Johnson & Johnson vaccine enters phase 3 1:05
(CNN) ––
Pharmaceutical Johnson & Johnson said on Monday that it paused the advanced clinical trial of its experimental vaccine against coronavirus, due to an unexplained illness in one of the volunteers.
"Following our guidelines, the participant's illness is being reviewed and evaluated by ENSEMBLE's independent Data Security Monitoring Board (DSMB), as well as by our internal safety and clinical physicians," said the company in a statement.
ENSEMBLE is the name of the study.
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"Adverse events - illnesses, accidents, etc. - even those that are serious are an expected part of any clinical trial, especially large studies," Johnson & Johnson added.
Johnson & Johnson's Janssen division is developing the injection.
The company did not detail what the unexplained illness was.
However, one goal of clinical trials is to determine whether vaccines produce dangerous side effects.
The tests stop when these consequences appear.
Also, while doctors check if the disease may be related to the vaccine or if it is a coincidence.
"Serious adverse events are not unusual" in vaccine trials, says Johnson & Johnson.
“Based on our strong commitment to safety, all clinical studies conducted by Johnson & Johnson's Janssen Pharmaceutical Companies have pre-specified guidelines.
These ensure that our studies can be paused if an unexpected serious adverse event (SAE) is reported.
Which may be related to a vaccine or the study drug.
So a careful review of all medical information can be done before deciding whether to restart the study, ”the company explained.
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“We must respect the privacy of this participant.
We are also understanding more about this participant's illness.
And it is important to have all the facts before sharing additional information, ”the company added.
'Serious adverse events are not unusual in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials with large numbers of participants.
Also, as many trials are placebo controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo, 'he added.
The second clinical trial to be suspended in the US
The drugmaker said there is a "significant distinction" between a study pause and a regulatory suspension of a clinical trial.
"A study pause, in which the study sponsor stops recruiting or dosing, is a standard component of a clinical trial protocol," said Johnson & Johnson.
“The regulatory pause of a clinical trial is a requirement of a regulatory health authority, such as the US Food and Drug Administration (FDA).
As outlined in our transparency commitments, we proactively disclose any regulatory suspension of a critical clinical trial. "
AstraZeneca trials still on hiatus in US 1:07
This is the second phase 3 trial for a coronavirus vaccine to be halted in the United States.
The AstraZeneca vaccine trial was suspended last month due to a neurological complication in a volunteer in the UK.
While the trial has resumed there and in other countries, it remains on hold in the United States while the FDA investigates.
Johnson's phase 3 trial began in September.
It is one of six coronavirus vaccines being tested in the US Also, one of four in the most advanced stage of Phase 3. It requires only one dose of vaccine, so federal officials have said they expect that the tests may compete a little faster than other vaccines.
Among them, those manufactured by Moderna and Pfizer, which require two doses.
Covid-19Johnson and JohnsonPandemicCoronavirus vaccine