Novavax (finally) prepares for takeoff in the U.S.

As one of America's first big bets under Operation Warp Speed, Novavax's COVID vaccine is notably late to the party as the Maryland biotech seeks a potential FDA emergency use authorization for its COVID shot.

• But company leaders say they see a clear runway to market success for its protein-based product — not only as a booster for the vaccinated but as an alternative first-line defense for those who've refused mRNA shots.

Driving the news: In exactly one week, a key FDA advisory committee will examine Novavax's application for use in adults 18 and older.

"While the mRNA vaccines have done a tremendous job in making vaccine available quickly to the U.S. there still remain vaccine-hesitant, there still remain people who would prefer a different vaccine, a protein-based vaccine, and this is in support of that consumer choice," John Trizzino, Novavax chief business officer, told reporters in a recent briefing.

Zoom in: Novavax's vaccine uses a protein from the target virus combined with what's called an adjuvant which enhances the body's immune response. It can be stored in refrigerators instead of the ultra-cold storage needed by Moderna and Pfizer's vaccines.

• The company ran into production problems after winning $1.6 billion in federal backing in 2020 and struggled to meet FDA standards.
• More recently, a Phase 3 clinical trial in the U.K. found the shot was 83% effective against all COVID-19 infection and 100% effective against severe disease.
• The trial also demonstrated extended protection over a median of 101 days.

The big picture: Novavax's vaccine has already won approval from regulators overseas, along with the World Health Organization and the European Commission for primary vaccination for adults 18 and older.

• Most recently, it received the OK in Japan for use as a primary shot or as a booster.
• It has also been approved for children as young as 12 years old in India, and the company is seeking to expand the use in children to New Zealand, Australia, Great Britain and South Korea. More than 41 million doses of their shots have been delivered, they said.
• Earlier this month, Novavax posted its first profitable quarter ever with a net income of $203 million, up from a net loss of $222.7 million in the same period last year.
• "We see ongoing and annual revaccinations into the foreseeable future," Trizzino said. That includes improving booster rates and addressing the market for kids and adolescents where there has been sluggish uptake, he said.

Yes, but: But demand for COVID vaccines worldwide has cooled. While about 13 million doses of the Novavax vaccine had been distributed in EU countries as of mid-April, fewer than 200,000 were administered, KHN reported.

• "They are applying for an emergency authorization" from the FDA, said Manon Cox, a vaccine industry consultant and the former CEO of Protein Sciences, which made a similar vaccine, told KHN. "What's the emergency?"

But, but, but: Concerns about mRNA technology have kept plenty of Americans on the sidelines when it comes to the vaccines. It's possible, though not probable, they may embrace the Novavax shot, experts have said.

• "The anti-vaxxers have been getting more and more aggressive about mRNA vaccine safety, including in recent months claiming these vaccines cause AIDS," John Moore, a professor of microbiology and immunology at Weill Cornell Medicine told KHN. "It's all utter BS. But some people do buy into this garbage."

What to watch: Beyond their EUA for use in adults, Novavax is planning a Phase 3 trial of its shot for kids 5 to 11 by the third quarter of this year.

• They also have an Omicron variant-specific shot in preclinical trials and expect topline results in the third quarter of 2022.
• Novavax is also working on a Phase 2 combination flu and COVID shot trial by the end of the year and are evaluating a three-dose regimen and different dosing schedules for immunocompromised patients.