WASHINGTON DC: The research on a vaccine for COVID-19 by Johnson and Johnson has been paused due to unexpected illness in one of the participants. Outside researchers, performing clinical trials over 60,000 patients, have received a document regarding “pausing rule”. The document stated that the online platform for enrolling the patients for the study is closed. A Data and Safety Monitoring Board, which is an independent committee that watches over the safety of patients in clinical trials, would be convened.
The company has declined to provide any other further details and said that adverse events like accidents, illness and others are an expected part of the procedure. They also addressed the difference between study pause and clinical holds, where latter is the formal action which may last longer than study pause.
Johnson and Johnson have attracted a lot of attention in their race to produce a vaccine for SARS-CoV2. The company said that the study pauses are bound to happen and can occur again in the future, given the size of the trials.
In September, AstraZeneca and Oxford University, two of the biggest vaccine studies, saw a similar case of study pause due to suspected adverse reaction in a patient. After some time, it was found that the patient was suffering from Transverse Myelitis, a spinal cord problem. Research was resumed after a week and has been started in all other countries except the United States of America (USA).