Japan panel approves Pfizer shot for children age 5 to 11 as omicron spreads

A health ministry panel backed the Pfizer-BioNTech coronavirus vaccine Thursday for children age 5 to 11, with the government preparing to kick-start the rollout in March, as the omicron variant raises fresh concerns about how COVID-19 affects children.

The health ministry is expected to formally issue fast-track approval as early as Friday to ease the age restriction for receiving the Pfizer shot — currently set at 12 years of age, a ministry official said. Prime Minister Fumio Kishida reiterated last week that his administration will act swiftly to make the vaccine available to the 7.2 million children (about 6% of the population) that are in that age group.

Moderna Inc.’s vaccines have also been authorized for use in Japan for people age 12 and above, while AstraZeneca’s jab has been approved for people age 40 and over, in principle. Some countries started giving vaccines to children age 5 to 11 months ago, with the U.S. beginning its rollout of the Pfizer shot for that cohort in November.

The health ministry initially planned to start the rollout for young children next month, but that plan was delayed as imports of vaccines won’t begin until February. In Japan, a separate vaccine formula will be used from the one used for people age 12 and above.

The late-stage trial on nearly 2,300 children age 5 to 11 conducted in the U.S. and other countries using a third of the dose administered to people age 12 and above has shown efficacy of 90.7% in preventing infection, even when the highly contagious delta variant was the prevalent strain. Even against the omicron variant, which is even more transmissible, the vaccine has displayed proven efficacy in preventing infection, symptomatic disease and serious illness, health ministry officials say.

Across the globe, the U.S., Canada and Israel recommend all eligible children get vaccinated, while France and Germany recommend the vaccine for children with an increased risk of severe illness, among other factors. The top five most common side effects reported were pain, fever, fatigue, headache and myalgia, according to V-safe, a voluntary U.S. vaccine safety app.

More than 8 million doses of Pfizer’s vaccine had been administered to children age 5 to 11 in the U.S. by late December. According to a survey of more than 41,000 V-safe participants, around 10% were unable to attend school due to adverse events but only 1% needed medical care.

In Japan, children age 15 and younger are required to have a parental signature to get a COVID-19 shot, but some parents have voiced worries over side effects. A survey conducted last September by the National Center for Child Health and Development showed that more than 70% of guardians of elementary school students and younger children would want or were leaning toward having their children get vaccinated, while around 20% of them were leaning against the idea. Meanwhile, the same survey showed that about 50% to 60% of elementary school students would want or were leaning toward getting vaccinated, while 30% to 40% were leaning against it.

The quantity of messenger RNA included in 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 says it is important to vaccinate adult workers who work with children first and that vaccinating children with underlying diseases is expected to prevent severe illness.

“We believe that vaccination of healthy children age 5 to 11 is just as meaningful as vaccination of healthy children age 12 and older,” it said in a statement issued Wednesday.

Dr. Tetsuo Nakayama, a project professor at the Kitasato Institute for Life Sciences, recommends vaccinations for not only children with conditions that increase the likelihood of severe symptoms of COVID-19 but for healthy children as well. COVID-19 infections can be physically and mentally draining for unvaccinated people, Nakayama noted. Even in cases where the vaccine fails to prevent infection, it can still prevent serious illness, he added. He warned against mandatory vaccination, however, saying that it is necessary for children and caregivers to fully understand the advantages and potential adverse reactions of vaccines beforehand.

COVID-19 deaths have been reported among children age 5 to 11 in the U.S. and other countries, but so far no deaths have been reported in that demographic in Japan. That, however, will change given that the omicron variant has been spurring record numbers of cases in recent days, said Nakayama, who also serves as director of the Japanese Society of Clinical Virology.

“The role of vaccines is that children are able to live healthy lives because they are protected by the vaccines that they have received since they were little,” he said. “For example, the Japanese encephalitis vaccine is recommended to everyone as part of the government’s routine vaccination program. There are hardly any patients with Japanese encephalitis now. But if you are infected, the virus can cause severe encephalitis — which can lead to permanent disability later on.

“In that sense, we have to think of the COVID-19 vaccine in the same way.”

The health ministry panel on Thursday also approved the use of Chugai Pharmaceutical’s rheumatoid arthritis drug Actemra for the treatment of pneumonia caused by COVID-19. The drug has already been approved for COVID-19 treatment in the U.S. and the European Union, and the final phase global clinical trial showed it significantly reduced the risk of death in hospitalized patients by helping prevent a cytokine storm, which is a life-threatening overreaction of the body’s immune system.