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Japan weighs approving Moderna's COVID-19 vaccine for ages 12 to 17
The vaccine would become the second available to adolescents in the country after Pfizer Inc. received approval in late May.
www.japantimes.co.jp
Japan is in the process of approving Moderna Inc.'s COVID-19 vaccine for use on adolescents between the ages of 12 and 17, the government's top spokesman said Friday.
A panel at the Ministry of Health, Labor and Welfare will consider lowering the age limit for the shot, which has already been given the green light for people 18 and older, "if the efficacy and safety is confirmed and the guidelines are amended," Chief Cabinet Secretary Katsunobu Kato said at a news conference.
Moderna's Japanese partner Takeda Pharmaceutical Co. is already in talks with the ministry, Kato said, setting up the vaccine to become the second available to adolescents in the country after Pfizer Inc. received approval in late May.
On Thursday, Moderna said it has asked the U.S. Food and Drug Administration for emergency use authorization of the shot for ages 12 to 17 after clinical trials on nearly 2,500 subjects showed a 100 percent efficacy rate with no significant health concerns to date.
The U.S. biotechnology firm said it has also requested approval from Canadian and European drug authorities and "will file with regulatory agencies around the world for this important younger age population."
Japan is currently administering COVID-19 vaccines to health care workers and people 65 and older, with the so-far sluggish rollout to ramp up significantly in the coming days as it expands to all age groups.
Pfizer already approved
Japan approves Pfizer's COVID-19 vaccine for ages 12-15
The Japanese government approves Pfizer Inc.'s COVID-19 vaccine for 12- to 15-year-olds, the first shot to be made available to children in the country.
english.kyodonews.net