‘Unexplained Illness’ Puts Johnson & Johnson Coronavirus Vaccine Study On Pause
A coronavirus vaccine study by Johnson & Johnson has been put on pause after one of the study’s participants had an “unexpected illness.”
An independent safety monitoring board will review the patient’s case as will internal clinical and safety physicians, the company said in a Monday evening news release.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” Johnson & Johnson said, adding that the company has guidelines for unexpected serious adverse events that can put studies on pause while they are being investigated.
“SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo,” the news release read, using the acronym for serious adverse events.
Johnson & Johnson has not said what type of illness the participant of the 60,000-person trial encountered. Further details, including the age and the gender of the participant, have also not been revealed.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said.
News about the pause comes just weeks after pharmaceutical giant AstraZeneca put its phase three COVID-19 vaccine on hold after a woman in the United Kingdom reportedly suffered a rare spinal cord injury. AstraZeneca resumed its study days later.
Author: Zachary Halaschak
Source: Washington Examiner: ‘Unexplained illness’ puts Johnson & Johnson coronavirus vaccine study on pause