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Moderna says its low-dose COVID shot works for kids 6-11

Vaccine maker says it will soon share interim results of study with FDA and global regulators

A Chester County, Pennsylvania, Health Department worker fills a syringe with Moderna COVID-19 vaccine, before administering it at the Chester County Government Services Center in West Chester, Pennsylvania, on December 29, 2020. (AP Photo/ Matt Slocum, File)
A Chester County, Pennsylvania, Health Department worker fills a syringe with Moderna COVID-19 vaccine, before administering it at the Chester County Government Services Center in West Chester, Pennsylvania, on December 29, 2020. (AP Photo/ Matt Slocum, File)

AP — Moderna said Monday that a low dose of its COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds, as the manufacturer joins its rival Pfizer in moving toward expanding shots to children.

Pfizer’s kid-size vaccine doses are closer to widespread use. They are undergoing evaluation by the US Food and Drug Administration for youngsters in nearly the same age group, 5 to 11, and could be available by early November. The company’s vaccine is already authorized for those who are 12 or older.

Moderna has not yet gotten the go-ahead to offer its vaccine to teens, but is studying lower doses in younger children while it waits.

Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults. Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, Moderna said in a news release.

The study involved 4,753 children ages 6 to 11 who got either the vaccine or dummy shots. Moderna said that, like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever, and injection site pain.

The study was too small to spot any extremely rare side effects, such as heart inflammation that occurs infrequently after either the Moderna or Pfizer vaccines, mostly among young men.

Vials of the Moderna COVID-19 vaccine are seen at the Assad Iben El Fourat school in Oued Ellil, outside Tunisa, August 15, 2021. (AP Photo/Hassene Dridi, File)

Moderna released no further details and has not submitted its data to a scientific journal, but said it plans to share the interim results with the FDA and global regulators soon. The study is still going on, and the company cannot calculate the vaccine’s effectiveness in actually preventing infections in children unless there are sufficient COVID-19 cases to compare rates between vaccinated and unvaccinated participants.

The FDA has not yet ruled on the company’s application to expand its vaccinations to 12- to 17-year-olds, although some countries have cleared Moderna’s shots for adolescents.

But the US is expected to begin vaccinating children under 12 sometime next month, if the FDA clears low doses of the Pfizer vaccine for 5- to 11-year-olds. Pfizer reported last week that its kid-size doses proved nearly 91% effective at preventing symptomatic COVID-19 in that age group, even as the extra-contagious Delta variant was spreading widely.

FDA’s advisers will weigh Pfizer’s evidence in a public meeting Tuesday. If the agency authorizes Pfizer’s kid shots, the Centers for Disease Control and Prevention the following week is set to recommend who should receive them.

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