CHICAGO/WASHINGTON • The US trial of AstraZeneca's Covid-19 vaccine is expected to resume as early as this week after the United States Food and Drug Administration (FDA) has completed its review of a serious illness in a study participant, according to four sources.
AstraZeneca's late-stage US trial has been on hold since Sept 6, after a participant in the firm's British 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 characterise the illness. The agency declined to comment.
The FDA 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.
British regulatory officials previously reviewed the illness and determined that 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 Britain, according to a draft of the updated consent form.
"In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare Products Regulatory Agency) recommended that vaccinations should continue," the draft form stated. "Close monitoring of the affected individual and other participants will be continued."
Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there.
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 (J&J) last week paused its Phase III Covid-19 vaccine trial to investigate an unexplained illness in a study participant.
J&J noted last week that its "study pause" was voluntary. By contrast, AstraZeneca's trial is on regulatory hold, which is imposed by the health authorities.
REUTERS
