News Coronavirus AstraZeneca resumes US coronavirus vaccine trial

AstraZeneca resumes US coronavirus vaccine trial

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AstraZeneca has resumed the US trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial early next week.

The news signalled progress against the coronavirus, which has infected more than 41 million people globally and comes 10 days before the US presidential election where the issue of how the pandemic is being fought is seen as crucial to the result.

AstraZeneca’s US trial was paused on September 6 after a report of a serious neurological illness, believed to be transverse myelitis, in a participant in the company’s UK trial. J&J paused its large, late-stage trial last week after a study participant became ill and the company said an independent safety panel was investigating.

J&J said on Friday that the safety panel, called a Data and Safety Monitoring Board, has recommended that the drug maker resume trial recruitment after finding no evidence that the vaccine caused the volunteer to fall ill.

J&J expects to resume its trial in the US on Monday or Tuesday of next week and remains on track to produce data from the trial on the vaccines’ effectiveness by the end of 2020 or early 2021, J&J’s chief scientific officer Paul Stoffels said.

J&J is also in discussions with other regulators to resume a trial outside the United States, the company said.

So far, the medical board has not identified a clear cause for the patients’ illness. J&J cannot reveal any details about the patient’s sickness because of patient privacy rules, Mr Stoffels said.

AstraZeneca said that it is not unusual for some trial participants to fall ill during large scale vaccine trials but that the US Food and Drug Administration has reviewed all safety data from the trials globally and deemed it safe to continue testing the vaccine.

AstraZeneca trials in the United Kingdom, Brazil and South Africa resumed last month even as the US Food and Drug Administration continued its investigation into the case.

 

 

The decision to continue in Brazil came after health authority Anvisa confirmed the death of a volunteer in a clinical trial of the vaccine, developed by AstraZeneca and Oxford University.

-with AAP