According to disappointing news released today, the world must wait for an approved vaccine that prevents invasive E. coli disease (IED).
Sanofi announced today that a scheduled review of the E.mbrace phase 3 clinical study conducted by an independent data monitoring committee (IDMC) determined that Sanofi and Johnson & Johnson's vaccine candidate for extraintestinal pathogenic E. coli was not sufficiently effective at preventing IED compared to placebo.
As a result of the IDMC's determination, the E.mbrace study is being discontinued.
The study, initiated in June 2021, enrolled older adults with a history of urinary tract infections (UTIs) in the past two years. It was conducted at over 250 sites across five continents. Janssen Research & Development, LLC, is the trial sponsor and responsible party and will continue appropriate safety follow-up for the currently enrolled participants.
Jean-François Toussaint, Sanofi's Global Head of Research and Development Vaccines, commented in a press release on February 13, 2025, "E. coli sepsis is a devastating disease, and no preventative measures are available to date."
In October 2023, Sanofi agreed with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize the vaccine candidate. As a result of the discontinuation, Sanofi has recorded an impairment charge before tax of $250 million in the Q4 2024 results.
UTIs are among the most common bacterial infections, many of which are caused by uropathogenic E. coli. Still, less common pathogens, such as Enterococcus faecalis and other enterococci, can cause infections by infecting an abnormal or catheterized urinary tract.
UTIs are more common in females because their urethras are shorter, making it easier for bacteria to enter the urinary tract. Moreover, younger people also suffer from UTIs.
As of 2025, the U.S. Centers for Disease Control and Prevention says most UTIs can be treated with antibiotics prescribed by a healthcare professional.
However, international travelers seeking access to a non-FDA-approved UTI vaccine (Uromune™, MV140) outside of the USA can submit an appointment request using this Vax-Before-Travel link.