J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness
Shots:
- J&J temporarily pauses the further dosing in all clinical studies of its COVID-19 vaccine candidate JNJ-78436735- including the P-III ENSEMBLE trial- due to an "unexplained illness" in one participant
- Following the guidelines- the subject's illness is being reviewed and evaluated by the ENSEMBLE independent DSMB- as well as its own internal clinical and safety physicians. J&J reported that all clinical studies it conducts have prespecified guidelines allowing them to pause if an unexpected SAEs occurred
- The pause of the ENSEMBLE study comes just over a month after AstraZeneca confirmed that its P-III study was put on hold due to a possible safety issue. J&J had started the ENSEMBLE study last month to evaluate the safety and efficacy of a single vaccine dose in preventing COVID-19
Ref: J&J | Image: RSSing.com
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