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Moderna says its low-dose COVID-19 shot works for children under 6

Health worker administering an injection
A health worker administers a dose of Moderna’s COVID-19 vaccine at a clinic in Norristown, Pa.
(Matt Rourke / Associated Press)
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Moderna’s COVID-19 vaccine works in babies, toddlers and preschoolers, the company said Wednesday — and if regulators agree, it could mean a chance to start vaccinating the nation’s youngest children by summer.

Moderna said that in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for children under 6. The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.

Early results from the study found that very young children developed high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults — although it was less effective against the more contagious Omicron variant than against prior strains.

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“The vaccine provides the same level of protection against COVID in young kids as it does in adults. We think that’s good news,” Stephen Hoge, Moderna’s president, told the Associated Press.

The 18 million children under 5 in the U.S. are the only age group not yet eligible for COVID-19 vaccination. Drugmaker Pfizer currently offers kid-sized doses for elementary-school-age children and full-strength shots for those 12 and older.

But parents have anxiously awaited protection for younger children, and have been disappointed by setbacks and confusion over which shots might work and when. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn’t prove strong enough. Those results are expected by early April.

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Vaccinating the nation’s youngest residents “has been somewhat of a moving target over the last couple of months,” Dr. Bill Muller of Northwestern University, an investigator in Moderna’s pediatric studies, said in an interview before the company released its findings. “There’s still, I think, a lingering urgency to try to get that done as soon as possible.”

The younger the child, the smaller the dose being tested. Moderna enrolled about 6,900 kids under 6 — including babies as young as 6 months — in a study of the 25-microgram doses. They developed levels of antibodies just as strong as those in young adults who get full-strength shots, the company said.

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Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.

Once Moderna submits the data to the Food and Drug Administration, regulators will debate whether to authorize emergency use of the small doses. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.

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While COVID-19 generally isn’t as dangerous to small children as to adults, some do become severely ill. The CDC says about 400 children younger than 5 have died from the disease since the pandemic’s start. The Omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous Delta surge, the CDC found.

COVID-19 vaccines in general don’t prevent infection with the Omicron strain as well as they fended off earlier variants. But they do still offer strong protection against severe illness.

Moderna reported that same trend in the trial of children under 6, which was conducted during the Omicron surge. While there were no severe illnesses, the vaccine proved just under 44% effective at preventing infection in babies up to age 2, and nearly 38% effective in the preschoolers.

But Hoge said high antibody levels still should translate into protection against severe disease in young kids, just as they do in adults, “which ultimately is probably the strongest reason for somebody to get vaccinated.”

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Moderna also said Wednesday that it would ask the FDA to clear larger doses for older children.

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While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months.

The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too.

Moderna says its original adult dose — two 100-microgram shots — is safe and effective in 12- to 17-year-olds. For elementary-school-age kids, it’s using half the adult dose.

But the FDA never ruled on Moderna’s application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after they receive either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots contain a far higher dosage than Pfizer’s.

The risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to children as young as 6.

“That concern has not been seen in the younger children,” said Northwestern’s Muller.

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