Facebook Twitter

Johnson & Johnson pauses its COVID-19 vaccine trial because someone got an ‘unexplained illness’

Johnson & Johnson will pause its COVID-19 vaccine trial for now.

SHARE Johnson & Johnson pauses its COVID-19 vaccine trial because someone got an ‘unexplained illness’
This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot, the company announced Monday, Oct. 12, 2020.

This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot, the company announced Monday, Oct. 12, 2020.

Associated Press

Johnson & Johnson said Monday it will temporarily halt its COVID-19 vaccine trial after one of the study participants came down with an “unexplained illness.”

  • Johnson & Johnson said: “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 these illnesses are “an expected part of any clinical study, especially large studies.”

An independent safety committee will review what happened, CBS News reports.

  • Johnson & Johnson said it will pause studies to determine if the illness is related to the vaccine or another event.
  • The company did not explain what the illness was.

Key quote:

  • “Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo,”the company said.

Reason to worry?

Dr. Ashish Jha, the dean of the Brown University School of Public Health, told CNN that halting a trial makes sense and should be expected:

  • “The Johnson & Johnson trial is the biggest trial of the vaccine that I know of — 60,000 people. Within that trial you’d expect a few pauses.”

Another vaccine trial halted

AstraZeneca halted its COVID-19 vaccine trialback in September because one of the volunteers suffered from a neurological complication, which I wrote about for Deseret.com.

  • The trial remains paused in the U.S. while the US Food and Drug Administration reviews the case.