Johnson & Johnson’s Covid-19 Vaccine Tests Stopped After Participant’s Illness | Vaccine

According to a document sent to the external researchers conducting the clinical trial with 60,000 patients, a “regulatory breakdown” will be followed, the online system used to enroll patients in the study and the data monitoring board will be shut down. safety, an independent body ensures the safety of patients in the clinical trial – was convened.

In an official statement, Johnson & Johnson’s notes that “adverse events – illnesses, accidents, etc. – even severe ones are an expected part of any clinical trial, especially large studies ”and that the patient’s illness is being“ analyzed and evaluated by the Board of Directors. ENSEMBLE (DSMB) independent data security monitoring, as well as by our internal security and clinical physicians. ”

The company also says that patient privacy must be respected and that since you are still learning more about the disease from this participant, it is important to have all the facts before sharing additional information.

Immunization, whose official name is Ad26.COV2.S, was developed by the pharmaceutical company Janssen Pharmaceuticals, which belongs to the J&J group. The immunization was the fourth to obtain authorization for phase 3 tests in Brazil, in August. In September, the company announced that it would begin the third stage worldwide, with 60,000 volunteers. In Brazil, according to Anvisa, there will be 7 thousand participants.

On September 29, preliminary and partial results indicated that the vaccine was safe and induced an immune response even after a single application.

The results were for a part of the participants in phases 1 and 2, which were carried out jointly. They had not yet been reviewed by other scientists, a necessary requirement for publication in a scientific journal, but they were available in an online repository.

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