“Serious and unexpected adverse event”

Temporary stay of trial for another candidate vaccine anti-COVID-19. This is what the multinational pharmaceutical company is working on Johnson and Johnson and the stop was decided because one of the trial participants became ill without the experts having so far been able to find the causes. The rupture was reported to all researchers who care for the approximately 60,000 patients undergoing the trial. A similar stop has also occurred recently for the Oxford University vaccine candidate with Irbm and AstraZeneca, but everything was resolved within a few days and then the experimentation was resumed. This type of suspensions, in fact, are not unusual in experimental studies and mark the extreme attention to the drug study processes in the different phases.

“We have temporarily suspended the administration of additional doses in all of our clinical trials of the Covid-19 vaccine candidate, including the Phase 3 Ensemble study, due to an illness, the cause of which has not yet been defined, manifested by a study participant.” Johnson & Johnson clarified the company. Adding: “We must respect the privacy of this participant. We are also learning more about the adverse event and it is important to have all the facts clear before sharing more information.” Following “our guidelines, explains J&J, the adverse event was reviewed and evaluated by Ensemble’s independent Data Security Monitoring Board and our internal experts. ”

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Adverse events: illnesses, accidents, etc. – Even the most serious are an “expected component” of any clinical trial, especially large ones, specifies the company itself. Based on “our strong commitment to safety, all clinical trials conducted by Johnson & Johnson’s Janssen pharmaceutical companies, the company continues, have pre-defined guidelines.” These, he emphasizes, “ensure that our studies can be suspended if a serious and unexpected adverse event is reported that could be related to a vaccine or study drug, so that there can be a careful review of all medical information.” before deciding whether to restart the study. ‘

Serious and unexpected events, the company says, “are not uncommon in clinical trials, and it is reasonable to expect their number to increase in studies involving large numbers of participants.” Also, since many studies are placebo controlled, “it is not always immediately obvious whether a participant has received the study treatment or a placebo.” J&J also notes that there is a significant distinction between suspension of a study and regulatory suspension of a clinical study.

Stopping a study where the study sponsor suspends recruitment or dosing, he says, “is a standard aspect of a clinical study protocol. As outlined in the Ensemble study protocol, Johnson & Johnson has strong mechanisms in place to protect the safety of participants in its clinical trials. While the company always informs all researchers about the study, we generally do not publicly communicate study pauses. “The regulatory suspension of a clinical trial or suspension of study authorization, on the other hand,” occurs after the request. from a regulatory health authority, such as the US Food and Drug Administration (FDA). As stated in our transparency commitments, we proactively disclose any regulatory suspension of a major clinical trial. “

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Last update: October 14 at 07:52


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