Sanofi’s E. coli Vaccine Fails Phase 3 Trial, Resulting in $250M Impairment Charge

Sanofi and Johnson & Johnson's experimental E. coli vaccine failed to demonstrate sufficient efficacy in a Phase 3 trial1 4.

The E.mbrace study, which aimed to enroll 18,500 people aged 60 years and up, was discontinued following a review by an independent data monitoring committee1 4.

Sanofi will record a $250 million impairment charge as a result of the trial's failure1 6.

The vaccine was intended to prevent invasive extraintestinal pathogenic E. coli disease, a leading bacterial cause of sepsis in older adults1 9.

Sanofi acquired the vaccine candidate from Johnson & Johnson in October 2023 for an upfront payment of $175 million1 2.

No safety concerns were identified during the trial, but the vaccine's efficacy was not sufficient to support continuation1 4.

The study's discontinuation does not affect Sanofi's 2025 financial guidance1 9.

This setback occurs shortly after Sanofi faced a lawsuit from partner Regeneron over alleged withholding of information regarding Dupixent sales6.

The failure impacts a potentially lucrative market, as the vaccine was estimated to potentially generate sales of around $464 million by 2030 if successful4.

Despite the disappointment, Sanofi remains committed to developing innovative vaccines in areas of high unmet need1 6.