US pharmaceutical giant suspends covid vaccine tests

The American pharmaceutical giant  Johnson & Johnson has  suspended clinical testing of its Covid-19 vaccine after one of its participants became ill.

“We have temporarily halted the administration of new doses in all our clinical trials of the Covid-19 vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in a study participant,” the company said in a statement on Tuesday October 13.

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.

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 a goal of enrolling up to 60,000 participants at more than 200 locations in the United States and around the world.

The other countries where the tests were carried out are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

J&J is the tenth laboratory globally to perform phase 3 tests against Covid-19, and the fourth in the United States.

The company received $1.4 billion from the US government, as part of an initiative to develop a vaccine against the virus that has killed over  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 its Ebola vaccine that was approved for marketing by the European Commission in July.

Tests on monkeys that were published in the journal Nature showed that the vaccine gave complete or almost complete protection against a virus infection in the lungs and nose.