Johnson & Johnson clinical trial of its COVID-19 vaccine was paused after a volunteer came down with an unexplained illness. The company did not disclose what the illness was, citing the participant´s privacy. The New Jersey-based company says the participan´s illness is being reviewed and evaluated by an independent board.
In a statement, the company said, “At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standars and our own high ethical and scientific principles.”
Temporary stoppages of large medical studies are relatively common. Few are made public during typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done for 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 to determine if the person received the vaccine or a placebo.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial 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 has said
Johnson & Johnson were aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.