Feb 13 (Reuters) - Johnson & Johnson ( JNJ ) and partner
Sanofi will stop a late-stage trial of an experimental
vaccine to prevent infections caused by the E.coli bacteria due
to a lack of sufficient efficacy, the companies said on
Thursday.
No safety issues related to the experimental vaccine were
identified after an independent review, J&J said and added it
was conducting follow-ups for participants currently enrolled in
the trial.
Sanofi said it has recorded a charge of $250 million related
to the discontinued trial in its fourth-quarter results and
added it will not impact its 2025 forecast provided in January.
Jean-François Toussaint, who heads Sanofi's vaccine research
and development efforts, said the companies will try to
understand the factors behind the lack of sufficient efficacy of
the shot and will share further analysis of the data once
available.
The late-stage study began in June 2021 and enrolled adults
aged 60 years or older who were in stable health but had a
recent history of a urinary tract infection. It was conducted at
over 250 sites across five continents.
The companies were testing the safety and efficacy of a
single dose of the experimental shot, ExPEC9V, in preventing
sepsis and blood infections caused by E.coli.
While most strains of E.coli are harmless, some can cause
serious food poisoning, diarrhea and abdominal cramps.
Last year, 104 people fell sick and 34 were hospitalized due
to an outbreak caused by the O157:H7 strain that was linked to
the McDonald's Quarter Pounder hamburgers.