J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

 J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

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

    Click here ­to­ read full press release/ article | Ref: J&J | Image: RSSing.com

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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