A small company that has developed new vaccines since Reagan was president, Novavax (NASDAQ: NVAX) announced its first final-stage clinical trial victory on Thursday afternoon. The company’s COVID-19 candidate vaccine, NVX-CoV2373, reduced the volunteers’ chances of getting COVID-19 by 89.3% compared to a placebo.
Image source: Getty Images.
The victory of Novavax’s first phase 3 clinical trial comes from a study of 15,000 patients in the UK. Most of the positive cases reported were of the variant now prevalent in the UK. NVX-CoV2373 appears to be as effective in preventing the UK variant as the original coronavirus strain.
The investigators performed 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, this results in an overall effectiveness rate of 89.3%.
Of the 62 cases mentioned above, 32 had the United Kingdom strain, 24 had the original strain and six were unknown. Extrapolating from this limited sample, it appears that NVX-CoV2373 is 85.6% effective against the UK variant and 95.6% effective against the original recipe.
Unfortunately for us in the US, the Food and Drug Administration is not willing to review an emergency use authorization application without the results of a phase 3 study that is primarily domestic. The company randomized more than 16,000 patients in a North American study designed to meet FDA requirements. It has a total enrollment goal of 30,000 patients.