CAMBRIDGE, United Kingdom: AstraZeneca said on Friday (Oct 2) clinical trials of its experimental COVID-19 vaccine resumed in Japan, while adding that it was in talks with regulators on data needed to restart studies in the United States, where they remain halted.
Several global trials of the vaccine, AZD1222, were put on hold last month after an unexplained illness in a study participant. While most trials have resumed, US trials are still on pause as regulators widened their probe, Reuters reported on Wednesday.
The British drugmaker said the early-to-mid-stage trial for the vaccine candidate against the novel coronavirus resumed in Japan after consultations with the national health regulator, the Japanese Pharmaceuticals and Medical Devices Agency.
Trials in the UK, Brazil, South Africa and India had already restarted.
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 novel coronavirus which has claimed more than a million lives globally.
The US Food and Drug Administration (FDA) 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 told Reuters.
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.
Sources had told Reuters that the data requested by the FDA for one of the most advanced COVID-19 vaccine candidates in development was expected this week.