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U.S. drugmaker Pfizer Inc. on Monday formally authorized the use of its COVID-19 vaccine for around 4 million children age 12 to 15 in Japan, following similar moves overseas to allow adolescents to be vaccinated.

The pharmaceutical giant revised its guidelines to lower the age restriction in Japan from the previous 16 to 12. The amendment also enabled undiluted, thawed vials of its COVID-19 vaccine to be stored at refrigerator temperature for a longer period of time, from the previous five days to up to one month.

Following the Pfizer announcement, a health ministry panel decided Monday to add children age 12 through 15 to the list of those eligible to receive COVID-19 vaccine jabs for free, in accordance with the Preventive Vaccination Law.

Pfizer’s move followed a recommendation by a separate health ministry panel on Friday that the age restriction on when people can get the U.S. drugmaker’s shot be eased, with an additional clinical trial in the country not deemed necessary for the move.

However, just because children age 12 through 15 are now approved for vaccinations, it doesn't mean they will immediately start being inoculated.

But the health ministry said during the panel's discussions that with the lowered age restriction, adolescents in this age group who have underlying health conditions will now be prioritized for vaccinations in the same way that those who are older will be. Prime Minister Yoshihide Suga said Friday that some municipalities where the rollout is progressing smoothly are expected to start administering jabs for the general population, including those with pre-existing conditions, as early as June.

Another point of contention raised by the panel is whether to make it mandatory for children age 12 through 15 to be accompanied by their parents or guardians when they get their shots. The panel also discussed the feasibility of creating a system through which adolescents can receive the shots en masse on school premises.

Older people wait to receive a dose of a COVID-19 vaccine at Fujita Health University gymnasium, a newly opened large-scale coronavirus disease vaccination center in Toyoake, Aichi Prefecture, on May 24. | KYODO
Older people wait to receive a dose of a COVID-19 vaccine at Fujita Health University gymnasium, a newly opened large-scale coronavirus disease vaccination center in Toyoake, Aichi Prefecture, on May 24. | KYODO

Japan’s move comes after the U.S. Food and Drug Administration (FDA) lowered the minimum age for the vaccine, developed by the U.S. drugmaker and Germany’s BioNTech SE, to 12 on May 10. The headline results from the final phase clinical trial of 2,260 adolescents showed in March that the jab was 100% effective and “well tolerated” with no serious concerns over safety.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement after the May 10 decision.

Ahead of the U.S., Canada’s regulator authorized the move on May 5, becoming the first country to do so for that age group. Germany has also decided to offer the shots to adolescents age 12 to 15 from June 7, while the European Medicines Agency authorized the vaccine for people in the same age group on Friday.

Moderna Inc.’s vaccine, which was authorized for emergency use in Japan on May 21, could also be OK’d for more people in Japan as well in the next few months. The U.S. biotech firm said on Tuesday it would file an application for lowering the minimum age to 12 from 18 with the FDA and other regulators around the world early in June, after its clinical trial of 3,732 volunteers age 12 to 17 showed that it was 100% effective against COVID-19.

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