FDA approves COVID booster injection for healthy children ages 5 to 11 as infections creep up again

US regulators on Tuesday approved a COVID-19 booster injection for healthy 5- to 11-year-olds, with the hope that an additional vaccine dose will improve their protection if infections resurface.

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, can choose a second booster

Food and Drug Administration approval now also opens a third injection of Pfizer’s vaccine 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 and its partner BioNTech are making the only COVID-19 vaccine available to children of all ages in the US. Those ages 5 to 11 get one-third of the dose given to anyone ages 12 and older.

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.

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 Pfizer’s vaccine “is effective in helping to prevent the most severe effects of COVID-19 in individuals ages 5 and older,” said FDA vaccine chief Dr. Peter Marks, who added that “a booster dose may help provide lasting protection against COVID-19 in these and older age groups.”

In a small study, Pfizer found a booster that increased those kids’ levels of virus-fighting antibodies — including those capable of fighting the super-infectious Omicron variant — the same kind of jump that 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 wintery Omicron wave. Still, health authorities are pushing for vaccination, even in people who have previously had COVID-19, to bolster their protection.

With Omicron subtypes now proliferating, an average of about 91,000 cases are reported per day in the US, compared to about 57,000 just two weeks ago. That’s a small fraction of the infections seen during the brutal winter wave — but experts also say it’s a huge undercount, as the number of tests has dwindled and home tests often go unreported.

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.

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