A small company that’s been developing new vaccines since Reagan was President, Novavax (NASDAQ:NVAX) announced its first late-stage clinical trial victory on Thursday afternoon. The company’s COVID-19 vaccine candidate, NVX-CoV2373, reduced volunteers’ chances of getting COVID-19 by 89.3% compared to a placebo.
Novavax’s first phase 3 clinical trial win comes from a 15,000-patient study in the U.K. A majority of the positive cases reported were of the now-predominant U.K. variant. NVX-CoV2373 appears just as effective at preventing the U.K. variant as the original coronavirus strain.
Investigators ran an interim analysis after 62 participants tested positive for COVID-19. All but six of them were in the placebo group. With a 95% confidence interval adjustment, that works out to an 89.3% efficacy rate overall.
Of the aforementioned 62 cases, 32 had the U.K. strain, 24 had the original strain, and six were unknown.Extrapolating from this limited sample, it looks like NVX-CoV2373 is 85.6% effective against the U.K. variant and 95.6% effective against the original recipe.
Unfortunately for those of us in the U.S., the Food and Drug Administration isn’t willing to review an emergency use authorization application without results from a mostly domestic phase 3 study. The company has randomized over 16,000 patients in a North American trial designed to meet the FDA’s requirements. It has a total enrollment goal of 30,000 patients.