The trial was stopped due to “unexplained illness in a study participant,” said the firm (Representational)
Washington, United States:
Johnson & Johnson said Monday that it had temporarily halted its Covid-19 vaccine trial because one of its participants had fallen ill.
“We have temporarily stopped additional dosing in all of our Covid-19 vaccine candidate clinical trials, including the ENSEMBLE Phase 3 trial, due to unexplained illness in a study participant,” the company said in a statement.
The hiatus means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent committee on patient safety is convened.
J&J said that serious adverse events (SAEs) are “an expected part of any clinical trial, especially large studies.” The company’s guidelines allowed them to pause a study to determine whether the SAE was related to the drug in question and whether to resume the study.
J & J’s phase 3 trial had begun recruiting participants in late September, aiming to enroll up to 60,000 volunteers at more than 200 sites in the US and around the world.
The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
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