Japan is set to authorize Pfizer Inc.’s COVID-19 vaccine for around 4 million children age 12 to 15 from as early as Monday, health minister Norihisa Tamura said Friday, following in the footsteps of the U.S. earlier this month.
A health ministry panel on Friday recommended easing the age restriction on when people can get the U.S. drugmaker’s shot — currently set at 16 years of age — without conducting an additional clinical trial in the country. Tamura said the move would take effect after the government amends its guidelines on the emergency use of the vaccine.
“I’d like children to be inoculated as soon as possible, so I’d like to ask local governments to streamline the system for that,” he told reporters.
The 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.
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 early next month, while the European Medicines Agency could authorize the vaccine for people in the same age group on Friday, reports say.
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 next month after its clinical trial of 3,732 volunteers age 12 to 17 showed that it was 100% effective against COVID-19.
Meanwhile, a clinical trial in the U.K. of the AstraZeneca vaccine on children has been halted amid worries over links to rare blood clots.
Currently, no Western COVID-19 vaccines are authorized for use below 12 years of age, but some manufacturers are looking to expand usage even further to overcome a gap in vaccinations for that age group.
Pfizer and BioNTech in March began administering its vaccines as part of a global trial for children age 6 months to 11 years old. It is evaluating the safety, tolerability and immunogenicity — a substance’s ability to trigger an immune response — in three age groups: children 6 months to 2 years old, those age 2 to 5 and those age 5 to 11. Moderna also began a randomized late-stage clinical trial for more than 6,700 children age 6 months to 11 in the U.S. and Canada in March.
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