Logo

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

Share this

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions