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"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.
According to a Reuters report, the company said that such pauses are normal in big trials. It said the “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” required by health authorities. The current case is a pause. The company has not given details on the illness.
The company began its large-scale, multi-country Phase 3 trial for its vaccine candidate, JNJ-78436735 last month after Phase 1 and Phase 2 trials showed positive results.
Last month, the British-Swedish biopharmaceutical giant AstraZeneca had also put a hold on its ongoing late-stage trials of Covid 19 vaccine after a participant developed a serious reaction to it. A news report by PTI said that trials have been paused until the company determines if the ‘potentially unexplained’ illness is a side effect of the vaccine. It was resumed following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.