More than 4.7 million people have been infected with COVID-19 in the US and at least 155,000 have died.
Novavax's vaccine contains synthesized pieces of the surface protein that the coronavirus uses to invade human cells, spurring production of antibodies to fight the infection.
The study tested four dose regimens of the vaccine, NVX-CoV2373, against placebo in 131 healthy adults up to 59 years old.
Novavax, of Maryland, said the vaccine was "well-tolerated and had a reassuring safety profile" and provoked an immune response with higher levels of antibodies in people who received the vaccine than in people who had recovered from coronavirus.
The vaccine candidate produced anti-spike IgG antibodies in all subjects after a single 5 µg dose, and numerous subjects also developed wild-type neutralizing antibody responses. "In other words, this is a dose sparing regimen", Novavax R&D chief Gregory Glenn, M.D., said on a conference call on Tuesday. The company also said that out of the total participants, eight volunteers also showed up some side effects of the vaccine including headache, fatigue, and muscle pain. No serious side effects were reported. Moderna followed up its early results with a peer-reviewed study in the New England Journal of Medicine that detailed its "robust" results. That's a concern with the vaccines in development-that it's not known yet if high antibody levels actually translate to protection. The addition of the company's Matrix-M adjuvant, a substance created to boost the body's immune response, did enhance the effect of the vaccine in the study, the company said. Although the Maryland-based biotech was initially left off the list of USA governments finalists for Operation Warp Speed, it later scored a $1.6 billion deal with the initiative-the project's largest funding commitment at the time.
Novavax has never brought a product to market, but it's also advancing a late-stage flu vaccine candidate with plans to file for FDA approval soon. The vaccine candidate developed by the company is one of the very few candidates which are being funded by the Operation Warp Speed which is being led by the White House.