Emerging Diseases, Johnson & Johnson’s COVID-19 Vaccine Clinical Trials Suspended – Scientifically Based and Practical Latest Pharmaceutical Info

Pharmaceutical Magazine – Studies on the Johnson & Johnson Covid-19 vaccine have been suspended due to an unexplained disease in study participants.

A document sent to outside investigators running a clinical trial of 60,000 patients stated that the “quitting rule” had been met, that the online system used to enroll patients in the study had been shut down, and that data and safety monitoring agencies – an independent committee overseeing patient safety in clinical trials – will be established.

Quoted from STATnews, J&J confirmed the study lag, saying it was due to “an unexplained disease in study participants.” The company declined to provide further details

“We must respect the privacy of these participants. We also learned more about this participant’s illness, and it is important to know all the facts before we share additional information, “the company said in a statement.

J&J emphasizes that so-called adverse events – illness, accidents, and other adverse medical outcomes – are an expected part of clinical studies, and also emphasizes the difference between study breaks and clinical suspensions, which are formal regulatory measures that can last longer. Vaccine studies are not currently under clinical scrutiny.

J&J said that although it usually communicates clinical examinations to the public, it usually does not inform the public about study breaks.

The data and security monitoring agency, or DSMB, gathered late Monday to review the case.

J&J said that in cases like these it was “not always immediately apparent” whether participants who experienced adverse events received the study treatment or a placebo.

Although stopping clinical trials is not uncommon – and in some cases only lasts a few days – it has created enormous attention in the race to test a vaccine against SARS-CoV-2, the virus that causes Covid-19.

Given the size of the Johnson & Johnson trial, it is not surprising that one lag study could occur, and another one could occur if these were resolved, sources familiar with the study said.

“If we do a study of 60,000 people, it is a small village incident,” said the source.

“In the small village there are a lot of medical incidents going on.” he continued.

On September 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and the University of Oxford was postponed due to a suspected adverse reaction in a patient in the United Kingdom.

It is believed that the patient has transverse myelitis, a problem of the spinal cord. Vaccine studies resumed about a week after being temporarily suspended in the United Kingdom, and have since restarted in other countries as well. However, it is still stifled in the United States.

Johnson & Johnson began enrolling volunteers in the Phase 3 study on September 23. The researchers plan to enroll 60,000 participants in the United States and other countries.

Sumber : Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/

–