Johnson & Johnson’s paused Covid-19 vaccine due participant’s “unexplained illness” is related to the shot.
The company said in a statement on Monday evening that illnesses, accidents. And other so-called adverse events “are an expected part of any clinical study, especially large studies”. But that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
The pause is at least the second such hold to occur among several vaccines. That have reached large-scale final tests in the United States. The company declined to reveal any more details about the illness, citing the participant’s privacy. Temporary stoppages of large medical studies are relatively common.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Company’s performed such tests 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 to determine if the person received the vaccine or a placebo. The halt was first reported by the health news site STAT.
AstraZeneca and Oxford University are doing Final-stage testing of a vaccine. And it would be remains on hold in the US as officials examine whether an illness in its trial poses a safety risk. Johnson & Johnson stopped such trial when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.
Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other Covid-19 vaccine candidates in the US require two shots.
