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Johnson & Johnson Pauses COVID Vaccine Trial as Participant Falls Sick

The trial had 60,000 participants.
by Agence France Presse
Oct 13, 2020
Photo/s: National Cancer Institute via Unsplash
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WASHINGTON -- Johnson & Johnson said Monday it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.

"We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the  Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant," the company said in a statement.

The pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

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J&J said that serious adverse events (SAEs) are "an expected part of any clinical study, especially large studies." Company guidelines allowed them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.

The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world.

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The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

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