A COVID-19 vaccine study by Johnson & Johnson has been put on hold after one of the study’s participants had an ‘unexpected illness.’
An independent safety monitoring board will review the patient’s case, according to the company.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” Johnson & Johnson said.
Johnson & Johnson has not said what type of illness the participant of the 60,000-person trial developed. The age nor the gender have also not been revealed.
It added that the company has guidelines for unexpected serious adverse events that can put studies on hold.
“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 stated.
“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.
AstraZeneca also put its phase three COVID-19 vaccine on hold after a woman in the UK reportedly suffered a rare spinal cord injury.
