AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has 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.

Japan’s Pharmaceuticals and Medical Devices Agency recommends that the use of Vaxzevria should be limited to adults and administered intramuscularly as two 0.5 mL 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.

Production of the vaccine in Japan is already underway, and the first doses are expected to be available in the coming weeks.

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 80 countries across six continents and has also received Emergency Use Listing from the World Health Organization, which accelerates the pathway to access in up to 142 countries through the COVAX Facility.

Vaxzevria can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months, and administered within existing healthcare settings.

Source:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-covid-19-vaccine-vaxzevria-authorised-for-emergency-use-in-japan.html