2nd COVID-19 vaccine trial paused over unexplained illness
New Brunswick (US): A late-stage study of Johnson & Johnson's COVID-19 vaccine candidate has been paused while the company investigates whether a study 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 US.
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. Few are made public in 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 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.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the US 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. 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 vaccine candidates in the US require two shots.
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16 patients shifted after fire at private hospital near Bengaluru
Bengaluru (PTI): Sixteen patients admitted at a private hospital in Rajanakunte near here were shifted after a minor fire broke out at the three-storey building on Tuesday, fire officials said.
No one has sustained any injury, they said.
The fire department said a call about the fire at the hospital was received at 9.15 am following which six fire tenders were pressed into service.
According to the department, fire broke out at a lab in the basement of the 50-bedded private hospital. Though the fire did not spread to the ground and the three upper floors of the building, the entire hospital was engulfed in thick smoke causing panic and uneasiness among patients, staff and visitors at the hospital.
A total of 16 patients who were admitted in the hospital, including the two in ICU, were immediately shifted to the nearest hospital.
“All patients are stable. No one sustained any injuries. Because of the thick smoke, some of them complained of uneasiness and suffocation. They were immediately shifted to the nearest hospital,” a senior fire official said.
The fire was, however, extinguished by 11 am, the fire officials said, adding that the exact cause of fire is being ascertained.
#Breaking#Fire breaks out at Raksha Health Care hospital in #Bengaluru’s Rajanakunte area.
— TOI Bengaluru (@TOIBengaluru) May 7, 2024
Fire service personnel have reached the spot.
Casualties/injuries are yet to be ascertained. pic.twitter.com/CQxXzUhVQy
