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REUTERS: Johnson & Johnson said on Monday (Oct 12) that it temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant.
The participant’s illness is being reviewed and evaluated by an independent safety and data monitoring board, as well as the company’s safety and clinical physicians, it said in a statement.
“Adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical trial, especially large studies,” the company said.
“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have pre-specified guidelines.
“These ensure that our studies can be paused if an unexpected serious adverse event is reported that could be related to a vaccine or study drug, so there may be a careful review of all medical information before deciding whether to restart the study.” .
READ: Potential EU COVID-19 Vaccine Doses Exceed 1 Billion With Johnson & Johnson Deal
Last week, the European Union announced that it signed an agreement with Johnson & Johnson to supply up to 400 million doses of its possible COVID-19 vaccine, as the bloc accumulates reserves amid a global fight to secure vaccines.
The deal is its third advance purchase contract with COVID-19 vaccine manufacturers following agreements with AstraZeneca and Sanofi, bringing the number of EU-insured doses for its population from 450 million to 1.1 billion.
Under the terms of the agreement, the 27 EU states will be able to order up to 400 million doses of the potential vaccine after it is authorized by the EU drug regulator.
To secure the vaccines, the EU made an undisclosed initial payment to Johnson & Johnson, which confirmed the deal in a statement reiterating plans to allocate up to 500 million additional doses to the poorest countries from mid-2021. .
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