Johnson & Johnson, a US drug and household chemicals manufacturer disclosed yesterday, that it has paused the advanced clinical trials of its experimental coronavirus vaccine due to an unexplained illness in one of the volunteers.
According to the statement released by the company on the study titled ‘ENSEMBLE’, it says, ‘Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.’
‘Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.’
Earlier this month, Johnson & Johnson joined the list of vaccine makers in the US, and has since begun dosing up to 60,000 volunteers, marking the first big trial of a Covid-19 vaccination that may work after just one shot.
The company, however, did not reveal what the unexplained illness was, but the major focus is to find out if the vaccines cause dangerous side effects.
The company stated that, ‘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.’
‘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.’
‘Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events 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.’
Dr. Ashish Jha, Dean of the Brown University School of Public Health, opined by saying, ‘This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3.’
She proceeded by saying, ‘The Johnson & Johnson trial is the biggest trial of the vaccine that I know of — 60,000 people… within that trial you’d expect a few pauses.’
News of the halt was made known after AstraZeneca Plc, temporarily put a hold on the tests of its vaccine after a trial volunteer fell ill. And this makes it the second Phase 3 coronavirus vaccine trial to be paused in the US.
Johnson’s Phase 3 trial which started in September, is one of six coronavirus vaccines being tested in the US, and one of four in the most advanced, Phase 3 stage.
Jha, continued by saying, ‘We want the vaccine to be safe and we’ve got to let the process play out and it’s going to take a while.’
She added that, ‘To me it’s reassuring that companies are acting responsibly and pausing when they need to.’
Adenike Omosanya
Photo Credit: Politico and CNBC