Novavax seeks UK authorization for COVID vax

Novavax Inc. has filed for regulatory approval of its Covid-19 vaccine candidate in the U.K. — a major step toward seeking approval in more countries, including the U.S.

The Gaithersburg biotech said Wednesday it has completed all of the requirements for its submission to the U.K.’s regulatory agency, after kicking off a rolling review process earlier this year. It’s a big step for the company, which has faced numerous manufacturing challenges that have prolonged its ability to get its protein-based vaccine across the finish line in multiple markets.

The submission brings the business “significantly closer to delivering millions of doses” of its product, Novavax President and CEO Stanley Erck said in a statement. The company “will be prepared to deliver vaccine doses following what we anticipate will be a positive decision,” he said.

That’s doable because these doses are made through a partnership with the Serum Institute of India. And to that end, “in the near future, we expect to supplement this filing with supply from our global supply chain,” Novavax Chief Operations Officer Rick Crowley said in a statement.

It comes after Novavax successfully completed late-stage clinical trials of the vaccine candidate, including a phase 3 study of 15,000 participants in the U.K. that demonstrated 96.4% efficacy against the original strain of the coronavirus and 89.7% efficacy overall, including variants. The other big trial of 30,000 people in the U.S. and Mexico showed 100% protection against moderate and severe disease and 90.4% efficacy overall.

Those results paved the way for the company to seek federal authorization for its vaccine. But even after initiating a rolling review process with the Food and Drug Administration in February, the company has continued to battle with supply-chain issues and other manufacturing problems that pushed back its target date to seek a green light to market.

Novavax said Wednesday it expects to get its full submission to the FDA by year’s end. That’s after issuing a statement Oct. 20 stating it’s on track and confident “that our vaccine will soon play a significant role in the global Covid-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world’s ability to end the pandemic: global distribution challenges and vaccine hesitancy,” Erck said at the time.

That came in response to a Politico report that the manufacturing challenges will continue much longer.

Novavax expects to advance its application in other markets — including other parts of Europe, Canada, Australia and New Zealand — “shortly following the U.K. submission,” the company said. Novavax applied to the World Health Organization for an emergency-use listing for its coronavirus vaccine, in partnership with the Serum Institute of India, in late September. It has also sought an OK in India, Indonesia and the Philippines.

In the U.K., Novavax is running a different clinical trial to study its vaccine’s effectiveness, particularly in adolescents, when given with a vaccine from another manufacturer. There, the company is also running a study to test a booster dose of its two-shot Covid vaccine, while separately studying that vaccine in kids. And it’s kicking off an early-stage clinical study that will test a single combination shot for both Covid-19 and the seasonal flu.

Meanwhile, the company continues bolstering its leadership team, most recently with some changes in early October. The company appointed Dr. Denny Kim, most recently of Johnson & Johnson, to senior vice president, chief safety officer and head of global vaccine safety — a new position for the business. Novavax also promoted Dr. Raburn Mallory, an AstraZeneca PLC alum, to senior vice president and head of clinical development; and Marco Cacciuttolo, a vice president with the company since July 2020, to senior vice president of process and analytical development.

Since the Covid pandemic began, the business has experienced a storybook 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 get its Covid vaccine through clinical trials.

Through those funding deals and other agreements, Novavax has committed to supplying 110 million doses to the U.S. government; roughly 1.1 billion doses to COVAX, a coalition of international vaccine organizations that are working to provide equitable worldwide access to coronavirus vaccines; and up to 400,000 doses to the European Commission and the governments of the other countries where it hopes the product will earn final authorization.

Novavax, which is developing a new manufacturing hub in Gaithersburg, uses what’s called recombinant nanoparticle technology in its vaccine, 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. The Business Journals