Question

Discuss the news article, and write a summary

"Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'."

By Maggie Fox, CNN

Answer 1

The vaccine development arm of Johnson & Johnson's Janssen vaccine paused the clinical trial after one of the volunteers developed unexplained illness. The trial conducted by Janssen vaccine called ENSEMBLE has recruited about 60,000 volunteers and the trial is in Phase 3. In the current pandemic situation vaccine development is critical and so is the race to develop the first COVID 19 vaccine that is safe, efficacious and free from side effects.

During the conduct of clinical trials if any participants displays any signs of unrelated illness, the trial is halted to study the reason behind the unusual illness and its link or causality with the vaccine administration. The trail is halted in order to stop additional dosing and keep other study participants from harm and maintain their safety. This is a standard practice in clinical trials conduct. The illness is required to be determined by independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians to ensure if it is related or unrelated to the vaccine given.

If the illness is related then vaccine development is re-evaluated and if unrelated then the trial can proceed on the clearance report to safety board. The other important aspect is that, it is unknown if the patient was given the vaccine or placebo dose as it is a double blind trial where neither the patient or physician knows the exact administered vaccine or sham given. This is done to avoid any bias and determine the efficacy is not linked to placebo effect.

So on final safety study and determination of the safety profile and the exact reason behind the unknown illness of the study participant the ENSEMBLE study Johnson & Johnson's Janssen vaccine for development of COVID 19 vaccine is paused keeping in mind the utmost safety and well being of the study participants.