The Phase 1/2 clinical trials for the COVID-19 vaccine AZD1222 have resumed in Japan following a meeting with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
On 6 September, a standard evaluation procedure prompted a voluntary pause for vaccination across all global trials to allow an evaluation of safety data by an independent committee. Their guidelines have been endorsed in Brazil, India, the United Kingdom and now in Japan by international regulators, who have found that the trials are safe to resume.
“The Phase 1/2 clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan.“
To facilitate the analysis of the details needed to decide on the resumption of the US trial, AstraZeneca will continue to collaborate with the Food and Drug Administration (FDA).