Oct. 12 (UPI) — Johnson & Johnson said Monday it has paused all of its COVID-19 vaccine clinical trials after a study participant fell ill.
The pharmaceutical giant said the pause includes the 60,000-volunteer final Phase 3 trial, codenamed ENSEMBLE, of its COVID-19 vaccine candidate being developed by its Janssen Pharmaceutical company.
“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,” the company said in a statement. “Following our guidelines, the participant’s illness is being reviewed and evaluated by ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians.”
The start of Ensemble was announced on Sept. 23 following positive results in an earlier study that showed the vaccine was safe, the company said at the time.
On Monday, Johnson & Johnson said adverse effects including illnesses are expected during clinical studies and that it has “robust mechanisms in place to protect the safety of participants.”
Johnson & Johnson is one of several companies developing potential COVID-19 vaccines and it is not the only one to announce a pause to a late-stage clinical trial.
On Sept. 9, AstraZeneca announced global trials of its vaccine candidates were paused after an unexplained illness in a participant. Earlier this week, the company said it has resumed clinical trials of its candidate vaccine and that it has rapidly advanced into Phase 3 trials.
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