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FDA advisers recommend Pfizer vaccine for kids 5 and up

The overwhelming yes vote followed hours of discussion about the benefits and risks of expanding Covid-19 vaccine access to young kids.

(CN) — As the U.S. closes in on the one-year mark since adults first got vaccinated against Covid-19, offering the vaccine to children as young as 5 years old became a real, even imminent, possibility on Tuesday as experts paved the way toward vaccinating the youngest age group yet. 

After a long day of presentations and questions, the U.S. Food and Drug Administration’s independent advisory panel voted in favor of allowing the Pfizer Covid-19 vaccine to be used in the 28 million American kids ages 5 to 11 years old. 

Before voting on a single yes or no question — whether the benefits would outweigh the risks of expanding vaccine access to young children — panel members gave weight to the unknowns that come with new vaccines.

Some lamented the framing of the question itself. They wanted kids with health conditions, like transplant recipients or those with obesity, to be able to get vaccinated, but said that questions remain about how broadly the vaccine should be implemented in the youngest eligible.  

“I’m torn,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine in Boston. He said he believed the vaccine is effective, and wants to be able to offer it to parents who have been anxiously awaiting the opportunity. 

"I am just worried that, if we say yes, that the states are going to mandate administration of this vaccine for children to children, in order to go to school, and I do not agree with that," he said. "I think that would be an error at this time, until we get more information about the safety." 

Most vaccine mandates for adults came after the FDA fully approved the vaccine for those 18 and older.

Conversations about kids’ health are especially difficult, noted Dr. Amanda Cohn, chief medical officer of the National Center for Immunizations and Respiratory Diseases at the Centers for Disease Control and Prevention. 

“When we are talking about children we both don't accept death and severe outcomes in the same way that maybe we accept, to some degree, in older age groups. But we also don’t accept risks,” Cohn said.

While older adults are harder hit by the coronavirus compared to kids, 584 children have died from Covid-19, according to the latest data from the American Academy of Pediatrics and the Children’s Hospital Association. 

“To me, the question is pretty clear,” Cohn said. “We don't want children to be dying of Covid, even if it is far fewer children than adults, and we don’t want them in the ICU.” 

Panelists agreed, nearly unanimously, with 17 yes votes, zero no votes and one abstention. 

Dr. Eric J. Rubin, a physician at Boston's Brigham and Women’s Hospital and immunology professor at the Harvard T.H. Chan School of Public Health, noted that the lack of data on side effects would only improve by expanding the vaccine’s use. 

“We’re never going to learn about how safe this vaccine is unless we start giving it,” he said. “That’s just the way it goes.” 

Dr. James Hildreth Sr., a professor and chief executive officer of Meharry Medical College, stressed the need for follow-up studies by the CDC after the vaccine is rolled out to kids.

“I voted yes primarily because I want to make sure that the children who really need this vaccine — primarily the Black and brown children in our country — get the vaccine,” he said. “I hope that the [CDC’s Advisory Committee on Immunization Practices] will prioritize the vaccine, in some ways, and make sure that that actually happens.” 

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The FDA will still have to greenlight Pfizer’s request to modify its emergency use application; it was previously allowed for emergency use in kids ages 12 and up, and has been fully approved for adults since August. Then, the CDC will decide whether to recommend the shot for kids. It will meet next week. 

FDA panelists decided to vote in favor of authorizing the Pfizer Covid-19 vaccine for children ages 5 to 11 years old on Tuesday, Oct. 26, 2021. (Image via Courthouse News)

Children ages 5 to 11 years old account for 40% of all pediatric Covid-19 cases, and 9% of overall cases. Experts who addressed the FDA panel pointed out that, since kids are less likely to show symptoms of Covid-19, their rates of contracting the illness are probably underreported. 

Pediatric health experts have repeated the refrain that children are not simply small adults, and differences in their immune system warrant special clinical trials designed to determine safety in younger age groups. 

Pfizer, and its partner BioNTech, reported that its vaccine is more than 90% effective in 5- to 11-year-olds, based on a study of more than 2,200 children who received two doses — diluted to be one-third the size of what’s used in adults and adolescents — delivered three weeks apart. 

Assuming the next rounds of approval are a go, the shots could be available early next month. 

"If all goes well, and we get the regulatory approval and the recommendation from the CDC, it's entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November," said Dr. Anthony Fauci, the nation’s top infectious disease specialist, said on ABC's "This Week."

White House officials recently said they are ready to hit the ground running

"Should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms," said coronavirus response coordinator Jeff Zients during a news briefing last week. 

The U.S. has enough doses to cover the millions of kids in the younger age group, federal officials said, and will deploy supplies like smaller needles to the doctors and community health centers that need them. 

The vials of the diluted doses for children will have an orange cap to differentiate them from the adults’ purple-capped vials, Pfizer representatives told the FDA panel on Tuesday, and the shipping containers will also be distinct. 

During the panel’s public comment section, several speakers expressed hesitancy for allowing kids to get vaccinated. Some suggested that the emergency of the pandemic is behind us, so authorization would be unnecessarily hasty, and cited lower rates of severe Covid-19 symptoms in kids. 

Others including physicians, parents of kids under age 12, and representatives with the National Association of Pediatric Nurse Practitioners spoke in favor of access for youngsters. 

And a pediatrician, Dr. David Berger, advocated for doctors to approach hesitant parents in a non-threatening way, and let them make their own decisions. “No one benefits if we judge and ridicule each other,” he said. 

Following the anticipated authorization by regulators, schools will face a decision on whether to make vaccines for kids mandatory. Vaccine mandates for adults — including teachers, healthcare workers and public employees — have been the target of numerous lawsuits continuing to play out in federal court. 

In New York City, a group of teachers’ attempt to take down the city’s mandatory vaccine policy flopped at the Second Circuit. The same court will hear arguments this week from a group of health care workers taking aim at a statewide mandate. 

CDC Director Rochelle Walensky declined to weigh in during a recent "Fox News Sunday" interview on what schools should do about vaccine mandates for students. 

"Right now we are at authorization — we're having discussions about authorization,” she said. “I think we need to get children vaccinated through this authorization, and get to approval, before we can make a judgment there."

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