J&J Pauses COVID-19 Vaccine Trials Due To Unexplained Illness In Participant

J&J Pauses COVID-19 Vaccine Trials Due To Unexplained Illness In 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".

A statement from the company on Monday announced that the advanced clinical trial of the vaccine - which is being developed by Johnson & Johnson's vaccine arm, Janssen Pharmaceutical Companies - has been paused following a participant's illness.

The recruitment of volunteers for phase 3 of the Johnson & Johnson clinical trials began at the end of September.

The Phase 3 trial of Johnson & Johnson's COVID-19 vaccine candidate has been paused as the company investigates what it says is a study participant's "unexplained illness".

The company did not release details or symptoms of the person's illness, and only said that researchers are evaluating the subject to see if the illness is related to their medication.

"The news that Johnson & Johnson has paused its vaccine trial has not gone entirely unnoticed, but the market has learned to live with the ups and downs of product development over the past few months, with the reaction to this kind of news much more muted than during the summer", said Chris Beauchamp, chief market analyst at IG. "We just need to let the sponsor and the safety board do their review and let us know their findings".

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According to the New York Times, trial pauses are "often lifted quickly after the illness is investigated and deemed not to be a serious safety risk".

Experts said safety issues must be investigated and are one reason late-stage trials can not be rushed, even if Trump has repeatedly claimed that a vaccine will be ready before Election Day on November 3. While the trial resumed in the United Kingdom and in other countries, it remains halted in the USA while it is being probed by the Food and Drug Administration investigators. However, the report said that the participant is expected to recover.

The halt was first reported by the health news site STAT.

If approved, the jab would be available for emergency use authorisation in early 2021 on a not-for-profit basis.

The vaccine, first licensed by Russian authorities for domestic use in August, is now being tested on 40,000 volunteers in Moscow as part of a late-stage trial known as Phase III. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.

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