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Pfizer's COVID-19 boosters for kids 5 and up get emergency use authorization from FDA

The decision now falls to the Centers for Disease Control and Prevention, which will recommend how to use the boosters for the 5-11 age group.

WASHINGTON — U.S. officials have authorized a booster of Pfizer's COVID-19 vaccine for children aged 5-11 under an emergency use authorization. 

The U.S Food and Drug Administration announced the update Tuesday, a win celebrated vaccine advocates seeking to protect the nation's youngest. The decision now falls to the Centers for Disease Control and Prevention on whether to formally recommend the vaccine for that age group.

The CDC’s scientific advisers are scheduled to meet on Thursday.

The booster shot is 10 micrograms, which is the same dosage given during the primary series of vaccines for that age group. Older patients receive larger doses when getting vaccinated. 

Children as young as five were allowed to get the Pfizer shots since last year, but were unable to get boosters, even as their use was expanded to most U.S. adults. 

Anybody 5 or older can now get a booster of the Pfizer vaccine five months after completion of their initial set of two shots. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf in a statement,  "Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”   

Everyone 12 and older already was supposed to get one booster dose for the best protection against the newest coronavirus variants -- and some people, including those 50 and older, can choose a second booster.

Comirnaty, the vaccine's official name, is authorized for full use in anybody 16 and up. Those under 16 are still able to take the vaccine, although it is under an emergency use authorization for the time being.

Whether elementary-age children need a booster has been overshadowed by parents’ outcry to vaccinate even younger tots, those under 5 -- the only group not yet eligible in the U.S. Both Pfizer and rival Moderna have been studying their shots in the youngest children, and the FDA is expected to evaluate data from one or both companies sometime next month.

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

But in a small study, Pfizer found a booster revved up 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 to children, youngsters can get severely ill -- and more than 350 children ages 5 to 11 have died, according to CDC’s count.

Adding to public confusion, the CDC estimates 3 out of every 4 U.S. children of all ages have been infected with the coronavirus since the pandemic’s start -- many of them during the winter omicron wave. Still, health authorities urge vaccination even in people who’ve previously had COVID-19, to strengthen their protection.

Vaccination may not always prevent milder infections, especially as omicron and its siblings are better than some prior variants at slipping past those defenses. But health authorities agree the vaccinations continue to offer strong protection against the worst outcomes of COVID-19, including hospitalization and death.

Protection against COVID in all age groups appears to wane several months after getting an initial vaccine set, dropping from somewhere in the 90% effective range to somewhere in the 60% range. 

The news comes a day after the U.S. reached a grim milestone: 1 million dead from COVID-19. While the majority of the deaths were in older or immunocompromised Americans and children generally appear to have fewer serious symptoms, health experts have long warned of "long COVID" and the long-term effects of the virus on those who survive, including those who only get mildly sick.

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