FDA Clears COVID Booster Shot for Healthy Children Ages 5 to 11

U.S. regulators on Tuesday approved a COVID-19 booster shot for healthy 5- to 11-year-olds, hoping that an additional vaccine dose will improve their protection as infections rise again.

Anyone 12 years and older would already receive one booster dose for the best protection against the latest coronavirus variants – and some people, including those 50 and older, may choose a second booster.

The Food and Drug Administration authorization now also opens up a third chance for elementary school-age children — at least five months after their last dose.

There’s another hurdle: The Centers for Disease Control and Prevention must decide whether to formally recommend the booster for this age group. The CDC’s scientific advisors will meet on Thursday.

Pfizer’s injection is the only COVID-19 vaccine available to children of any age in the US. Those ages 5 to 11 get one-third of the dose given to anyone ages 12 and older.

Whether elementary school-age kids need a booster is overshadowed by parental outcry to vaccinate even younger toddlers, kids under the age of 5 — the only group not yet eligible in the US. Both Pfizer and rival Moderna have studied their injections in the youngest children, and the FDA is expected to review data from one or both companies sometime next month.

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For the 5 to 11 year olds, it is not clear how much demand there will be for boosters. Only about 30% of that age group have had the first two doses of Pfizer since vaccinations opened for them in November.

But in a small study, Pfizer found a booster that increased those kids’ levels of virus-fighting antibodies — including those able to fight omicron — the same kind of jump adults get from an extra shot.

While the coronavirus is more dangerous to adults than children, young people can become seriously ill — and more than 350 children aged 5 to 11 have died, according to the CDC’s tally.

Adding to the public confusion, the CDC estimates that 3 in 4 American children of all ages have been infected with the coronavirus since the start of the pandemic — many of them during the winter microwave wave. Still, health authorities are pushing for vaccination, even in people who have previously had COVID-19, to bolster their protection.

Vaccination may not always prevent milder infections, especially since omicron and its siblings are better than some previous variants at slipping past those defense mechanisms. But health authorities agree that the vaccines continue to provide strong protection against the worst effects of COVID-19, including hospitalization and death.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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