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US drugmaker Johnson & Johnson said Monday that temporarily stopped the clinical trial of your vaccine against covid-19 because one of its participants fell ill.
“We have temporarily halted the administration of new doses in all of our clinical trials of the covid-19 vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in a study participantThe company said in a statement.
The hiatus means the online enrollment system was closed for the 60,000-patient clinical trial, while the independent patient safety committee is convened.
J&J said that serious adverse effects were “An expected part of any clinical trial, especially a large one”. Based on company guidelines, they can stop a study to determine if the adverse effect was due to the drug in question and if the study can be resumed.
Phase 3 of the Johnson & Johnson study began recruiting volunteers in late September, with the goal of enroll up to 60,000 participants in more than 200 locations in the United States and the world.
The other countries where the tests were performed are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
J&J is the tenth laboratory in the world to carry out Phase 3 tests against covid-19, and the fourth in the United States.
The company received 1.45 billion dollars from the US government, within the framework of an initiative to develop a vaccine against the virus that has killed almost 215,000 people in the country.
The vaccine is based on a single dose of an adenovirus that causes influenza, modified so that it does not replicate, combined with a part of the new coronavirus that it uses to invade human cells.
J&J used the same technology for your Ebola vaccine which was approved for marketing by the European Commission in July.
Tests in monkeys that were published in the journal Nature showed that the vaccine granted complete or almost complete protection against a virus infection in the lungs and nose
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