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Pfizer asks FDA to authorize COVID booster for kids 5 to 11 years old

Earlier this month, Pfizer released new data and said healthy 5-to-11-year-olds could benefit from another kid-sized shot.

WASHINGTON — Pfizer on Tuesday said it has asked the Food and Drug Administration to authorize a booster dose of its COVID vaccine for children from 5 to 11 years old. 

U.S. health authorities already urge everyone 12 and older to get one booster dose for the best protection against the newest variants -- and recently gave the option of a second booster to those 50 and older.

Pfizer first announced its intention to apply for emergency use authorization earlier in April, releasing new data it said showed 5-to-11-year-olds could benefit from another kid-size shot.

In the small study, 140 youngsters who’d already gotten two shots were given a booster six months later, and researchers found the extra shot generally revved up their immune response. But a closer look at 30 of the children found a 36-fold increase in virus-fighting antibodies, levels high enough to fight the super-contagious omicron variant, Pfizer and its partner BioNTech said in a mid-April press release. 

Pfizer tested the kid booster while omicron was surging this winter. While COVID-19 cases now are at much lower levels in the U.S., in recent weeks an even more contagious version of omicron, called BA.2, has become the dominant type locally and around the world.

Vaccinations are generally less effective against the omicron variant than earlier versions of the coronavirus -- but they do still offer strong protection against severe disease. While COVID-19 is a bigger threat to adults, children can get seriously ill. But regulators will have to decide if healthy elementary-age kids really need a booster, and if so, when.

The Pfizer shots are the only vaccine available to U.S. children. Those ages 5 to 11 receive one-third of the dose given to everyone 12 and older. Just over a quarter in the younger age group have gotten two doses since vaccination opened to them in November, shortly before omicron struck.

The U.S. hasn’t yet allowed vaccinations for children under 5. But certain 5- to 11-year-olds -- those with severely weakened immune systems -- already are supposed to get three doses, to give that high-risk group a better chance of responding.

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