Japanese Ministry of Health panel backs lowering Moderna’s age limit to 12

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A Department of Health panel on Monday supported Moderna Inc.’s COVID-19 vaccine for emergency use in approximately 4 million children aged 12 to 17, paving the way for final ministry approval in the next days.

The panel recommended lowering the current age limit of 18 and over without conducting additional clinical trials in the country. Pfizer Inc.’s vaccine has already been approved for emergency use in children 12 years of age and older as of June 1.

Last month, Moderna called on regulators in Japan, the United States and other countries to lower the minimum age for the vaccine to 12 from 18 after Moderna’s advanced clinical trial involving 3 732 adolescents showed in May that the vaccine was 100% effective from 14 days after the second. dose and “well tolerated” with no significant safety concerns identified.

The European Union’s drug regulator is also expected to recommend that the vaccine be used in children as young as 12 this week, but the U.S. Food and Drug Administration has yet to lower the limit to age 18.

The approval would mark a step forward in Japan’s fight against the coronavirus, as it would give teens two vaccination options, said Dr Hiroyuki Moriuchi, professor of pediatrics at Nagasaki University.

“By allowing the use of both the vaccines manufactured by Pfizer and Moderna, it will become easier to immunize children with existing chronic diseases, which is a good thing,” he said.

But Moriuchi said healthy children shouldn’t rush to get vaccinated just yet. With the exception of high-risk children who are more likely to have severe symptoms of coronavirus, healthy children should be very last in the order of the vaccination campaign, as it makes more sense to vaccinate from other age groups as a priority given the large number of infections. in children come from transmission from adults, he said.

He added that British data showed that only two children have died from COVID-19 in 1 million cases, and that no child has yet died in Japan, where the number of infections is much lower than that of UK.

A health worker prepares a dose of Pfizer-BioNTech COVID-19 vaccine to be administered to a minor in Santiago in June. | AFP-JIJI

The Japanese Pediatric Society said vaccinating healthy children is an important step, but added that it should be taken with caution. The ministries of education and health have sent a notice to municipalities that the government does not recommend mass vaccinations in schools, due to difficulty in properly explaining vaccines to parents and a trend of children to face peer pressure to get immunized. It’s important that every child and parent understands the risks and benefits, experts say.

The health ministry said minors 16 and over can receive the vaccine without parental consent, but children 15 and under must have a parental signature to be vaccinated.

Pfizer’s vaccine was also found to be 100% effective in a final clinical trial involving more than 2,200 adolescents. While Pfizer’s vaccine in general is believed to cause slightly more cases of serious allergic reactions called anaphylaxis, people who receive the Moderna vaccine tend to report more cases of minor side effects such as muscle pain, muscle pain, pain. fever, fatigue, or a red, itchy skin reaction called “Modern Arm,” Moriuchi said.

Currently, Pfizer and Moderna are looking to further expand the use of their vaccines to babies and toddlers under 12. The two companies administered their vaccines to thousands of volunteers in a global trial for children aged 6 months to 11 years. , and reportedly intend to seek authorization for use in children aged 5 to 11 this year.

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