Johnson & Johnson Suspends New Corona Vaccine Trials! Subject Has Unexplained Illness | TechNews 科技 新 报

It was reported that Johnson & Johnson, a candidate for a vaccine against coronary pneumonia (COVID-19, commonly known as Wuhan pneumonia), clinical trials were reported to have been temporarily suspended (study pause) due to unexplained pain in a subject.

STAT News exclusively reported on the 12th that external investigators responsible for conducting 60,000 clinical trials recently received a document stating that the “hold clause” has reached the threshold and the online website used has also been closed. to recruit test patients. A meeting will be held with the Data and Security Monitoring Board (DSMB) to discuss related matters.

This document was obtained exclusively by STAT, and Johnson also confirmed that the experiment was suspended, arguing that “it was impossible to explain why a subject was ill.” Johnson declined to provide additional details. In addition to respecting the privacy of patients, you must also understand the cause and consider all aspects before sharing information with the public.

Johnson emphasized that so-called negative events (that is, the subject’s illness, accidents, and other adverse medical outcomes) are expected for clinical trials. Suspension of clinical trials is different from the trial being considered non-executed (clinical suspension). “Non-execution” is a formal action taken by the competent authority and has a long duration. Johnson & Johnson clinical trials are not currently in a “no-run” state.

If the experiment is deemed prohibited, Johnson and Johnson will generally reveal it to the public, but if the experiment is only temporarily suspended, there will be no outside communication.

The Data and Safety Oversight Committee held a meeting later on the 12th. Johnson said it is not immediately known whether the subjects who had a negative reaction were vaccinated or placebo.

Johnson & Johnson began recruiting volunteers for the third phase of clinical trials on September 12. The researchers plan to recruit 60,000 people in the United States and other countries.

(This article has been reprinted with permission from MoneyDJ News; the source of the first image: Flickr / Open Grid Scheduler / Grid Engine CC BY 2.0)

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