Reporter |
According to Bloomberg, on October 12, Johnson & Johnson paused its COVID-19 candidate vaccine study due to an unexplained illness in a trial participant.
Johnson & Johnson’s Candidate COVID-19 Vaccine Began Recruiting Volunteers for Phase III Clinical Trials on September 23. According to documents sent by Johnson & Johnson to clinical trial institutions, the clinical trial protocol stipulated that the emergence of an unexplained illness met the study’s “pause criteria,” thereby halting the recruitment of participants for the clinical trial. The online system used for recruiting participants has been closed, and a committee responsible for overseeing patient safety is currently monitoring the study data and safety profile.
According to a report by STAT, a healthcare industry media outlet, Johnson & Johnson confirmed the suspension of the study but did not provide further details. The company stated that adverse events are an expected part of clinical trials, and serious adverse reactions are not uncommon in large-scale clinical studies. Furthermore, as this was a placebo-controlled trial, it could not be determined whether the participant had received the investigational vaccine injection.
Johnson & Johnson also emphasized the distinction between a “research pause” and a “clinical hold,” with the latter being a formal regulatory measure that can last longer; however, the vaccine is not currently under a “clinical hold.”
A source familiar with the matter stated in an interview with STAT that, given the scale of the trials conducted by Johnson & Johnson, the suspension of the study was not surprising. The study, launched on September 23, was designed to enroll 60,000 volunteers. “If we study 60,000 people, various medical events will inevitably emerge.”
Additionally,This also follows the suspension of AstraZeneca and the University of Oxford’s Phase III clinical trials of their COVID-19 vaccine in September after a participant developed an unexplained illness.the second Phase III trial of the COVID-19 vaccine was paused. Currently, AstraZeneca's vaccine has resumed clinical trials in Brazil, India, and other regions, but the trial remains suspended in the United States.
Furthermore, the vaccines suspended by Johnson & Johnson and AstraZeneca are both adenovirus vector-based COVID-19 vaccines. These two incidents have sparked concerns within the industry regarding the adenovirus vector technology platform for COVID-19 vaccines.