U.S. health officials on Tuesday gave final approval to Pfizer’s child-sized COVID-19 injection, a milestone that opens a major expansion of the country’s vaccination campaign for children as young as 5 years old.
The Food and Drug Administration has already authorized the injections for children ages 5 to 11 — doses just one-third the amount given to teens and adults. But the Centers for Disease Control and Prevention formally recommends who should get FDA-approved vaccines.
The announcement by CDC director Dr. Rochelle Walensky came just hours after an advisory panel unanimously decided that Pfizer’s injections should be opened up to the 28 million young people in that age group.
The decision marks the first chance for Americans under the age of 12 to receive the powerful protection of a COVID-19 vaccine.
“As a mother, I encourage parents with questions to speak with their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of vaccinating their children,” Walensky said in a statement Tuesday evening.
In comments earlier in the day, she said that while the risk of serious illness 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 young people, including broadening differences in learning.
“There are kids in the second grade who have never experienced a normal school year,” Walensky said. “Childhood vaccination has the power to help us change all that.”
President Joe Biden called the decision “a turning point.”
“It will enable parents to end months of anxious worrying about their children, and reduce the extent to which children spread the virus to others,” he said in a statement. “It is a big step forward for our nation in our fight to beat the virus.”
The American Academy of Pediatrics welcomed the decision as its members get ready to start the first small arms injections, 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 with a smaller needle.
Pfizer began shipping millions of the pediatric injections to states, doctors’ offices and pharmacies over the weekend — in orange caps, to avoid mixing up purple cap vials of adult vaccine.
Many parents have pushed for vaccine protection for young people so they can resume normal childhood activities without endangering their own health — or fearing bringing the virus home to a more vulnerable family member. But CDC’s advisers said they recognize that many parents also have questions and may fear the vaccine because of rampant misinformation.
Members of the advisory panel said they want parents to ask about the injections – and understand that they are far better than gambling that their child will escape a serious coronavirus infection. On the safety side, more than 106 million Americans have safely received two doses of Pfizer’s high-potency injections — including more than 7 million 12- to 15-year-olds.
“I vaccinated my children,” said CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University, who said she wouldn’t recommend anything to other families unless she felt comfortable doing it herself. “We’ve seen the devastation of this disease.”
In the US, according to government data, there have been more than 8,300 coronavirus-related hospitalizations of children aged 5 to 11, about a third of whom require intensive care. The CDC has recorded at least 94 deaths in that age group, with additional reports under investigation.
And while the US has seen a recent decline in COVID-19 cases, experts are concerned about another uptick in leisure travel and as winter sends more activity indoors where the coronavirus can spread more easily.
Pfizer’s study of 2,268 youth found that the childhood vaccine is nearly 91% effective in preventing symptomatic COVID-19 — based on 16 diagnoses in children who received dummy injections compared to just three who received the real vaccine.
The FDA examined more children, a total of 3,100 who had been vaccinated, and concluded that the shots are safe. The younger children experienced similar or fewer reactions — such as aching arms, fever, or pain — than teens or young adults after larger doses.
That study was not large enough to detect extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full dose, usually in young men and teenage boys. Regulators ultimately decided that the benefits of vaccination outweigh the potential that younger children given a smaller dose may also face that rare risk.
Some CDC advisers said for some parents that the decision to have their children vaccinated may depend on that small but scary risk.
“The risk of some form of heart involvement is much higher if you get COVID than if you get this vaccine,” Dr. Matthew Oster, a pediatric cardiologist at Emory University, to the panel. “COVID is much more risky for the heart.”
Last week, FDA advisors grappled with whether every young child needed a vaccine. Young people hospitalized with COVID-19 are more likely to develop high-risk conditions such as obesity or diabetes. But otherwise healthy children can also become seriously ill, and CDC advisers eventually recommended the injections for all of them — even children who have already recovered from a bout of COVID-19.
CDC officials calculated that for every 500,000 young people vaccinated, between 18,000 and 58,000 cases of COVID-19 — and between 80 and 226 hospitalizations — in that age group would be prevented, depending on the trajectory of the pandemic. And CDC officials noted that COVID-19 caused more deaths in this age group than some other diseases, such as chickenpox, before children were routinely vaccinated against them.
What about younger children? Pfizer is testing infant and toddler recordings and expects data around the end of the year. The similarly made Moderna vaccine is also being studied in young children. But the FDA still hasn’t approved its use in teens, and the company is deferring the application to younger children pending that review.
A few countries have started using other COVID-19 vaccines in children under 12, including China, which has just started vaccinations for 3-year-olds. But many who use the Pfizer-BioNTech vaccine are looking at the US decision, and European regulators have just started considering the companies’ pediatric doses.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.