Moderna's COVID-19 vaccine works in babies, toddlers and preschoolers, the company announced Wednesday — and if regulators agree it could mean a chance to finally start vaccinating the littlest kids by summer.
Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under six. 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 tots 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 super-contagious Omicron mutant than prior variants.
"The vaccine provides the same level of protection against COVID in young kids as it does in adults. We think that's good news," Dr. Stephen Hoge, Moderna's president, told The Associated Press.
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 young adults who get full-strength shots, the company said.
Moderna's study in tots was conducted during the Omicron surge and found the same trend: While there were no severe illnesses, the vaccine proved just under 44% effective at preventing milder infections in babies up to age 2, and nearly 38% effective in the preschoolers.
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The COVID vaccine proved nearly 38% effective in preventing milder infections in preschoolers.
(Photo: AFP)
But Hoge said high antibody levels still should translate into protection against severe disease in young kids just like they do in adults, "which ultimately is probably the strongest reason for somebody to get vaccinated."
Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.
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-age kids, it's using half the adult dose.