teaHe has paused research on Johnson & Johnson’s Covid-19 vaccine. Due to the unexplained disease of study participants.
Documents sent to external researchers running clinical trials with 60,000 patients showed that the “pause rule” was met, the online system used to enroll patients in the study was shut down, and the Data and Safety Monitoring Committee was in the trial A committee will be convened to monitor patient safety. Documentation was obtained by STAT.
Upon contact from STAT, J&J confirmed a study pause due to “the study participant’s unexplained disease”. The company did not provide details.
“We must respect the privacy of this participant. We are also learning more about this participant’s illness and it’s important to get all the facts before sharing any additional information,” the company said in a statement.
J&J emphasized that so-called adverse events (diseases, accidents, and other bad medical outcomes) are an expected part of a clinical study, and the difference between study suspension and clinical hold. Lasts much longer. Vaccine research is currently not pending clinical trials. J&J said they usually communicate clinical hold to the public, but generally do not inform the public of study suspension.
The Data and Safety Monitoring Committee (DSMB) convened late Monday to review the case. J&J said that “it’s not always immediately obvious” whether participants who experienced side effects in cases like this were given study treatment or placebo.
While clinical trial pauses are not uncommon (and in some cases last only a few days), they are generating enormous interest in the competition to test a vaccine against SARS-CoV-2, the virus that causes Covid-19.
Given the scale of Johnson & Johnson’s clinical trials, it’s not surprising that the study could be paused, and other things could happen if this was resolved, said a source familiar with the study.
“If we study 60,000 people, it’s a small town,” the source said. “There are many medical events in a small town.”
On September 8, a large study of another Covid-19 vaccine under development at AstraZeneca and Oxford University was put on hold due to suspected side effects in patients in the UK. It is believed that the patient has transverse myelitis, a spinal cord problem. Research on the vaccine resumed about a week after it was discontinued in the UK and has since resumed in other countries. However, it is pending in the US.
Johnson & Johnson began enrolling volunteers in the Phase 3 study. September 23. The researchers planned to enroll 60,000 participants from the United States and other countries.