cloudyn.png
Friday January 21st, 2022 9:25PM

US gives final clearance to COVID-19 shots for kids 5 to 11

By The Associated Press

U.S. health officials on Tuesday gave the final signoff to Pfizer’s kid-size COVID-19 shot, a milestone that opens a major 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 powerful protection of any COVID-19 vaccine.

“As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Walensky said Tuesday night, in a statement.

In remarks earlier in the day, 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.”

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

“It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others," he said in a statement. “It is a major step forward for our nation in our fight to defeat the virus.”

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.

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

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.

“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 coronavirus-related 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.

Some of CDC's advisers said for some parents, deciding to get their children vaccinated may hinge on that small but scary 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.

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 began 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.

___

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

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP Health - Children's Health, AP Business, AP Business - Industries, AP Business - Health Care
© Copyright 2022 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
US gives final clearance to COVID-19 shots for kids 5 to 11
US health officials have given the final OK to Pfizer's COVID-19 vaccine for children as young as 5
7:47PM ( 10 minutes ago )
Starkly different portrayals of Rittenhouse in Kenosha trial
A prosecutor says Kyle Rittenhouse instigated the confrontation that led him to shoot three people on the streets of Kenosha, Wisconsin, during a turbulent protest against racial injustice
7:46PM ( 11 minutes ago )
Raiders WR Ruggs facing felony charges in fatal Vegas crash
Las Vegas police and his attorney say Raiders wide receiver Henry Ruggs III was released from a hospital and taken to jail ahead of an initial court appearance Wednesday on multiple felony charges after a fiery predawn vehicle crash that left a woman dead and Ruggs and his female passenger injured
7:44PM ( 12 minutes ago )
Associated Press (AP)
New Ronald Greene autopsy dumps crash theory in fatal arrest
A reexamined autopsy ordered by the FBI in the deadly 2019 arrest of Ronald Greene has rejected the Louisiana State Police claim that a car crash caused his fatal injuries
7:04PM ( 53 minutes ago )
Instigator or victim? Rittenhouse on trial in Kenosha
A prosecutor says Kyle Rittenhouse instigated the confrontation that led him to shoot three people on the streets of Kenosha, Wisconsin, during a turbulent protest against racial injustice
7:02PM ( 56 minutes ago )
EXPLAINER: Why Arbery slaying video will be 'star witness'
It's hard to overstate the importance that the video of Ahmaud Arbery's slaying will during the trial of the men who chased and shot him
7:01PM ( 57 minutes ago )
AP National News
Leaders vow to protect forests, plug methane leaks at COP26
World leaders are promising to protect Earth's forests, cut methane emissions and help South Africa wean itself off coal at the U.N. climate summit
5:02PM ( 2 hours ago )
AP VoteCast: Economy, COVID, schools top issues in Virginia
The economy ranked as the top issue facing the state of Virginia as voters cast their ballots in the tight race for governor, with the coronavirus pandemic and education trailing
5:01PM ( 2 hours ago )
Minneapolis voters weigh fate of police after George Floyd
Voters in Minneapolis are deciding whether to replace the city’s police department with a new Department of Public Safety
4:51PM ( 3 hours ago )
Top General short headlines
US advisers urge COVID shot for kids 5-11, final OK due soon
An influential U.S. advisory panel is recommending that all children ages 5 to 11 should get Pfizer’s pediatric COVID-19 vaccine
5:05PM ( 2 hours ago )
Democrats reach drug price deal, Biden upbeat on Manchin
Democrats announced they have sealed a deal to lower pharmaceutical drug costs for seniors as part of President Joe Biden’s sweeping $1.75 trillion domestic proposal
4:45PM ( 3 hours ago )
Brazil weekly COVID-19 death toll at lowest since April 2020
Brazil’s seven-day total for deaths from COVID-19 has fallen to its lowest level since the start of the pandemic
3:54PM ( 4 hours ago )
AP Health
Pfizer tops Q3 forecasts as total COVID vaccine sales soar
Pfizer beat third-quarter expectations and raised its 2021 forecast again even as sales of its top product, the COVID-19 vaccine Comirnaty, slipped in the U.S. Soaring international sales of the preventive shots helped pushed total Comirnaty revenue close to $13 billion in the quarter, and the drugmaker said Tuesday that it now expects to book about $36 billion in sales from the vaccine this year
8:42AM ( 11 hours ago )
COVID vaccine for younger kids already being packed, shipped
The White House says the Biden administration is already assembling and shipping millions of doses of the COVID-19 vaccine for children ages 5-11
4:43PM ( 1 day ago )
FDA paves way for Pfizer COVID-19 vaccinations in young kids
The Food and Drug Administration has paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine
5:23PM ( 4 days ago )
AP Health - Children's Health
Democratic chair issues subpoenas to oil executives
The chairwoman of the House Oversight Committee has issued subpoenas to top executives of ExxonMobil, Chevron and other oil giants, charging that the companies have not turned over documents needed by the committee to investigate allegations that the oil industry concealed evidence about the dangers of global warming
6:50PM ( 1 hour ago )
Avis' stock soars on earnings blowout, burning short sellers
Shares of Avis doubled after the rental car company’s third-quarter results showed it is well on the road to recovery from damage inflicted by the pandemic on the global travel industry
6:41PM ( 1 hour ago )
The Latest: UK sets net-zero plan for its financial sector
The British government plans to make the U.K. “the world’s first net-zero aligned financial center” as companies and investors seek to profit from the drive to build a low-carbon economy
6:34PM ( 1 hour ago )
AP Business
Starkly different portrayals of Rittenhouse in Kenosha trial
A prosecutor says Kyle Rittenhouse instigated the confrontation that led him to shoot three people on the streets of Kenosha, Wisconsin, during a turbulent protest against racial injustice
7:46PM ( 16 minutes ago )
Raiders WR Ruggs facing felony charges in fatal Vegas crash
Las Vegas police and his attorney say Raiders wide receiver Henry Ruggs III was released from a hospital and taken to jail ahead of an initial court appearance Wednesday on multiple felony charges after a fiery predawn vehicle crash that left a woman dead and Ruggs and his female passenger injured
7:44PM ( 18 minutes ago )
Polls close in tight Virginia governor race, count underway
The polls have closed and votes are being counted in Virginia's tight governor's race, which is also the first major test of how voters feel about Joe Biden’s presidency
7:44PM ( 18 minutes ago )
Bayern, Juventus through to Champions League knockout rounds
Robert Lewandowski has scored a hat trick on his 100th Champions League appearance to lead Bayern Munich into the last-16 with a 5-2 rout of Benfica
7:34PM ( 28 minutes ago )
AP VoteCast: Youngkin viewed more favorably than Trump
Republican Glenn Youngkin did his best to keep former President Donald Trump at arm’s length in his closely watched race for Virginia governor against Democrat Terry McAuliffe
7:26PM ( 36 minutes ago )