U.S. drugmaker Pfizer Inc.'s Japan unit said Thursday it is in talks with the government about applying for approval of its COVID-19 vaccine for use in children age 5 to 11.

The move follows the overwhelming backing on Tuesday by the U.S. Food and Drug Administration’s advisory committee for lowering the minimum age for the vaccine from the current 12 to 5, paving the way for formal authorization for the shot's use in 28 million children there from early November.

Pfizer said the company is in talks with regulatory authorities in Japan but added it cannot comment on the timing or other details of the application or its approval.

The health ministry authorized lowering the age limit to 12 from 16 on June 1, less than a month after the U.S. endorsed the change, without conducting an additional clinical trial in Japan. The administration of Prime Minister Fumio Kishida is hinting that it will again act swiftly to make the vaccine available to the younger demographic, which accounts for around 7.4 million children and about 6% of the population.

“If Pfizer takes the necessary pharmaceutical procedures, we would confirm (the vaccine’s) efficacy and safety and make an appropriate response,” Yoshihiko Isozaki, deputy chief Cabinet secretary, told reporters Wednesday.

To apply for fast-track approval in Japan, Pfizer would need to submit data from its clinical trial. The late-stage trial conducted in the U.S., Finland, Poland and Spain has shown a favorable safety profile and efficacy of 90.7% in preventing infection, even when the highly contagious delta variant was the prevalent strain.

A health worker holds a vial containing the Pfizer-BioNTech COVID-19 vaccine at a vaccination center in Germany on Feb. 2. | AFP-JIJI
A health worker holds a vial containing the Pfizer-BioNTech COVID-19 vaccine at a vaccination center in Germany on Feb. 2. | AFP-JIJI

The dosage of Pfizer’s shots given to younger children is one-third of that administered to people age 12 and over, with doses given three weeks apart. The Japan Pediatric Society has said that vaccinating healthy children is an important step but added that it should be approached carefully.

The education and health ministries have sent a notice to municipalities saying that the government does not recommend mass vaccinations at schools, due to the difficulty of adequately explaining the vaccines to parents and a tendency for children to face peer pressure. The same would likely apply for children age 5 to 11, as children age 15 and younger are required to have a parental signature to get a COVID-19 shot, experts say.

Some parents may hesitate to have their younger children vaccinated amid worries over side effects. But given that there’s an elevated chance of myocarditis and related symptoms in young unvaccinated people with COVID-19 — a condition that has been observed in limited cases after a young person has received a shot — there’s no denying the benefits of getting vaccinated, said Dr. Tetsuo Nakayama, a project professor at the Kitasato Institute for Life Sciences and director of the Japanese Society of Clinical Virology.

“It’s important for adults who often deal with young children, such as school teachers, but who haven’t received the COVID-19 vaccine yet to get the shot,” he said. “There’s a limit to what young children can do now for public hygiene purposes, such as masking-up, but the vaccine would give them a means to prevent infection, so the benefits from getting the vaccine are high.”

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