Johnson & Johnson halts COVID-19 vaccine trial due to 'unexplained illness' in participant

Johnson & Johnson said on October 12 that it h temporarily paused Phase 3 clinical trial of its COVID-19 vaccine candidate after one of participants fell sick. In a statement released on official website,  American multinational corporation assured that re is “ greater priority than safety” of people and that it is committed to providing transparent updates of its clinical development process. However, it ded that study participant showcased an “unexplained illness” which is currently being reviewed and evaluated. 

Johnson & Johnson said, “We have temporarily paused furr dosing in all our COVID-19 vaccine candidate clinical trials, including Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, participant’s illness is being reviewed and evaluated by ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”

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This furr implies that 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 “verse 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. US-based pharmaceutical company said, that studies are halted due to an “unexpected serious verse event (SAE)”, to enable “a careful review of all of medical information before deciding wher to restart study.”

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Enrollment for phase 3 trails began in late Sept

J&J Phase 3 trial h started enrolling participants in late September and set a goal of recruiting up to 60,000 volunteers across more than 200 sites in 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 single dose in early trial sts. 

While global COVID-19 infections have surpassed 37.8 million as per Johns Hopkins University tally, J&J-developed COVID-19 vaccine was fourth vaccine candidate to have entered final phase of clinical trials. report published on medical website medRxiv h stated, “ safety profile and immugenicity after only a single dose are supportive for furr clinical development of [vaccine] 26.COV2.S at a dose level of 5x1010 vp, as a potentially protective vaccine against COVID-19.”

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