Johnson & Johnson pauses COVID-19 vaccine trials due to unexplained illness in participant
13 October, 2020
Johnson & Johnson said on Monday (Oct 12) it has temporarily paused its COVID-19 vaccine applicant clinical trials because of unexplained illness in a report participant.
The participant's illness has been reviewed and evaluated by an unbiased data and safety monitoring board, in addition to the company's clinical and safety physicians, it said in a statement.
"Adverse events - illnesses, accidents, etc - even those that are serious, are an expected part of any clinical study, especially large studies," said the business.
"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 could be paused if an urgent serious adverse event that could possibly be related to a vaccine or study drug is reported, so there can be a careful overview of each of the medical information before deciding whether to restart the analysis."
Last week, the European Union announced it has sealed a handle Johnson & Johnson to provide up to 400 million doses of its potential COVID-19 vaccine, as the bloc builds up stocks amid a worldwide scramble to secure shots.
The offer is its third advance purchase contract with makers of COVID-19 vaccines after deals with AstraZeneca and Sanofi, bringing the number of doses secured by the EU because of its population of 450 million to at least one 1.1 billion.
Under the conditions of the deal, the 27 EU states will be able to order up to 400 million doses of the potential vaccine after it really is authorized by the EU medicine regulator.
To secure the vaccines, the EU made an undisclosed deposit to Johnson & Johnson, which confirmed the offer in a statement in which it reiterated plans to allocate up to 500 million additional doses to poorer countries from mid-2021.
Source: www.channelnewsasia.com
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