A health ministry panel on Monday backed Moderna Inc.’s COVID-19 vaccine for emergency use in around 4 million children age 12 to 17, paving the way for final approval by the ministry in the coming days.
The panel recommended lowering the current age restriction of 18 and older without conducting an additional clinical trial in the country. Pfizer Inc.’s vaccine has already been authorized for emergency use in children 12 and older since June 1.
Moderna last month asked regulators in Japan, the U.S. and other nations to lower the minimum age for the vaccine from 18 to 12 after Moderna’s late stage clinical trial involving 3,732 adolescents showed in May that the jab was 100% effective starting 14 days after the second dose and “well tolerated” with no significant safety concerns identified.
The European Union drug regulator is also expected to recommend that the shot be used in children as young as 12 this week, but the U.S. Food and Drug Administration has not lowered the age limit from 18 yet.
The approval would mark a step forward in Japan’s fight against the coronavirus, as this would give adolescents two options for vaccination, said Dr. Hiroyuki Moriuchi, professor of pediatrics at Nagasaki University.
“By making it possible to use both the vaccines made by Pfizer and Moderna, it will become easier to vaccinate children with existing chronic diseases, which is a good thing,” he said.
But Moriuchi said healthy children should not rush to get the vaccine just yet. Aside from high-risk children who are more likely to have severe coronavirus symptoms, healthy children should be the very last in the order of the vaccination campaign, he explained, as it makes more sense to prioritize vaccinating older age groups given the vast number of infections in children were transmitted from adults.
He added that British data has shown that only two children have died of COVID-19 out of 1 million cases, and that no children have died yet in Japan, where the number of infections is much lower than that of the U.K.
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 a difficulty in adequately explaining the vaccines to parents and a tendency for children to face peer pressure over getting a shot. It’s important that each child and parent understand the risks and benefits, experts say.
The health ministry says that minors age 16 and older can receive the vaccine without parental consent, but that children age 15 and younger are required to have a parental signature to get a shot.
Pfizer’s vaccine was also found to be 100% effective in a final clinical trial of more than 2,200 adolescents. While Pfizer’s vaccine in general is said to cause slightly more cases of severe allergic reactions called anaphylaxis, people who get the Moderna shot tend to report more cases of minor side effects such as muscle pain, fever, fatigue or red, itchy rashlike reactions known as “Moderna arm,” Moriuchi said.
Currently, Pfizer and Moderna are looking to expand the use of their vaccines even further to babies and younger children under age 12. Both firms have administered their vaccines to thousands of volunteers as part of a global trial for children ages 6 months to 11 years old, and are reportedly planning to request the authorization for use in children ages 5 to 11 this year.
The health ministry on Monday also gave emergency-use authorization to a monoclonal antibody-based treatment developed by U.S. firm Regeneron Pharmaceuticals Inc. This is the fourth drug approved in Japan for treating COVID-19 and the first for the treatment of mild to moderate COVID-19 cases.
Chugai Pharmaceutical Co., which had applied for the authorization late last month, said this marks the world's first approval for Ronapreve, which in a global final stage clinical trial showed its ability to suppress symptoms and shorten the recovery time based on a single dose.
The health ministry said that a clinical trial involving COVID-19 patients with a high risk of developing serious symptoms, such as those with obesity or high blood pressure, showed that the drug reduced the risk of hospitalization or death by 70.4%.
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