Covid 19 coronavirus: second vaccine trial stopped due to ‘unexplained illness’

A late-stage study of Johnson & Johnson’s Covid-19 vaccine candidate has been halted while the company investigates whether a study participant’s “unexplained illness” is related to the injection.

The company said in a statement late Monday that illnesses, accidents and other so-called adverse events “are an expected part of any clinical trial, especially large studies,” but that its doctors and a safety monitoring panel would try. determine what could have caused the disease.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by Ensemble’s independent Data Safety Monitoring Board, as well as our internal safety and clinical physicians,” said Johnson & Johnson.

The pause is at least the second of its kind to occur among several vaccines that have reached full-scale final testing in the US.

The hiatus includes phase three of their Janssen Pharmaceutical Companies trial called “Ensemble,” involving up to 60,000 volunteers on three continents.

The company declined to disclose further details about the disease, citing the participant’s privacy.

Johnson & Johnson last week sealed an agreement with the European Union for 200 million doses of its vaccine “after approval or authorization by regulators,” with the option of another 200 million doses.

Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but work to make a coronavirus vaccine has raised the stakes on these types of complications.

Companies should investigate any serious or unexpected reactions that occur during drug testing.

Since these tests are performed on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is determining whether the person received the vaccine or a placebo.

The halt was first reported by the health news site STAT.

The final stage test of a vaccine made by AstraZeneca and the University of Oxford remains on hold in the US as officials examine whether a disease in their test poses a safety risk.

That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company said. Testing of that company has been restarted elsewhere.

Johnson & Johnson aimed to enroll 60,000 volunteers to demonstrate whether its single-dose approach is safe and protects against coronavirus. Other candidate vaccines in the US require two injections.