AstraZeneca US COVID-19 Vaccine Trial to Resume Upon Completion of FDA Review

AstraZeneca Plc (Cambridgeshire, England) is set to resume its US COVID-19 vaccine trial as early as this week after the US Food and Drug Administration finishes its review of a serious illness in one of the study volunteers, according to a report by Reuters.

AstraZeneca is conducting trials of its adenovirus vector-based COVID-19 vaccine candidate, AZD1222, developed by the University of Oxford (Oxford, UK). In September, AstraZeneca had confirmed that a participant in the Phase 3 trial of the company’s experimental COVID-19 vaccine candidate developed a serious spinal inflammatory disorder called transverse myelitis, forcing it to halt the study. While regulators in the UK, Brazil, India and South Africa later allowed AstraZeneca to resume its clinical trials in those regions, the FDA had widened its investigation of the serious illness arising in the company’s COVID-19 vaccine study.

According to Reuters’ sources, the FDA is requiring the researchers conducting the trial to add information about the incident to consent forms signed by the study participants. The sources have been told that AstraZeneca’s COVID-19 vaccine trial could resume later this week, although it was unclear how the FDA would characterize the illness in the study volunteer.

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