The study carried out by the pharmaceutical company Johnson & Johnson of the vaccine against Covid-19 has been suspended due to an inexplicable disease that one of the participants presented, it was learned last night from information from the pharmaceutical company itself.
In addition, it was learned that a document sent to external researchers who are running the clinical trial with 60,000 patients indicates that a “pause rule” has been met.
It is also stated that the online system used to register the study participants has been closed and that the data and safety control board, an independent entity that ensures the safety of patients in the clinical trial, would be summoned.
Johnson & Johnson posted on its website: “We have temporarily stopped additional dosing in all of our Covid-19 vaccine candidate clinical trials, including the Phase 3 Ensemble trial, due to unexplained illness in one study participant.”
Furthermore, Johnson & Johnson explained that “the participant’s condition is being reviewed and evaluated by Ensemble’s independent Data Security Monitoring Board (DSMB), as well as by our clinical and intern physicians. security”.
Among other details, the pharmaceutical company noted that “adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical trial, especially large studies.” In this sense, he ratified his commitment to the safety of those who are part of the trials.
“We must respect the privacy of this participant. We are also learning more about the disease from this participant and it is important to have all the facts before sharing additional information,” the pharmacist added.