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The hiatus means that the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
WASHINGTON – Johnson & Johnson said Monday it had temporarily stopped its COVID-19 vaccine test because one of its participants had become 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 that the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
J&J said that serious adverse events (SAEs), such as accidents or illness, are “an expected part of any clinical trial, especially large studies.” The company’s guidelines allow 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 company and the National Institutes of Health. (NIH), which is to provide funding, he said.
The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
With the move, J&J became the 10th manufacturer globally to conduct a Phase 3 trial against Covid-19, and the fourth in the US.
The United States has given J&J about $ 1.45 billion in funding under Operation Warp Speed.
The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called spike protein that it uses to invade human cells.
J&J used the same technology in its Ebola vaccine, which received marketing approval from the European Commission in July.
Preclinical tests in rhesus macaque monkeys that were published in the journal Nature showed that it provided complete or almost complete protection against virus infection in the lungs and nose.
Like several other phase 3 trials that are underway, its main goal is to test whether the vaccine can prevent symptomatic Covid-19.
In September, trials on the coronavirus vaccine developed by AstraZeneca and the University of Oxford were halted after a UK volunteer developed an unexplained illness.
The vaccine is one of the most advanced Western projects and has already been tested on tens of thousands of volunteers around the world.
Trials resumed earlier this month in Japan, but not in the United States, where AstraZeneca is working with regulators.
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