Novavax Inc. is building a new unit and team to get its seasonal flu vaccine program across the finish line and to the public after pumping the brakes earlier this year to turn its focus to its Covid-19 vaccine candidate.
The Gaithersburg biotech has promoted Russell “Rip” Wilson, its senior vice president of business development since 2011, to executive vice president and NanoFlu general manager — a new position created to focus on advancing its NanoFlu seasonal flu vaccine candidate. He’ll also lead the charge in exploring a potential combined flu and Covid-19 vaccine “that could be used in a postpandemic setting,” the company said Tuesday.
He’ll lead a team of existing Novavax (NASDAQ: NVAX) executives, including:
- Tim Hahn, senior vice president of chemistry, manufacturing and controls for NanoFlu. He’s held this role since the beginning of NanoFlu's inception and spearheaded the creation of a global supply chain for Novavax’s Matrix-M adjuvant, an important element of both the company’s Covid-19 and flu vaccines. He’s an alum of MedImmune and Merck.
- Dr. Vivek Shinde, vice president of clinical development for NanoFlu, who’s also led clinical work for the program since its start. His resume includes posts at GlaxoSmithKline PLC (NYSE: GSK), the World Health Organization, and the Centers for Disease Control and Prevention, before joining Novavax in 2015.
This team will function as a separate development unit within the company. They hope to file an application to the Food and Drug Administration for NanoFlu's approval, while Novavax continues to develop and manufacture its coronavirus vaccine candidate, NVX-CoV2373, said President and CEO Stanley Erck in a statement. NanoFlu had elicited successful results from its phase 3 clinical trial in March on older adults aged 65 and up, and it had been placed on the FDA's regulatory fast track at the start of this year.
“Currently, available flu vaccines provide inconsistent, inadequate protection against seasonal influenza,” Wilson said in a statement, adding that he is “committed to leading our team to licensure with a strong sense of urgency.”
Novavax’s stock was trading up nearly 8% to about $119 per share Tuesday afternoon. Its share price has surged dramatically since the start of 2020, climbing from $4 apiece to a nearly $190 five-year high in August — largely driven by its work in advancing a coronavirus vaccine candidate.
But NanoFlu, too, holds great promise for the company, after an otherwise turbulent 2019 that included a failed late-stage clinical trial for a respiratory syncytial virus vaccine and a delisting threat from the Nasdaq. Novavax had put the flu vaccine program on hold this summer to focus on Covid, at the time deviating from a plan to push NanoFlu through the approval process in time for the 2021 flu season and then perform another required phase 3 test after its licensure. Now, per Novavax’s announcement Tuesday, it seems to be returning to that original plan.
The company has also said it needs more space for its NanoFlu program — and it’s already in expansion mode, recently inking a lease for lab space at 704 Quince Orchard Road in Gaithersburg.
We’ve reached out and will update this post as we hear back.
Novavax is one of a handful of companies nationwide in late-stage trials for a Covid-19 vaccine candidate, all seeing mixed results thus far. Johnson & Johnson (NYSE: JNJ) this week temporarily halted studies of its own experimental coronavirus vaccine to investigate a participant’s illness. That comes a month after AstraZeneca PLC (NASDAQ: AZN) paused its phase 3 trial of a Covid-19 vaccine candidate for the same reason. While pausing such clinical trials isn't abnormal at this late stage, it offers a reminder of a vaccine company's long road before reaching FDA approval for commercial use.
