• Revenue Cycle Management
  • COVID-19
  • Reimbursement
  • Diabetes Awareness Month
  • Risk Management
  • Patient Retention
  • Staffing
  • Medical Economics® 100th Anniversary
  • Coding and documentation
  • Business of Endocrinology
  • Telehealth
  • Physicians Financial News
  • Cybersecurity
  • Cardiovascular Clinical Consult
  • Locum Tenens, brought to you by LocumLife®
  • Weight Management
  • Business of Women's Health
  • Practice Efficiency
  • Finance and Wealth
  • EHRs
  • Remote Patient Monitoring
  • Sponsored Webinars
  • Medical Technology
  • Billing and collections
  • Acute Pain Management
  • Exclusive Content
  • Value-based Care
  • Business of Pediatrics
  • Concierge Medicine 2.0 by Castle Connolly Private Health Partners
  • Practice Growth
  • Concierge Medicine
  • Business of Cardiology
  • Implementing the Topcon Ocular Telehealth Platform
  • Malpractice
  • Influenza
  • Sexual Health
  • Chronic Conditions
  • Technology
  • Legal and Policy
  • Money
  • Opinion
  • Vaccines
  • Practice Management
  • Patient Relations
  • Careers

Johnson & Johnson pauses COVID-19 vaccine trial after patient's 'unexplained illness'


The company says it is investigating before determining next steps in the COVID-19 vaccine trial.

covid-19 vaccine

Johnson & Johnson announced Monday that the company is pausing its phase 3 COVID-19 vaccine trial after a clinical trial participant contracted an "unexplained illness," the company said in a statement.

The pause in the closely watched trial, dubbed ENSEMBLE, was first reported by STAT News.

"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 statement read.

The company said that such outcomes are common in clinical trials, and stressed the difference between a study pause — which could be a short and only temporary occurence — and a regulatory hold, which is a formal action by the FDA that can mean much longer delays.

The company said it is undertaking a "careful review of all of the medical information before deciding whether to restart the study."

The ENSEMBLE trial began in late September, and is one of nearly a dozen phase 3 trials as pharmaceutical companies race to develop a COVID-19 vaccine, according to a tracking database published by the New York Times. ENSEMBLE involves more than 60,000 volunteer patients across three continents.

It is not the only COVID-19 vaccine trial that has had to halt investigations. In early sepetmber, the vaccine candidate from AstraZeneca and Oxford University paused for a "side effect" experienced by a patient. That trial resumed about a week later in the United Kingdom, but remains on hold in the United States.

Related Videos
© National Institute for Occupational Safety and Health