NEW JERSEY (BLOOMBERG) - Johnson & Johnson said its Covid-19 vaccine study has been temporarily halted due to an unexplained illness in a trial participant, the second time that a front-runner developer has encountered this situation in the intensifying race for immunisation.
The New Brunswick, New Jersey-based company said in a statement late Monday the participant’s illness is being evaluated, and that it would share more information after investigation. J&J’s statement confirmed an earlier report by health-care news provider Stat that the study was paused.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate,” J&J said in its statement.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies.”
While pauses in late-stage testing is a routine event for the pharmaceutical industry, J&J’s interruption raises concern over safety issues as Covid-19 vaccine candidates have progressed at unprecedented speed this year.
AstraZeneca Plc last month temporarily stopped tests of its vaccine after a trial participant fell ill. That study has resumed in a number of countries but remains halted in the US.
J&J executives will likely face questions about the trial halt Tuesday morning during their presentation of third-quarter earnings.
Representatives for the US Food and Drug Administration could not immediately be reached by phone or email after business hours.
J&J’s setback is the latest reality check for a world anxiously awaiting a vaccine against the pandemic that has sickened more than 37 million.
It’s a reminder of how long it takes to bring a successful shot to the market, despite promises from politicians and governments that a Covid-19 fix is around the corner.
The pursuit of a vaccine has become a political topic, with some observers concerned that US President Donald Trump’s eagerness to see a vaccine authorised before the election could run counter to the scientific process.
While there are hundreds of Covid-19 vaccines being developed around the world, Johnson & Johnson is among a short list of vaccine makers which have progressed into final-stage human studies.
The company is dosing up to 60,000 volunteers in the first big trial of an Covid-19 inoculation that may work after just one shot.
AstraZeneca is still waiting for a decision from US regulators on whether it can resume tests in the country after halting global trials on Sept 6 due to concerns about a UK participant who became ill.
Developed with Oxford University, that experimental vaccine has seen trials resume outside the US in locations including the UK and South Africa.
https://news.google.com/__i/rss/rd/articles/CBMifGh0dHBzOi8vd3d3LnN0cmFpdHN0aW1lcy5jb20vd29ybGQvdW5pdGVkLXN0YXRlcy9qb2huc29uLWpvaG5zb24tY292aWQtMTktdmFjY2luZS1zdHVkeS1wYXVzZWQtZHVlLXRvLXVuZXhwbGFpbmVkLWlsbG5lc3MtaW7SAQA?oc=5
2020-10-13 02:22:30Z
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