U.S. health officials gave the final signoff to Pfizer’s kid-size COVID-19 shot, a milestone that opens a significant expansion of the nation’s vaccination campaign to children as young as 5.
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 Centers for Disease Control and Prevention formally 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.
The decision marks the first opportunity for Americans under 12 to get the protection of any COVID-19 vaccine.
The American Academy of Pediatrics welcomed the decision as its members get ready to start the first injections into little arms, which the CDC said could begin “as soon as possible.” The 5- to 11-year-olds will receive two low doses, three weeks apart, of the vaccine made by Pfizer and its partner BioNTech — 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.
Members of the advisory panel said they want parents to ask about the shots — and 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.
According to government data, in the U.S., there have been more than 8,300 coronavirus-related hospitalizations of kids ages 5 to 11, about a third requiring intensive care. 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 vaccinated, 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.
What about younger children? Pfizer is testing shots for babies and preschoolers and expects data around the end of the year. The similarly made Moderna vaccine also is being studied with young children. But the FDA still hasn’t cleared its use in teens, and the company is delaying its application for younger children pending that review.
A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just started vaccinations for 3-year-olds. But many that use the Pfizer-BioNTech vaccine are watching the U.S. decision, and European regulators just began considering the companies’ kid-size doses. Continue reading.
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