AstraZeneca resumes U.S. COVID-19 vaccine trial and J&J prepares to do same next week

(Reuters) - AstraZeneca Plc has resumed the U.S. trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial as early as next week, the companies said on Friday.

AstraZeneca's U.S. trial was paused on Sept. 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 drugmaker 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 U.S. 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 of 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, Stoffels said.

AstraZeneca said that it is not unusual for some trial participants to fall ill during large scale vaccine trials but that the U.S. 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 U.S. Food and Drug Administration continued its investigation into the case.

Reuters earlier this week reported that the FDA had completed its review and that the AstraZeneca U.S. trial was set to resume as early as this week, citing four sources familiar with the situation.

AstraZeneca's vaccine is being developed along with researchers at Oxford University.

(Reporting by Munsif Vengattil and Carl O'Donnell; Editing by Anil D'Silva, Rosalba O'Brien and Grant McCool)

10/23/2020 21:04

News, Photo and Web Search