J&J is packing up its HIV vaccine after the shot failed a phase 3 trial, marking the latest setback in a decades-long hunt to prevent one of the most dastardly diseases on the planet.
The world’s largest pharma by revenue said Wednesday that the trial’s data safety monitoring board found that the shot did not perform any better than placebo. As a result, the Mosaico study will end.
Penny Heaton, M.D., Janssen’s global vaccine lead, said in a release that the company was disappointed. “We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine,” she said.
It’s a mighty setback both for the company and also the millions of advocates, activists and global health officials who have worked to tackle HIV once and for all. Unfortunately, all parties are empty-handed, left only with their patience.
The Mosaico trial launched in 2019 and recruited about 3,900 cisgender men and trans people who have sex with other cisgender men and/or trans people. CDC data from 2016 found that gay and bisexual men made up more than half of all HIV patients and the majority of new infections. And 10-year-old data from the Lancet found that trans women were nearly 49 times more likely to have HIV compared to all adults of reproductive age.
The Mosaico failure comes about a year and a half after a similar J&J vaccine regimen failed a phase 2b trial. That study—dubbed Imbokodo—tested the shot in about 2,600 women in sub-Saharan Africa. J&J found that vaccine to be roughly 25% effective, but the lower end of the confidence interval dipped below 0. The regimen used in Mosaico administered four doses of the company’s adenovirus vector vaccine over one year, with soluble protein also administered in the third and fourth visit. This study was run through a private-public partnership that includes the National Institutes of Health and the U.S. Army Medical Research and Development Command.
Beyond the public health implication, the failure marks the latest in a string of poor vaccine showings from J&J. First, the company’s one-shot COVID vaccine has all but evaporated from global use; it is one of three shots authorized in the U.S. The company has also been passed by Moderna in the race for an RSV vaccine.