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On October 12, local time, Johnson and Johnson temporarily halted trials of its new coronavirus (COVID-19) vaccine because of an unexplained illness in one participant, according to STAT News, a U.S. medical news site.
A document sent to outside researchers running the clinical trial, which included 60,000 study participants, said adverse reactions among study participants had met the "pause rule" and that the online system used to recruit study participants had been shut down and the Data and Safety Monitoring Committee, which oversees patient safety in clinical trials, would be convened.
Johnson and Johnson said in a statement that it was currently working to learn more about the participant's own medical history and that it was important to have all the facts before publishing more information to protect patient privacy.
Johnson and Johnson stressed that so-called adverse events are expected events in clinical studies, and also highlighted the difference between research suspension and clinical shelving, a formal regulatory measure that lasts longer.
vaccine research has not yet been clinically studied.
Johnson and Johnson said that while it usually communicates clinical reservations to the public, it does not usually notify the public that clinical trials are suspended.
, johnson and Johnson research COVID-19 vaccine JNJ-78436735 I / IIa phase research results have been published, single-dose vaccine has good tolerance and high immunogenicity.
phase 3 trial of the vaccine began recruiting participants in late September, covering more than 200 sites in the United States and around the world, and recruiting up to 60,000 volunteers.
Johnson and Johnson became the 10th manufacturer in the world and the fourth in the United States to conduct a phase III trial of COVID-19.
In fact, this is not the first time a COVID-19 vaccine trial has been suspended, and a month ago large-scale clinical studies of the Covid-19 vaccine at AstraZeneta and Oxford University were suspended on suspicion of adverse reactions by a British participant believed to have spinal transverse spinal corditis.
has resumed in other countries since the vaccine was suspended in the UK for about a week, although trials of the vaccine in the US are still on hold.
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