Federal health regulators have chose to allow the resumption of the US trial of a leading Covid-19 vaccine candidate from AstraZeneca and the University of Oxford, the Wall Street Journal reported on Friday (Oct 23), citing a person familiar with the matter and materials reviewed by it.
Reuters on Tuesday had reported that the US Food and Drug Administration had completed a review and that the trial was set to resume as early as this week, citing four sources familiar with the situation.
AstraZeneca, Oxford and US regulators were not immediately available for comment.
AstraZeneca's large, late-stage US trial has been on hold since Sept 6, after a participant in the company's UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
Trials in the United Kingdom, Brazil and South Africa resumed the previous month even as the US health regulator continued its investigation into the case.
AstraZeneca, which is developing the vaccine with Oxford University researchers, had been seen as a front-runner in the race to produce a vaccine for Covid-19, until its trials were put on hold to investigate the illness.
Early data from large-scale trials in the United States of vaccines from Pfizer and Moderna are expected some time next month.
Johnson & Johnson's late stage Covid-19 vaccine trial was paused the previous week to investigate an unexplained illness in a study participant.