AstraZeneca Covid-19 vaccine approved for emergency use in Japan

AstraZeneca's Covid-19 vaccine has been granted a special approval for emergency use in Japan for people aged 18 years and older, the company said on Friday.

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, it added in a statement.

Japan's Pharmaceuticals and Medical Devices Agency recommended that the use of Vaxzevria, formerly known as AZD1222, should be limited to adults and administered as two doses given four to 12 weeks apart, with an interval greater than eight weeks being preferable to maximise its efficacy.

“This dosing regimen was shown in clinical trials to be well-tolerated and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose,” AstraZeneca said.