An undisclosed illness in one of their trial participants has caused the shutdown of Johnson & Johnson’s COVID-19 vaccine trials. The company announced the halt late in the day October 12, 2020, in a press 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. “Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines.
“These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”
The press release also noted that “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.” The declined to elaborate, citing patient confidentiality concerns.
AstraZeneca temporarily halted its COVID-19 vaccine clinical trials in September 2020 after a study volunteer developed transverse myelitis, an inflammatory condition affecting the spinal cord.
SOURCES:
CNN Health October 12, 2020
Johnson & Johnson October 12, 2020
The New York Times September 8, 2020