Johnson & Johnson (J&J) has halted further dosing in all Janssen’s Covid-19 vaccine candidate clinical trials, as a result of unexplained illness in a study participant.
The halted trails also include the large-scale, pivotal and multi-country phase 3 ENSEMBLE trial of the company’s Covid-19 vaccine candidate called JNJ-78436735, which is being developed by Janssen Pharmaceutical Companies.
J&J’s phase 3 ENSEMBLE trial, which started in September, planned to recruit up to 60,000 volunteers across three continents to assess the safety and efficacy of a single vaccine dose against placebo in preventing Covid-19.
The company intended to recruit participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the US.
The trial will have people with and without comorbidities relating to an increased risk for progression to severe Covid-19, said J&J.
J&J stated that it is committed to providing transparent updates across the clinical development process its vaccine candidate in line with regulatory standards and ethical and scientific principles.
The ENSEMBLE independent Data Safety Monitoring Board (DSMB), as well as, J&J’s internal clinical and safety physicians will analyse and assess the illness of the patient following the company’s guidelines.
All clinical studies carried out by the Janssen Pharmaceutical Companies of Johnson & Johnson have pre-specified guidelines, said the company.
In September, J&J company Janssen Pharmaceuticals partnered with injectable contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (GRAM) to produce its SARS-CoV-2 vaccine candidate.
The scope of the deal comprises technical transfer and fill and finish manufacture of J&J’s SARS-CoV-2 vaccine candidate.