Sanofi and Johnson & Johnson’s E. coli Vaccine Candidate Fails in Phase 3 Trial

Sanofi and Johnson & Johnson's experimental E. coli vaccine failed to show significant benefit over placebo in a Phase 3 study13.

The vaccine was designed to prevent invasive E. coli disease (IED), including sepsis and blood infections, in adults aged 60 and over13.

An independent data monitoring committee determined the vaccine was not sufficiently effective at preventing IED compared to placebo78.

The E.mbrace study, which enrolled nearly 20,000 participants across five continents, is being discontinued57.

No safety concerns were identified during the trial137.

Sanofi will record a $250 million impairment charge as a result of the study's failure168.

The vaccine candidate, known as ExPEC9V, was once projected to potentially generate between 2 billion and 5 billion euros in peak sales1.

This outcome marks a setback in efforts to develop the first vaccine against a strain of E. coli responsible for most urinary tract infections and other serious conditions1.

Both companies expressed disappointment but remain committed to further analysis of the data and sharing results with the scientific community578.

The failure highlights the challenges in developing vaccines for antibiotic-resistant bacterial infections1.

Sources:

1. https://www.biopharmadive.com/news/sanofi-e-coli-vaccine-discontinued-charge-johnson-johnson/740037/

3. https://www.contagionlive.com/view/investigational-e-coli-vaccine-does-not-demonstrate-sufficient-efficacy-in-phase-3-study

5. https://www.clinicaltrialsarena.com/news/jj-stops-phase-iii-trial-of-sanofi-e-coli-vaccine-citing-disappointing-results/

6. https://www.biospace.com/drug-development/sanofi-hit-with-250m-impairment-after-scrapping-j-j-partnered-e-coli-vaccine

7. https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-phase-3-e-mbrace-study

8. https://www.sanofi.com/en/media-room/press-releases/2025/2025-02-13-06-00-00-3025576