• Johnson & Johnson had initially planned to enroll over 60,000 participants for its phase 3 clinical trials.
• Experts claim that clinical pauses are a common aspect and may last only a few days.

U.S.-based multinational pharmaceutical corporation Johnson & Johnson has reportedly paused the study of its COVID-19 vaccine candidate after it had an adverse effect in one of the participants. Sources close to the matter stated that the company has issued an investigation on the unexplained ailment in the participant.

Johnson & Johnson had initially planned to enroll over 60,000 participants in the U.S. as well as other countries for its phase 3 clinical trials. In this context, experts cite that given the size of the company’s COVID-19 vaccine trials, such pauses are a common aspect and may last only a few days.

Johnson & Johnson mentioned in a statement that accidents, illnesses and other adverse medical outcomes are a common part of a clinical study and its safety monitoring panel will review as well as determine the cause of the illness.

Johnson & Johnson also emphasized over the fact that its COVID-19 vaccine study is currently paused and not on a clinical hold. The American pharmaceutical giant added that it is not yet apparent whether the participant who suffered an adverse effect received the potential vaccine or a placebo.

For the record, British pharmaceutical company AstraZeneca plc had also kept its COVID-19 vaccine trials on hold earlier in September, after one of the study participants witnessed an unexpected reaction. Although the study resumed in the United Kingdom a week later, the trials are still kept on hold in the United States.

In other news, Indian biotechnology company Bharat Biotech International Ltd. has reportedly reduced the size of its phase-2 clinical study for COVID-19 vaccine candidate called Covaxin. According to experts, reducing the size of Covaxin’s clinical trial will allow Bharat Biotech to accelerate phase-2 study and possibly initiate the phase 3 trials eventually.

Source Credits –

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