An influential advisory panel voted Tuesday that all children ages 5 to 11 should get Pfizer’s pediatric COVID-19 shots, putting the U.S. on the brink of a major expansion of vaccinations — and a final decision is expected within hours.
The Food and Drug Administration already has OK’d kid-size doses — just a third of the amount given to teens and adults — as safe and effective for the younger age group.
The Centers for Disease Control and Prevention formally recommends who should receive FDA-cleared vaccines, and its advisers decided Pfizer’s shots should be opened to all 28 million children ages 5 to 11.
If the CDC’s director, Dr. Rochelle Walensky, signs off, it will mark the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine.
Shots into little arms could begin this week, as Pfizer already is packing and shipping the first orders, millions of doses, to states and pharmacies to be ready.
THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.
Should all school-age kids get Pfizer’s pediatric COVID-19 vaccine? That’s the question before an influential government advisory panel Tuesday.
The Food and Drug Administration has authorized emergency use of kid-size doses for children ages 5 to 11. But the Centers for Disease Control and Prevention also must sign off before widespread vaccinations begin in that age group.
CDC’s advisers are weighing who will get the most benefit as they deliberate whether to recommend the shots for up to 28 million more children, or perhaps only for those most vulnerable to serious illness. Their recommendation goes to the CDC’s director, Dr. Rochelle Walensky, for the final say.
“Today is a monumental day in the course of this pandemic,” Walensky told the advisory panel Tuesday.
She said while the risk of severe disease and death is lower in young children than adults, it is real — and that COVID-19 has had a profound social, mental health and educational impact on youngsters, including widening disparities in learning.
“There are children in the second grade who have never experienced a normal school year,” Walensky said. “Pediatric vaccination has the power to help us change all of that.”
Shots into little arms could begin this week, as Pfizer already is packing and shipping the first orders, millions of doses, to states and pharmacies to be ready.
Doctors who’ve cared for hospitalized youngsters hope parents embrace Pfizer’s kid shots, saying they’re safe and far better than gambling that a child will escape a coronavirus infection.
“I’ve seen plenty of children in this age group that have been seriously ill,” said Dr. Matthew Linam, an infectious disease specialist at Children’s Healthcare of Atlanta. “The risk of significant infection is still very real in this population.”
There have been more than 8,300 hospitalizations of kids ages 5 to 11, about a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group.
And while the U.S. has seen a recent downturn in COVID-19 cases, experts are worried about another uptick with holiday travel and as winter sends more activity indoors where it’s easier for the coronavirus to spread.
Pfizer’s kid shots contain a third of the vaccine dose that’s already been used to vaccinate millions of people 12 and older. The 5- to 11-year-olds will receive two shots, three weeks apart, the same schedule as everyone else -- but a smaller amount in each shot, using a smaller needle.
A study of 2,268 youngsters found the kid-size vaccine is nearly 91% effective at preventing symptomatic COVID-19 -- based on 16 diagnoses among kids given dummy shots compared to just three who got the real vaccination.
The FDA examined more children, a total of 3,100 who were vaccinated, in concluding the shots are safe. The younger children experienced similar or fewer reactions -- such as sore arms, fever or achiness -- than teens or young adults get after larger doses.
That study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. The FDA ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that rare risk.
The FDA’s decision came after its own advisers struggled with whether every young child needed a vaccine -- a key question in Tuesday’s deliberations, too. Youngsters hospitalized with COVID-19 are more likely to have high-risk conditions such as obesity or diabetes -- but otherwise healthy children can get seriously ill, too.
And many pediatricians and parents have clamored for protection for youngsters so they can resume normal childhood activities without risking their own health -- or the fear of bringing the virus home to a more vulnerable family member.
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