A late-stage trial of an experimental vaccine to prevent infections caused by the E. coli bacteria will be discontinued by Johnson & Johnson and partner Sanofi on Thursday because it is not effective enough, the companies announced.
According to J&J, an independent review revealed no safety concerns with the experimental vaccine, and the company also stated that it was following up with trial participants.
In its fourth-quarter results, Sanofi reported a $250 million charge associated with the discontinued trial; however, it clarified that this charge would not affect its January 2025 forecast.
Sanofi’s head of vaccine research and development, Jean-François Toussaint, stated that the companies will share additional data analysis as soon as it is available and will attempt to identify the reasons why the shot is not effective enough.
Participants in the late-stage study, which started in June 2021, had to be 60 years of age or older, in stable health, and have recently experienced a urinary tract infection. It was carried out at more than 250 locations on five continents.
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In order to determine whether a single dose of the experimental shot, ExPEC9V, could prevent sepsis and blood infections brought on by E. coli, the companies conducted tests.
Although the majority of E. coli strains are not harmful, some can result in severe food poisoning, cramping in the abdomen, and diarrhea.
The O157:H7 strain that was connected to McDonald’s Quarter Pounder hamburgers caused an outbreak last year that resulted in 104 illnesses and 34 hospitalizations.
