‘Unexpected illness’ halts Johnson & Johnson trial
COVID-19 vaccine clinical trials by Johnson & Johnson in the US have come to a halt after a participant developed an “unexplained illness”.
In a statement, the pharmaceutical giant said further dosing in all COVID-19 candidate vaccine clinical trials had been “temporarily paused”.
This includes phase three of its Janssen Pharmaceutical Companies trial called “Ensemble”, involving up to 60,000 volunteers across three continents.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the Ensemble independent Data Safety Monitoring Board as well as our internal clinical and safety physicians,” Johnson & Johnson said.
It said all clinical studies have prespecified guidelines to ensure they may be paused “if an unexpected serious adverse event 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 company said.
“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.”
Johnson & Johnson last week sealed a deal with the European Union for 200 million doses of its vaccine “following approval or authorisation from regulators”, with the option of another 200 million doses.
According to The New York Times’ coronavirus vaccine tracker, there are 11 vaccines in phase three large-scale efficacy tests worldwide including the AstraZeneca and University of Oxford study in the UK.
Prime Minister Scott Morrison has signed a “Letter of Intent” for supply of that vaccine, if trials are successful, and pledged in August jabs would be free for “every single Australian”.
The AstraZeneca late-stage trials were suspended for a week in September due to an illness in a study participant in Britain, but resumed after getting the green light from safety watchdogs.