Johnson & Johnson Temporarily Pauses Covid-19 Vaccine Trials Due To 'Unexplained' Illness In Study Participant

Pharma major Johnson & Johnson on Monday (12 October) said that it has temporarily paused the the clinical trials of its Covid-19 vaccine candidate due to an "unexplained illness" in a study participant.

The decision regarding resumption of the trials will be taken after careful review of the medical information, the company said.

"We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant," Johnson & Johnson said in a press release.

"Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians," it added.

Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies, the company said.

It should be noted that earlier in September, British-Swedish pharma company AstraZeneca had also halted the clinical trials of its Covid-19 vaccine candidate following a serious adverse event. However, the trials were later resumed after the Medicines Health Regulatory Authority (MHRA) of United Kingdom confirmed that it was safe to do so.