COVID-19: Johnson & Johnson pauses vaccine candidate clinical trials
Johnson & Johnson said it had temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic, according to news reports.
The pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world.
The participant’s illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians, the company said https://www.jnj.com/our-company/johnson-johnson-temporarily-pauses-all-dosing-in-our-janssen-covid-19-vaccine-candidate-clinical-trials in a statement.
“At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world,” the statement added.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles,” it said.