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U.S. health officials on Tuesday gave the final signoff to Pfizer's kid-size COVID-19 shot, a major expansion of the nation's vaccination campaign.
The Food and Drug Administration already authorized the shots for children ages 5 to 11 - doses just a third of the amount given to teens and adults. But the U.S. Centers for Disease Control and Prevention recommends who should receive FDA-cleared vaccines.
The announcement by CDC director Dr. Rochelle Walensky came only hours after an advisory panel unanimously decided Pfizer's shots should be opened to the 28 million youngsters in that age group.
"Today is a monumental day in the course of this pandemic," Walensky told the advisory panel as it began its deliberations earlier 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."
Millions of shots made by Pfizer and its partner BioNTech have already been shipped to states, doctors' offices and pharmacies - in orange caps, to avoid mix-ups with purple-capped vials of adult vaccine.
The American Academy of Pediatrics welcomed the news. The 5- to 11-year-olds will receive two shots, three weeks apart, the same schedule as everyone else - but using a smaller needle.
Many parents have clamored for vaccine protection for youngsters so they can resume normal childhood activities without risking their own health - or fear bringing the virus home to a more vulnerable family member. But CDC's advisers said they recognize many parents also have questions and may be fearful of the vaccine because of rampant misinformation.
The panelists said they want parents to ask their pediatrician about the shots - and to understand that they're far better than gambling that their child will escape a serious coronavirus infection. As for safety, more than 106 million Americans have safely gotten two doses of Pfizer's full-strength shots - including more than 7 million 12- to 15-year-olds.
"I have vaccinated my kids," said CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University, saying she wouldn't recommend something for other families unless she was comfortable with it for her own. "We have seen the devastation of this disease."
In the U.S., 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, with additional reports under investigation.
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 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. Regulators ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that rare risk.
"The risk of some sort of bad heart involvement is much higher if you get COVID than if you get this vaccine," Dr. Matthew Oster, a pediatric cardiologist at Emory University, told the panel. "COVID is much riskier to the heart."
Last week, FDA's advisers struggled with whether every young child needed a vaccine. 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 the CDC's advisers ultimately recommended the shots for all of them - even children who've already recovered from a bout of COVID-19.
CDC officials calculated that for every 500,000 youngsters vaccinated, between 18,000 and 58,000 COVID-19 cases - and between 80 and 226 hospitalizations - in that age group would be prevented, depending on the pandemic's trajectory. And CDC officials noted that COVID-19 has caused more deaths in this age group than some other diseases, such as chickenpox, did before children were routinely vaccinated against them.