Johnson & Johnson has decided to temporarily put the clinical trials of its COVID-19 vaccine on hold after an unexplained illness in a study participant.
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,” a statement from Johnson and Johnson said.
It added, “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”
In September this year, AstraZeneca too had paused the trials of COVID-19 vaccine, being developed with the University of Oxford, due to an unexplained illness in a UK study participant. A report by Reuters said that whilst AstraZeneca has resumed the trials in the UK, Brazil, South Africa and India, the US trial is still on hold pending a regulatory review.
The COVID-19 pandemic has killed more than one million people across the globe.
LIVE UPDATES on this and other big stories of the day will appear below:
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18:01 PM: A 35-year-old woman set herself on fire near the UP Vidhan Bhawan allegedly over a family dispute. Police personnel present at the spot rescued her: Police. (PTI)
17:12 PM: The UP government’s politically motivated narrative of justifying and protecting perpetrators of crimes against women has only emboldened criminals across the state: Congress leader Priyanka Gandhi Vadra
This man’s three daughters aged 17, 10 & 8 were asleep in their home when someone entered and threw acid on them.
The UP government’s politically motivated narrative of justifying and protecting perpetrators of crimes against women has only emboldened criminals across the state. pic.twitter.com/WgThvDlYqB
— Priyanka Gandhi Vadra (@priyankagandhi) October 13, 2020
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— Gonda Police (@gondapolice) October 13, 2020
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