Clinical Japan’s MHLW approves AstraZeneca and Moderna Covid-19 vaccines

Japan’s MHLW approves AstraZeneca and Moderna Covid-19 vaccines


Japan’s Ministry of Health, Labour, and the Welfare department (MHLW) has approved Moderna’s COVID-19 mRNA vaccine and Vaxzevria, the Covid-19 vaccine of AstraZeneca for emergency use.

Vaxzevria has been recommended for the vaccination of people of 18 years of age or older against Coronavirus.

Vaxzevria, which is developed by the collaboration of Vaccitech and the University of Oxford, is a vaccine based on adenovirus containing the spike protein genetic code of SARS-COV-2.

MHLW has approved the Vaxzevria vaccine based on the favorable safety and efficiency data from the phase 3 clinical trials conducted in the United Kingdom, Spain, and Brazil by the University of Oxford, and also phase 1/phase 2 clinical trials conducted by Japan.

Adults can get two IM (Intramuscular) doses of Vaxzevria with an interval of 4-12 weeks, as per the guidelines of the Pharmaceutical and Medical Devices Agency of Japan.

The Research and Development executive vice-president, AstraZeneca Pharmaceuticals, Mene Pangalos 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.”
Vaxzevria is currently being manufactured in Japan and its first doses will be available shortly in the market.

The vaccine, previously referred to as AZD1222, has been approved for emergency use in approximately 80 countries and is listed by WHO (World Health Organization) as an emergency use vaccine.
The Moderna’s mRNA Covid-19 vaccine (TAK-919), currently known as COVID-19 vaccine Moderna IM injection, has been approved by MHLW based on the results of phase 3 clinical trials.

Furthermore, the data obtained from phase 1/2 clinical trial conducted by Takeda pharmaceutical, which would market the vaccine soon, was evaluated by MHLW.

Takeda is planning to provide 50 million shots of the Covid vaccine to Japan, by the first half of 2021, according to an agreement made between MHLW and Moderna in October 2020.

Moderna along with Samsung Biologics has signed a deal providing production and distribution services, under which Samsung Biologics will be responsible for the mass production of the Covid-19 vaccine of Moderna in South Korea.

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