The COVID-19 vaccine trial of Johnson & Johnson has been halted as a study participant had fallen due to an unexplained illness, on Monday. The halts include all clinical trials, Phase 3 ENSEMBLE trial. The online system enrolling the volunteers, the COVID-19 patients for the 60,000-patient clinical trial as a part of the study has been closed and the independent committee watching the safety of patients involved in the clinical trial has been called for a meeting.
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J&J said that Serious Adverse Events (SAEs) are "an expected part of any clinical study, especially large studies”. Illness, accidents, bad medical outcomes are the expected part of a clinical study. The guidelines allow halting the trial to study the unexpected illness and to determine whether the drug has caused the SAE. The phase 3 trials have started in September for 60000 patients from 200 cities across the globe including Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa. When asked about the illness to the patient, J&J refused the reveal about the current status as it may affect the patient’s privacy.
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It is to be noted AstraZeneca and Oxford University is also on hold due to the mysterious reaction in a patient in the United Kingdom. The patient reported transverse myelitis, a spinal cord problem. However, the study resumed in a week in UK and is still hold in the USA. Halting and Resuming trial is quite normal in a study and the trials will begin soon.
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