J&J pauses COVID-19 vaccine trials due to unexplained illness in participant


  • Dawn O'Shea
  • Univadis Medical News
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Johnson & Johnson has temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant.

In a statement, the company said it has temporarily paused further dosing in all its COVID-19 vaccine candidate trials, including the Phase 3 ENSEMBLE trial as a result of the event. The participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as internal clinical and safety physicians.

This latest trial pause is another major blow for the race to find a safe and effective vaccine. Last month AstraZeneca paused its trial of another vaccine candidate. The vaccine, being developed in collaboration with Oxford University, was put on hold after a participant developed "a potentially unexplained illness". No further details of the condition were given. However, there are reports it is the neurological disorder transverse myelitis.

The AstraZeneca/Oxford trial has since resumed in Japan, UK, Brazil, South Africa and India resumed, but US trials remain paused as regulators widened their probe.

No further details have been release about either case.