Japan approves Pfizer COVID vaccine for children aged 5 to 11

Japan's health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11.

The vaccine, Comirnaty, is claimed to be the first in Japan to be approved for use in this age group. Once the Ministry of Health, Labor and Welfare grants special approval, Japan will join the UK and US in efforts to reduce the impact of COVID-19 in children.

Until now, the mRNA vaccine has only been available to individuals over the age of 12 in the country. However, with this approval, approximately seven million children will be eligible to receive a dose of the vaccine.

According to ministry officials, inoculations could begin as early as March once specific details of the roll-out are finalised.

"We'd like to carefully explain the safety (of the vaccine) and start inoculation as soon as possible to those who wish to receive it," Noriko Horiuchi, minister in charge of promoting vaccine roll-outs, said at a press conference.

"It is a big thing to have an inoculation option when some children are infected with the Omicron strain," she said.

While there are similarities in the active ingredients used to manufacture vaccines for both age groups, this version of the vaccine has been specifically developed for use in children.

According to the ministry, the Pfizer-BioNTech COVID-19 Vaccine for children aged five to 11 is administered three weeks apart as a two-dose primary series. It is a lower dose (10 micrograms) than is used for individuals 12 years of age and older (30 micrograms).

Clinical trial data from studies conducted by Pfizer in the US and other nations showed that the vaccine was 90.7% effective in preventing infections related to COVID-19 in children aged 5 to 11.

Moreover, while trial results did show side effects, including sore arms, fatigue and headaches in the patients the next day, these disappeared quickly, and there were no reported safety issues.

In February 2021, Pfizer's mRNA vaccine against COVID-19 became the first to gain formal approval for use in Japan.