Moderna Says COVID Vaccine Is Safe for Babies, Toddlers

Company to seek authorization for low doses for kids under 6
By Newser Editors and Wire Services
Posted Mar 23, 2022 8:47 AM CDT
Moderna Says COVID Vaccine Is Safe for Babies, Toddlers
A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic at the Norristown Public Health Center in Norristown, Pa., on Dec. 7, 2021.   (AP Photo/Matt Rourke, File)

(Newser) – 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, per the AP. Moderna said in the coming weeks it would ask regulators in the US and Europe to authorize two 25-microgram doses for youngsters under 6. The company also is seeking approval of two 100-microgram shots (the original adult dose) for 12- to 17-year-olds and two 50-microgram shots for 6- to 11-year-olds. The nation's 18 million children under 5 are the only age group not yet eligible for vaccination. Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older.

But parents have anxiously awaited protection for younger tots, 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. Moderna said a quarter of the dose it uses for adults worked well for youngsters under age 6. Moderna enrolled about 6,900 tots in a study of the 25-microgram doses. Early data showed after two shots, youngsters developed virus-fighting antibody levels just as strong as young adults getting regular-strength shots, the company said. Moderna said the small doses were safe, and the main side effects were mild fevers.

COVID-19 vaccines in general don't prevent infection with the omicron mutant 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, conducted during the omicron surge. While there were no severe illnesses, the vaccine proved just under 44% effective at preventing any infection in babies up to age 2, and nearly 38% effective in the preschoolers. Once Moderna submits the data to the FDA, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them. (Read more coronavirus vaccine stories.)

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