Novavax said the results support further testing, including a 30,000-person final-stage study slated to start in the fall.
Photo: Patrick Rocca/Nucleus Network/ABC/Associated PressNovavax Inc. NVAX 0.83% said Tuesday its experimental coronavirus vaccine induced promising immune responses and was generally well-tolerated in healthy adults in the first human study of the shot.
Two weeks after taking a second dose, most vaccinated subjects had high levels of so-called neutralizing antibodies, which are immune-system agents believed to be most effective at fighting the virus, according to results in a paper that Novavax NVAX 0.83% submitted to the preprint server medRxiv, with hopes of publishing it in a peer-reviewed journal.
The antibody concentrations were similar to those seen in serum samples from hospitalized Covid-19 patients, and exceeded levels seen in non-hospitalized patients, according to the paper, which hasn’t yet been reviewed by independent experts.
“It’s highly immunogenic,” or able to produce immune responses, Gregory Glenn, Novavax’s president of research and development, said in an interview.
The vaccine also induced a favorable type of response from other components of the immune system, known as T-cells, which researchers think may help avoid a rare complication when a vaccine worsens the severity of disease.
Novavax, of Gaithersburg, Md., said the results support further testing, including a large, 30,000-person final-stage study slated to start in the fall. That study will test whether the immune responses triggered by the vaccine safely protect people from Covid-19.
The company is one of several that have received hefty funding from the U.S. government to support manufacturing and testing of coronavirus vaccine doses. Novavax will receive up to $1.6 billion, and in turn has pledged to deliver 100 million doses for use in the U.S., starting by the end of the year assuming clinical trials are successful.
The company also plans to manufacture doses for other countries.
Novavax, founded in 1987, has no products on the market and was in troubled financial shape last year. But its effort to make a coronavirus vaccine, and another one that looks promising against influenza, have propelled a 3,800% gain in its stock price year-to-date.
More than 160 experimental coronavirus vaccines are in development globally, including more than 25 that have started human testing, according to the World Health Organization.
Vaccines in the most advanced stages of testing include shots developed by Moderna Inc., Pfizer Inc. with partner BioNTech SE, and the University of Oxford with partner AstraZeneca PLC. Initial human study results for these vaccines have been released in recent weeks, and have shown they have induced immune responses and were generally safe.
Novavax’s vaccine contains proteins resembling those found on the surface of the new coronavirus, which are supposed to trigger an immune response to the virus once injected. Novavax manufactures the proteins in insect cells.
Novavax started the first human study of its vaccine in May in Australia, enrolling about 130 people ages 18 years to 59 years. Subjects received two shots, three weeks apart.
Of the different regimens tested, the most optimal appeared to be a lower dose of the vaccine with an adjuvant, which is a component designed to enhance immune responses. It “is very attractive from a manufacturing standpoint. You can make a huge number of doses,” Dr. Glenn said.
Study subjects experienced side effects including tenderness and pain at the injection site, headaches and fatigue. Novavax said most side effects were generally mild and didn’t last long, but there were some more severe cases of fatigue and muscle pain.
Novavax received funding for the first human study of its vaccine from the Coalition for Epidemic Preparedness Innovations, a Norway-based nonprofit that funds early development for vaccines against emerging infectious diseases. With CEPI backing, Novavax has agreed to set up manufacturing outside the U.S., to supply other countries with vaccine doses, in addition to its U.S. manufacturing.
Write to Peter Loftus at peter.loftus@wsj.com
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