Johnson and Johnson announced on Monday that its COVID-19 vaccine trial has been put on hold after one of the volunteers began to show signs of an “unexplainable sickness”. The study which is called ENSEMBLE, like other vaccine trials, is conducted to check how suitable and effective Johnson’s vaccine is. When a volunteer falls ill, the trial will be paired for doctors to make research on the connection, if any, between the vaccine and the volunteer’s condition as the drug company is doing now.
“Our guidelines stipulate that the volunteer’s condition must be properly and carefully examined and reviewed.” the company said in his statement.”ENSEMBLE Independent Data Safety Monitoring Board (DSMB) and our internal clinical and safety experts are reviewing the volunteer’s condition for any connection to the vaccine.”
The company said they are very committed to the safety of trial volunteers and of ultimate users. They said the clinical trials followed strict protocols and safety guidance to guarantee reliable results. “One of our protocols is to immediately pause a study in the case of a Serious Adverse Event (SAE) that might have any connection to a trail or vaccine,” they stated. “So we carry out a critical examination to determine if we should resume the trial.”
The company has not provided any information about the illness to protect the volunteer’s privacy. The company also stated that during large experimental trials, such incidents cannot be completely avoided.
“We will share more information about the volunteer’s condition when we have more data, we must however ensure that the volunteer’s privacy is not tampered with,” Johnson & Johnson stated.
The company also that it was not clear if the sick volunteer received the vaccine or a placebo.
Dr. Ashish Jha, Dean of the School of Public Health at Brown University admitted that such an incident is expected. The dean stated that Trump’s administration’s order to have a vaccine before the election is even more preposterous considering these types of pauses. She stated that with 60,000 people participating in ENSEMBLE, a few pauses are nothing unusual. The company also announced that the pause is a decision of those in charge of the study and not a regulatory hold that is usually enforced by public health agencies such as the FDA.
The company started Phase 3 of the trial in September. The trial is one of the six trials being conducted by U.S companies and one of the four of the six trials which has entered the third phase. It is the second Phase 3 trial to be paused after AstraZeneca paused its vaccine trial in September. The Johnson trial which will be administered in one dose is preferred by federal government officers over others which will need two doses.