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October 13, 2020

Health Law Daily

J&J Pauses COVID-19 Vaccine Trial After Participant Develops Mystery Illness

  • October 13, 2020

Bloomberg (10/12, Griffin) reports Johnson & Johnson has confirmed that it has “temporarily halted” its COVID-19 vaccine trial “due to an unexplained illness in a trial participant, the second time that a front-runner developer has encountered this situation in the intensifying race for immunization.” J&J “said in a statement late Monday the participant’s illness is being evaluated, and that it would share more information after investigation.” The pause, while fairly routine for such trials, “raises concern over safety issues as [COVID-19] vaccine candidates have progressed at unprecedented speed this year.”
      CNN (10/12, Fox) also covers the pause of J&J’s “ENSEMBLE” study, adding that Johnson & Johnson’s “Janssen vaccine arm is developing the shot. The company did not say what the unexplained illness was, but one point of clinical trials is to find out if vaccines cause dangerous side effects.” In a statement, J&J stressed that “there is a ‘significant distinction’ between a study pause and a regulatory hold on a clinical trial.” CNN reports, “AstraZeneca’s vaccine trial was paused last month because of a neurological complication in a volunteer in Britain.”
      Also reporting are USA Today (10/12, Weise, Weintraub), Reuters (10/12, Bera, Beasley, Henderson, Burger), the Wall Street Journal (10/12, Loftus, Subscription Publication), the Associated Press (10/12), NBC News (10/13, Madani), the Daily Caller (10/12, Lyman), The Hill (10/12, Bowden), and Politico (10/12, Lim).