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