AstraZeneca’s COVID-19 vaccine trial in the United States is expected to resume as early as this week after the US Food and Drug Administration completed its review of a serious illness in a study participant, sources told Reuters on Tuesday.
AstraZeneca’s large, late-stage US trial has been on hold since September 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.
The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week. It was unclear how the FDA would characterize the illness, they said.
An FDA spokeswoman declined to comment.
The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.
UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume in the UK, according to a draft of the updated consent form shared with Reuters.
AstraZeneca, which is developing the vaccine with Oxford University researchers, had been seen as a frontrunner 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, according to Reuters.
Last week, Johnson & Johnson paused the trial of its COVID-19 vaccine due to an unexplained illness in a study participant.
A J&J spokesman on Tuesday said the study remains on pause as the company continues its review of medical information before deciding to restart the trial. J&J noted last week that its “study pause” was voluntary. By contrast, AstraZeneca’s trial is on “regulatory hold,” which is imposed by health authorities.