Clinical trials of AstraZeneca and Oxford University’s experimental COVID-19 vaccine have resumed in Japan, almost a month after being put on hold due to the illness of a British volunteer, while discussions with U.S. authorities continue.
The British drugmaker said on Friday the early-to-mid-stage trial for the vaccine against the coronavirus resumed in Japan after consultations with the national health regulator, the Japanese Pharmaceuticals and Medical Devices Agency.
Global trials of the vaccine, called AZD1222 or ChAdOx1 nCoV-19, were put on hold on Sept. 6 after a study participant fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
Trials in the U.K., Brazil, South Africa and India had already restarted, but U.S. trials remain paused as regulators widened their probe.
AstraZeneca has called the halt a standard review procedure, and a document posted online by Oxford university last month stated the illness may not have been associated with the vaccine.
However, the incident has drawn focus on the safety of candidates being developed in the race for a successful vaccine against the illness caused by the coronavirus, which has claimed more than a million lives globally.
The U.S. Food and Drug Administration broadened its investigation of the illness in the volunteer, and would look at data from earlier trials of similar vaccines developed by the same scientists, three sources said.
In Friday’s statement, AstraZeneca stressed that safety of the participants was of “paramount importance” and that it was applying the highest standards of conduct in trials.
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