Johnson & Johnson have become the latest to put their Covid-19 vaccine trial on pause due to an unexplained illness appearing in one of the participants. AstraZeneca and the University of Oxford also made headlines recently when they had to pause their trial for the same reason. The AstraZeneca trial, however, has resumed in Canada and Europe, just not the US.
For Johnson & Johnson, however, a document was recently sent out to outside researchers who were running the clinical trial – which involved 60,000 patients – that claimed a “pausing rule” had been met and the trial was to stop immediately until a proper investigation into the sick individual has been performed.
The online system that’s been used to enroll patients in the study has been officially closed and all data that’s already been collected from various committees would be collected and analyzed together. Johnson & Johnson recently spoke with the media about putting their trial on pause but provided little information based on the fact that they themselves are still working on the investigation.
“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 did emphasize in their statement that adverse events like this happening during a clinical study for a vaccine made for a virus the world knows so little about, is normal. In fact, the AstraZeneca trial has had to pause a few times now due to unexplained illnesses appearing in certain participants. These issues that cause the trials to come to a halt are typically isolated incidents and have to do with the individuals personal health over anything else.
They also emphasized the difference between a “study pause” and a “clinical hold” when it comes to vaccine trials. A clinical hold is a formal regulatory action that can cause a vaccine trial to stop for a long-time. This incident, however, falls more under the study pause category, as the company is projecting to restart the trial this week.
Late Monday evening the data and safety monitoring board, or DSMB, for the Johnson & Johnson trial met to review the case involving this sick participant. When it comes to these illnesses it’s not always immediately clear what the cause is, but the first thing the first thing the DSMB needs to determine is if the patient received a version of the vaccine, or a placebo.
The fact that this trial is one of the biggest in the world also means that these pauses are likely to occur more than once. Again, AstraZeneca has had to take multiple pauses and their trial involves about half the participants as Johnson & Johnson. A source recently spoke with the media about how common these pauses are.
“If we do a study of 60,000 people, that is a small village. In a small village there are a lot of medical events that happen.”
Johnson & Johnson initially began enrolling volunteers for Phase 3 of their clinical trial for a Covid-19 vaccine on September 23rd. Researchers initially planned on enrolling 60,000 participants from all over the world and are planning to still hit that number as well.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at firstname.lastname@example.org.