Johnson & Johnson Aforesaid Monday t Had Quickly Hated Its COVID-19.
"We have quickly paused additional dosing altogether our Covid-19 immunizing agent candidate clinical trials, as well as the part three ENSEMBLE trial, thanks to Associate in Nursing unexplained ill health during a study participant," the corporate aforesaid during a statement.
The pause suggests that the enrollment system has been closed for the 60,000-patient test whereas the freelance patient safety committee is convened.
J&J aforesaid that serious adverse events (SAEs), like accidents or diseases, area unit "an expected a part of any clinical study, particularly giant studies." Company tips permit them to pause a study to work out if the SAE was associated with the drug in question and whether or not to resume the study.
The J&J part three trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across over two hundred sites within the U.S. and around the world, the corporate and also the U.S. National Institutes for Health (NIH), that is providing funding, said.
The U.S. has given J&J regarding $1.45 billion in funding beneath Operation Warp Speed. The immunizing agent is predicated on one dose of a cold-causing animal virus, changed so it will not replicate, combined with a locality of the new coronavirus known as the spike supermolecule that it uses to invade human cells.
J&J used constant technology in its Ebola hemorrhagic fever immunizing agent that received promoting approval from the EU Commission in July.
Pre-clinical testing on Macaca mulatta catarrhine monkeys that were printed within the journal Nature showed it provided complete or near-complete protection against infection within the lungs and nose.
Like many alternative parts three trials that area unit current, its primary objective is to check whether or not the immunizing agent will forestall symptomatic Covid-19. In September, trials on the coronavirus immunizing agent developed by AstraZeneca Associate in Nursingd Oxford were paused when a GB volunteer developed unexplained ill health.
The immunizing agent is one in every of the foremost advanced Western comes, having previously been tested on tens of thousands of volunteers comprehensive. Trials resumed earlier this month in Japan however not us, wherever AstraZeneca is functioning with regulators.