J&J discontinued COVID-19 vaccine testing due to participant’s illness
Johnson & Johnson said Monday that it had suspended clinical trials of its COVID-19 vaccine candidate due to an unexplained illness among study participants.
Participants ’illnesses are reviewed and assessed by the company’s clinical and safety physicians in addition to the Independent Data and Safety Monitoring Board.
J&J, which reported quarterly financial results on Tuesday morning, said such breaks are common in large endeavors, which involve tens of thousands of people. The “Study Pause” in giving a dose to a vaccine candidate is different from the “regulatory hold” required by health officials. Current case break. However, the movement of J&J follows a similar approach by Astrogeneca PLC. In September, AstraZeneca developed the final phase tests of its experimental coronavirus vaccine with the University of Oxford, due to an unexplained illness in a UK study participant.
Although trials have resumed in the UK, Brazil, South Africa and India, the U.S. The investigation is still under regulatory review.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said in an email that it could take days to a week to gather information that “everyone is alert to what happened to Astrogenica.” “It has to be a serious adverse event. If it’s like prostate cancer, uncontrolled diabetes or heart attack – they can not stop it for those reasons. It’s likely to be a neurological event,” he said.
