J&J pauses COVID-19 vaccine candidate clinical trials

In a statement released late Monday, US healthcare giant Johnson & Johnson (NYSE: JNJ), whose shares dipped 1.5% to $149.50 pre-market today, said it had temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

Following its own guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as its internal clinical and safety physicians. The COVID-19 vaccine candidate, JNJ-78436735, is being developed by J&J’s Janssen Pharmaceutical companies.

Adverse events – illnesses, accidents, etc, - even those that are serious, are an expected part of any clinical study, especially large studies. J&J did not specify the illness, but said: “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”