Novavax begins phase 3 vaccine trial in U.S.

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Novavax announced on Monday that it will enroll up to 30,000 volunteers in the United States and Mexico to participate in its phase 3 COVID-19 vaccine trial. The Gaithersburg-based company will become the fifth to begin phase 3 trials in the U.S.

Novavax already has a phase 3 trial underway in the United Kingdom, with phase 1 and 2 trials ongoing in the U.S., Australia and South Africa. NVX-CoV2373, Novavax’s vaccine candidate, is a protein-based vaccine and does not need to be kept at below-freezing temperatures, making it easier to store and distribute.

Like other COVID-19 vaccine candidates, NVX-CoV2373 requires two shots. The first and second shot are to be taken three weeks apart.

Despite having two vaccines now approved by the Food and Drug Administration, companies nationwide continue to develop their products in hopes of vaccinating as many people as possible as quickly as possible.

“We’ve come this far, this fast, but we need to get to the finish line,” said Francis S. Collins, director of the National Institutes of Health, in a statement. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.”

Novavax hopes to recruit a large number of people from demographics that are at high risk for COVID-19, stating in a press release that the company is aiming for at least 25% of participants to be over 65, at least 15% to be Black, between 10-20% to be Latino, and between 1-2% to be Native America. The trial organizers also plan to recruit people with underlying health conditions.

The trial will be conducted in collaboration with Operation Warp Speed, which provided $1.6 billion of funding to Novavax in July.

“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry and the community,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, said in a statement. “The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”