Health Care

Johnson&Johnson moves to buoy investors over paused COVID vaccine trial

Johnson&Johnson moves to buoy investors over paused COVID vaccine trial”

In a conference call Tuesday morning to discuss its finances, Johnson & Johnson said it had learned about a participant's illness on Sunday evening and immediately informed an independent data and safety monitoring board.

J&J said that such temporary halts due to "adverse events - illnesses, accidents, etc", are very common, especially in large trials, adding that the studies conducted by the J&J subsidiary have prespecified guidelines which foresee the pause of studies "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".

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine - which uses a similar technology - due to a participant falling ill.

Johnson & Johnson said it was working to learn more about the participant's illness and said it would not share any more information at this time. However, management indicated that "while the company is blinded, the DSMB has the right to unblind, which seems to suggest the pause recommendation could come from an unblinded analysis from DSMB".

This is not the first coronavirus vaccine trial to be placed on pause.

Johnson and Johnson's vaccine candidate is a single-dose approach.

More news: Have your say: Should England have had a 'circuit breaker' national lockdown?

Besides J&J, drugmaker AstraZeneca had to put its phase 3 coronavirus-vaccine trial on hold in early September because of spinal inflammation in a British participant. The AstraZeneca study resumed a few days later in the United Kingdom and elsewhere, though it remains on hold in the US, reports NPR.

The money is part of an overall World Bank Group (WBG) package of up to $160 billion through June 2021 created to help developing countries battle the novel coronavirus pandemic. Other vaccine candidates in the US require two shots.

"This could be a second case of adenoviral vaccine to spur safety concerns", said Bryan Garnier analyst Olga Smolentseva.

The World Bank said Tuesday that it approved $12 billion for developing countries to finance the purchase and distribution of Covid-19 vaccines, tests, and treatment.

"This is likely to be a neurological event", he said.

The vaccine is now in Phase 3 of trials, which has involved some 30,000 participants in the U.S. as well as in the UK, Brazil and South Africa.



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