Gert van der Hoek
In Memoriam - Editor, Senior Moderator
Johnson & Johnson said it has paused further dosing in all clinical trials of its experimental Covid-19 vaccine because a study volunteer had an unexplained illness.
The pause announced Monday affects all trials of J&J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll as many as 60,000 people in the U.S. and several other countries.
An independent data-safety monitoring board is reviewing the study subject’s illness, the company said. The company didn’t immediately disclose more information about the illness, and said it needed to respect the subject’s privacy.
This is the second time trials for a Covid-19 vaccine trial have been paused over a safety concern. Last month, AstraZeneca PLC paused clinical trials of an experimental Covid-19 vaccine after a participant in a U.K. study had an unexplained illness. The U.K. study resumed, but a large U.S. study is still on hold.
J&J, of New Brunswick, N.J., said illnesses and other side effects are an expected part of any clinical study, and it has prespecified guidelines to monitor for the events.
The pause announced Monday affects all trials of J&J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll as many as 60,000 people in the U.S. and several other countries.
An independent data-safety monitoring board is reviewing the study subject’s illness, the company said. The company didn’t immediately disclose more information about the illness, and said it needed to respect the subject’s privacy.
This is the second time trials for a Covid-19 vaccine trial have been paused over a safety concern. Last month, AstraZeneca PLC paused clinical trials of an experimental Covid-19 vaccine after a participant in a U.K. study had an unexplained illness. The U.K. study resumed, but a large U.S. study is still on hold.
J&J, of New Brunswick, N.J., said illnesses and other side effects are an expected part of any clinical study, and it has prespecified guidelines to monitor for the events.
