to test a booster dose of its two-shot Covid vaccine, while also studying that vaccine in kids. And it’s enrolling participants in an early-stage clinical study that will test a single combination shot for both Covid-19 and the seasonal flu.
Since the Covid pandemic began, the company has underwent an unprecedented business transformation that included $1.6 billion in funding from the federal government, another $400 million from the Coalition for Epidemic Preparedness Innovations and more substantial funding from a slew of stock sales to complete its Covid vaccine clinical trials, which showed considerable effectiveness against the original and variant strains.
Through those funding deals and other agreements it's inked in recent months, Novavax has committed to supplying 110 million doses to the U.S. government, roughly 1.1 billion doses to the Gavi/COVAX facility and up to 400,000 doses to the European Commission and the governments of the U.K., Canada, Australia, New Zealand and Switzerland should the product win final authorization.
Its protein-based Covid vaccine uses what’s called recombinant nanoparticle technology, making it different from messenger RNA and viral vector vaccines. It’s the same platform Novavax uses for its experimental seasonal flu and other vaccines, but it swaps in the genetic sequence for the coronavirus in place of the other antigens to fight Covid.
Related: Read our cover story on Novavax's substantial evolution through the Covid crisis.
