Novavax’s experimental coronavirus vaccine becomes one of at least 10 now being tested in people.
Photo: andrew caballero-reynolds/Agence France-Presse/Getty ImagesNovavax Inc. said Monday it started the first human study of its experimental coronavirus vaccine, making it one of at least 10 shots now being tested in people globally for Covid-19.
The Gaithersburg, Md., company said it plans to enroll about 130 healthy people ages 18 to 59 at two sites in Australia for the study. It expects initial results in July showing whether the vaccine, code-named NVX-CoV2373, is safe and triggers immune responses in participants.
If initial results are promising, Novavax plans a second phase of the study to be conducted in multiple countries including the U.S. and in a broader age range. The second portion of the study also will test whether the vaccine reduces the risk of Covid-19, Novavax said.
Novavax Chief Executive Stanley Erck said the company has started to scale up manufacturing before knowing whether the vaccine will be proven in studies to work safely. Normally, he said, the company would have waited six to nine months to start the buildup.
“We went at risk and started manufacturing at a larger scale,” he said in an interview. “Time is the most important thing here.”
Because of the manufacturing buildup, Novavax said it could produce up to 100 million doses this year, and potentially more than one billion in 2021.
More than 120 experimental coronavirus vaccines are in development world-wide, according to the World Health Organization, including efforts by Moderna Inc. and Pfizer Inc. that are in human testing.
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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.
Some but not all subjects of the phase 1 trial will receive a vaccine that also has an ingredient called an adjuvant, designed to enhance the immune response. Novavax’s adjuvant is derived from the bark of an evergreen tree native to Chile.
Study subjects will receive two doses of the vaccine, three weeks apart.
Novavax, founded in 1987, has no products on the market. It is developing vaccines against influenza and other viruses.
The company’s efforts have gotten a boost from the Coalition for Epidemic Preparedness Innovations, an Oslo-based nonprofit that has pledged as much as $388 million in funding for Novavax’s coronavirus vaccine.
The CEPI funding is helping the company run clinical trials and begin ramping up production of doses. In return, Novavax has pledged to expand manufacturing outside the U.S. and to participate in a global allocation system for doses. Novavax currently manufactures portions of its developmental vaccines in the U.S. and Sweden.
Write to Peter Loftus at peter.loftus@wsj.com
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