Drugmaker Johnson & Johnson has halted the advanced clinical trial of its experimental COVID-19 vaccine because a participant developed an unexplained illness. The company has issued a statement saying that trials have been paused and guidelines are being followed to review the illness of the participants by internal clinical and safety physicians. The illness of the study volunteer is also being reviewed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB). ENSEMBLE is the name of the study. “Such adverse events or even much more serious in nature are considered expected part of such large clinical studies.” The trail has been paused comes close on the heels of AstraZeneca PLC pausing trials of a vaccine that it’s developing in collaboration with the University of Oxford. AstraZeneca had cited similar reasons. Though it has started trials in the UK, the study remains suspended in the United States.
The vaccine is being developed by Johnson & Johnson’s vaccine arm. The company has so far refused to talk about the unexplained illness but one of the important focuses of the clinical trials was to find if the shot can cause dangerous side effects. The company has stopped the trials but doctors are trying to find out if the illness is just a coincidence or can be linked to the vaccine. The company said that the Janssen Pharmaceutical Companies are committed to the safety of the volunteers. “These guidelines ensure that the company halts such studies in the face of any unexpected serious adverse event (SAE) in connection with the vaccine. It is then carefully studied before reaching to a conclusion whether to restart the study,” the company said.
The company emphasized that it is extremely important to respect the privacy of participants. “We are trying to learn more about the illness and the company will share information in this regard only after we will have all the facts.” It is not clear for how long the trials will be halted, but this demonstrates the tough road ahead for developing vaccines for COVID-19.