On May 21, 2021, AstraZeneca announced that it had been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and older, to prevent COVID-19 caused by SARS-CoV-2.

The Japanese Ministry of Health, Labour and Welfare granted the approval based on positive Phase III efficacy and safety data from the Oxford University-led clinical trial programme in the UK, Brazil and South Africa, and a Phase I/II trial in Japan.