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

AstraZenecaAstraZeneca'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.(1)

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "We continue to expand global access to our vaccine and today’s approval brings us one step closer to providing Vaxzevria to the people of Japan who urgently need protection from coronavirus. We are proud to have produced a vaccine for the world, which is playing a leading role in the global fight against the pandemic, with more than 400 million doses now supplied by AstraZeneca and sub-licensees to 165 countries."

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.

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

About Vaxzevria

Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

1. Vosey, M., et al (2021) Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet. 397(10269): 99-111.

Most Popular Now

AstraZeneca COVID-19 vaccine Vaxzevria authorised …

AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisat...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companie...

Takeda announces approval of Moderna's COVID-19 va…

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under...

Sanofi and GSK initiate global Phase 3 clinical ef…

Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recomb...

Sanofi and GSK COVID-19 vaccine candidate demonstr…

The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who h...

European Commission approves Venclyxto-based combi…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidi...

Novartis reaches milestone delivery of 1 billion c…

Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was s...

COVID-19 mRNA vaccines are immunogenic in pregnant…

Pregnant women with symptomatic COVID-19 have a higher risk of intensive care unit admissions, mechanical ventilation and death compared to non-pregnant reproductive age ...

Why are some COVID-19 vaccines working better for …

MSU researcher is studying, raising awareness about the role of sex in the efficacy of vaccines that make use of nanomedicine. If there's one take-home message for the...

Rogue antibodies wreak havoc in severe COVID-19 ca…

The development of antibodies to the COVID-19 virus has been the great long-term hope of ending the pandemic. However, immune system turncoats are also major culprits in ...

New vaccine platform: 'Two-one replicon-and-VLP-mi…

To stop the current SARS-CoV-2 pandemic, vaccines of high quality, safety, and efficacy are required. Scientists of the Paul-Ehrlich-Institut and the Ludwig Maximilian Un...

COVID-19 monoclonal antibodies reduce risk of hosp…

Monoclonal antibodies, a COVID-19 treatment given early after coronavirus infection, cut the risk of hospitalization and death by 60% in those most likely to suffer compl...