Novavax Inc. is taking the next step in its journey toward becoming a vaccine powerhouse: advancing a combination vaccine for the coronavirus and seasonal flu.
The Gaithersburg biotech said Wednesday it has started to enroll participants in an early-stage clinical study that will test one shot for both Covid-19 and influenza, about six months after initially indicating its intention to explore the prospect. That phase 1/2 trial will combine NVX-CoV2373, Novavax’s Covid vaccine candidate that’s now on the cusp of regulatory review, and NanoFlu, the company’s flu vaccine candidate that successfully emerged from the clinic in March 2020.
The goal is to assess the combined vaccine’s safety, tolerability and ability to generate an immune response to both viruses.
“The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the health care system and achieve high levels of protection against Covid-19 and influenza with a single regimen,” Dr. Gregory Glenn, Novavax’s president of research and development, said in a statement.
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 seasonal flu and other vaccines, but it swaps in the genetic sequence for the coronavirus in place of the other antigens to fight Covid.
Novavax (NASDAQ: NVAX) plans to enroll 640 healthy adults ages 50 to 70, who have either had Covid previously or who have been vaccinated against the coronavirus at least eight weeks prior. The trial, to be conducted at up to 12 sites in Australia, should have results in the first half of 2022, according to the company.
The study starts a few months after the Covid-NanoFlu combination vaccine performed well in preclinical trials. And it comes as the company continues to hit potholes with manufacturing, and is now waiting until the fourth quarter to seek emergency use authorization from the Food and Drug Administration for its Covid vaccine.
The vaccine developer, which experienced intense growth through the pandemic because of its Covid work, had opened 2020 with positive phase 3 trial results for NanoFlu, before tabling the program to focus on Covid. The flu candidate has taken a backseat to the Covid program and has not been driven across the regulatory finish line. That’s one of the major pivots Novavax made to build up the new product line — though, it expects its coronavirus program to remain a healthy part of its future revenue.
Novavax could face competition in a combined vaccine, with players such as Moderna Inc. (NASDAQ: MRNA) developing its own Covid-flu combination vaccine and others such as Pfizer Inc. (NYSE: PFE) looking to improve their flu vaccines.
But the Montgomery County company has more cooking. It’s now running another trial in the United Kingdom to test a third, or booster, dose of its two-shot Covid vaccine. It’s also testing that vaccine in kids. And it has tapped some new executives to further bolster its team, while simultaneously developing a new manufacturing hub and headquarters campus in Gaithersburg.
After opening Tuesday with a share price of $256.66, Novavax’s stock hit a high Wednesday morning of $277.80 per share, before falling 2% to $265.17 apiece by early afternoon.
