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US gives final approval to COVID-19 shots for children ages 5 to 11

US health officials on Tuesday gave the final nod to Pfizer’s child-sized COVID-19 shot, a milestone that opens a major expansion of the country’s vaccination campaign to children under the age of 5.

The Food and Drug Administration has already authorized the shots for children ages 5 to 11 — just a third of the amount given to teens and adults. But the Centers for Disease Control and Prevention do formally recommend who should receive FDA-approved vaccines.

CDC Director Dr. Rochelle Valensky’s announcement came just hours after an advisory panel unanimously decided that Pfizer’s shots should be opened to 28 million youth in that age group.

The decision marks the first time for Americans under the age of 12 to receive the potent protection of any COVID-19 vaccine.

Valensky said in a statement Tuesday night, “As a mom, I encourage parents to talk to their pediatrician, school nurse or local pharmacist to learn about vaccines and the importance of vaccinating their children.” to know more about.”

In remarks earlier in the day, she said the lower risk of serious illness and death among young children than adults is real – and that COVID-19 has had profound social, mental health and educational impacts on youth, including Including being comprehensive. learning inequality.

“There are kids in second grade who have never experienced a normal school year,” Valensky said. “Pediatric vaccination has the power to help us change all of that.”

President Joe Biden called the decision “a turning point.”

“This will allow parents to end months of worrying about their children and reduce the extent to which children can spread the virus to others,” he said in a statement. “This is a big step forward for our country in our fight to defeat the virus.”

The American Academy of Pediatrics welcomed the decision as its members prepared to begin the first injections into small arms, which the CDC said could begin “as soon as possible.” Children ages 5 to 11 will receive two low doses of the vaccine, made by Pfizer and its partner BioNTech, three weeks apart — the same as everyone else, but using a smaller needle.

Pfizer over the weekend began shipping millions of pediatric shots to states, doctors’ offices and pharmacies — in orange caps, to avoid mixing with purple-capped vials of the adult vaccine.

Many parents have fought for vaccine protection for young people so they can resume normal childhood activities without risking their own health – or bringing the virus home to a more vulnerable family member. afraid. But CDC advisers said they recognize that many parents have questions, too, and may fear vaccines because of widespread misinformation.

Members of the advisory panel said they want parents to ask about the shots – and understand they are far better than gambling their child will avoid a serious coronavirus infection. As for safety, more than 106 million Americans have safely received two doses of Pfizer’s full-strength shots — including more than 7 million 12- to 15-year-olds.

“I have vaccinated my kids,” said Dr. Helen Kiep Talbot, a CDC consultant at Vanderbilt University who said she wouldn’t recommend something to other families until she was comfortable with it for herself. I’ve seen devastation.”

In the US, there have been more than 8,300 coronavirus-related hospitalizations of children aged 5 to 11, with nearly a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group, with additional reports being investigated.

And while the US has seen a decline in COVID-19 cases recently, experts are concerned about another uptick with holiday travel and as winter sends more activity indoors where the spread of the coronavirus is easing.

Pfizer’s study of 2,268 youth found that the child-sized vaccine was about 91% effective in preventing symptomatic COVID-19 — 16 among children given dummy shots compared to only three who received the actual vaccination. Diagnosis is based.

The FDA examined more children, a total of 3,100 who were vaccinated, concluding that the shots are safe. Younger children experienced the same or fewer reactions — such as sore throat, fever or pain — than teens or young adults get after the larger dose.

This study was not large enough to detect any extremely rare side effects, such as heart swelling that sometimes occurs after a second full-strength dose, mostly in young men and adolescent boys. Regulators eventually judged the benefits of vaccination were that young children could experience that rare risk even when they received a small dose.

For some parents, the decision to vaccinate their children may hinge on that small but scary risk, some CDC advisers said.

“If you get this vaccine, you have a very high risk of developing some kind of heart failure,” Dr. Matthew Oster, a pediatric cardiologist at Emory University, told the panel. “Covid is 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 have a high-risk condition such as obesity or diabetes. But otherwise healthy children can also become seriously ill, and CDC advisers eventually recommended shots for everyone — even children who have already recovered from a bout of COVID-19. Huh.

CDC officials calculated that for every 500,000 youth vaccinated, between 18,000 and 58,000 COVID-19 cases — and between 80 and 226 hospitalizations — would be prevented, depending on the trajectory of the pandemic in that age group. 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 small children? Pfizer is testing shots for infants and preschoolers and expects to have data by the end of the year. Similarly, the modern vaccine made is also being studied on young children. But the FDA still hasn’t approved its use in teens, and the company is delaying its application for young children pending that review.

Some countries have started using other COVID-19 vaccines in children under the age of 12, including China, which has just started vaccination for 3-year-olds. But many who use the Pfizer-BioNTech vaccine are looking at the US decision, and European regulators have begun to consider the companies child-sized doses.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. NWN is solely responsible for all content.

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