Novavax starts late-stage trial of COVID-19 vaccine in U.S., Mexico

Novavax announced Monday it is beginning to enroll volunteers for a Phase III clinical trial of its experimental COVID-19 vaccine in the United States and Mexico. The randomized, placebo-controlled study will include up to 30,000 participants at about 115 sites in the two countries. Novavax’s vaccine will become the fifth COVID-19 vaccine to enter late-stage testing in the United States. Public health officials note that despite the launch of the first two COVID-19 vaccines in the United States, additional vaccines will be needed. “We’ve come this far, this fast, but we need to get to the finish line,” said Francis S. Collins, director of NIH, which is helping to fund the Novavax study. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.” The Novavax vaccine includes proteins resembling the “spike” proteins located on the surface of the coronavirus, and they are supposed to generate an immune response to the virus after injection. The vaccine also includes an adjuvant derived from the bark of an evergreen tree native to Chile. In the study, about two-thirds of the participants will receive the vaccine in two doses, 3 weeks apart, while the remainder will receive a placebo. The research is being funded with some of the $1.6 billion that Novavax was awarded this summer by the federal government. The funding, part of Operation Warp Speed, also covers establishing large-scale manufacturing and delivering 100 million doses of the vaccine.