Novavax taps Sanofi, Supernus vets amid quest to get its COVID-19 vaccine over the FDA finish line

Novavax vaccine
Novavax now expects to file its COVID-19 shot for a U.S. emergency nod in the fourth quarter. (Novavax)

Novavax has enlisted a pair of industry heavyweights on the quest to push its recombinant COVID-19 vaccine hopeful across the finish line.

The biotech’s new senior vice president of quality assurance, Nasir Egal, Ph.D., hails from Sanofi, while Jim Kelly, Novavax’s new chief financial officer and treasurer, joins from Supernus Pharmaceuticals. Novavax will channel the execs’ quality and commercial know-how toward its experimental COVID-19 vaccine NVX-CoV2373, which it plans to file for an emergency use authorization (EUA) in the U.S. in the fourth quarter.

The news comes after Novavax reported series of vaccine manufacturing and supply issues this year, which forced it to delay its FDA filing timeline from May to July, and then into the final three months of the year.

Egal spent nearly 10 years at Sanofi, working up to the role of head of global quality external affairs. Before Sanofi, he worked in global and regional quality and compliance at pharma heavyweights Novartis and Merck & Co. He’s also served at the U.S. Food and Drug Administration as a research scientist, Novavax said.

RELATED: Novavax's COVID-19 shot won't see much U.S. use, but a big global market awaits: analyst

For his part, Kelly served as CFO Supernus and had a ten-year run as Vanda Pharmaceuticals’ CFO and treasurer before that. His resume also includes financial roles at Biogen and MedImmune. 

Novavax will count on Kelly’s financial and strategic expertise as it “quickly matures into a global commercial company,” Novavax CEO Stanley Erck said in a statement. The biotech, which formed in 1987, has never brought a vaccine to market.

Throughout 2020, Novavax’s shot ranked among the big five expected to comprise the United States' vaccine response in 2021 alongside shots from Pfizer, Moderna, Johnson & Johnson and AstraZeneca. Pfizer and Moderna were the first to win U.S. emergency nods with their mRNA vaccines, followed by Johnson & Johnson with its single-dose prophylactic. AstraZeneca’s shot has not been authorized stateside.

But Novavax’s shot hasn’t had the easiest path to a filing. While the vaccine recently posted 90.4% efficacy in a pivotal phase 3, putting it in a similar league to Pfizer and Moderna’s vaccines, Novavax has stumbled on manufacturing.

The biotech had originally hoped to apply for an EUA in the second quarter, but in May, Novavax said it would push back filings in the U.K., U.S. and European Union into the third quarter. At the time, the company flagged production issues related to an assay needed to prove cross-site manufacturing consistency data to regulators. The company has also had trouble sourcing raw materials like bioreactor bags, depth filters and growth media, though a company spokesperson told Fierce Pharma in late July that those problems have “generally been resolved.”

RELATED: Moderna and Novavax grapple with COVID-19 vaccine supply hiccups overseas: reports

In an August regulatory filing, Novavax disclosed another delay, stating that the U.S. wanted it to work with the FDA on issues related to analytic methods before advancing additional U.S. manufacturing. “We’re talking weeks here, we’re not talking months,” Novavax CEO Stanley Erck said on an analyst call at the time.

Meanwhile, Novavax recently finalized a deal to sell the European Commission 200 million doses of its vaccine. Under the deal, Novavax is on deck to supply 100 million doses, plus an option for 100 million more, through 2023. It says it aims to complete its rolling submission to the European Medicines Agency in the third quarter.

Elsewhere, Novavax has pledged 100 million doses to the U.S. and 1.1 billion doses to low- and middle-income countries.