T.He has stopped studying Johnson and Johnson’s Covid-19 vaccine Due to an unexplained illness in the study participant.
A document sent to outside researchers conducting clinical trials of 1,000,000 patients states that a “break rule” has been found, the online online system used to register patients in the study has been shut down, and the Data and Safety Monitoring Board – an independent clinical trial – looks at patient safety. Retaining Committee – will be called. The document was obtained by STAT.
When contacted by STAT, J&J confirmed the cessation of the study, saying it was “due to an unexplained illness in the study participant.” The company declined to give further details.
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“We must respect the privacy of this participant. We will also learn more about this participant’s illness, and it is important to have all the facts before sharing additional information, “the company said in a statement.
J&J emphasized that the so-called adverse events – illness, accident and other bad medical outcomes – are an expected part of the clinical study, and also emphasized the distinction between study break and clinical hold, which is a formal regulatory action lasting longer. . Vaccine studies are not currently under clinical hold. J&J said that when it comes to contacting clinical holders for the general public, it does not usually inform the public about the study pause.
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The Data and Security Monitoring Board, or DSMB, called late Monday night to review the case. J and J said that in such cases “it is not always immediately clear” whether the participant who has experienced an adverse event received a study treatment or a placebo.
However, clinical trial suspensions are not uncommon – and in some cases last only a few days – they are generating outside attention in the race to test the vaccine against SARIZ-COVI-2, the virus that causes COVID-19.
Given the size of Johnson’s and Johnson’s trials, it’s not surprising that the study could be suspended, and another could happen if this is resolved, said a source familiar with the study.
“If we study, 000,000 people, it’s a small village.” “A lot of medical events happen in a small village.”
On September 8, a large study of the second Covid-19 vaccine, developed by AstraZeneca and Oxford University, was halted due to a suspicious reaction from a patient in the United Kingdom. It is believed that the patient has a spinal problem, transverse myelitis. The vaccine study resumed about a week after it was discontinued in the United Kingdom, and has since been resumed in other countries. It is, however, caught up in the United States.
Johnson and Johnson begin enrolling volunteers in their Phase 3 study 23 Sept.. Researchers plan to register 60,000 participants in the United States and other countries.
