Johnson & Johnson said on October 12 that it had temporarily paused the Phase 3 clinical trial of its COVID-19 vaccine candidate after one of the participants fell sick. In a statement released on the official website, the American multinational corporation assured that there is “no greater priority than safety” of the people and that it is committed to providing transparent updates of its clinical development process. However, it added that the study participant showcased an “unexplained illness” which is currently being reviewed and evaluated.
Johnson & Johnson said, “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”
This further implies that the online enrollment system of more than 60,000 patient clinical trial has been closed and an independent patient safety committee is convened. Saying that such “adverse events” including illness and accidents are expected in a clinical study, Johnson & Johnson said that all clinical studies of its COVID-19 vaccine candidate have prespecified guidelines. The US-based pharmaceutical company said, that the studies are halted due to an “unexpected serious adverse event (SAE)”, to enable “a careful review of all of the medical information before deciding whether to restart the study.”
The J&J Phase 3 trial had started enrolling participants in late September and set a goal of recruiting up to 60,000 volunteers across more than 200 sites in the US, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa. Earlier, Johnson & Johnson’s COVID-19 candidate was reported to have shown a strong immune response with the single dose in the early trial stages.
While global COVID-19 infections have surpassed 37.8 million as per Johns Hopkins University tally, J&J-developed COVID-19 vaccine was the fourth vaccine candidate to have entered the final phase of clinical trials. The report published on the medical website medRxiv had stated, “The safety profile and immunogenicity after only a single dose are supportive for further clinical development of [vaccine] Ad26.COV2.S at a dose level of 5x1010 vp, as a potentially protective vaccine against COVID-19.”