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CDC Approves Pfizer Shots for Kids Ages 5 to 11, Roll Out to Begin Wednesday

A nurse gives a girl a dose of the Pfizer vaccine at a clinic at Lyman High School in Florida. (Paul Hennessy / Getty Images)

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Updated, Nov. 2

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky on Tuesday evening the unanimous vote of a CDC vaccine advisory panel recommending Pfizer-BioNTech鈥檚 pediatric coronavirus vaccine for use in children ages 5 to 11. Her sign-off means shots can begin Wednesday for some 28 million children in this younger age group. The CDC approval comes after the Food and Drug Administration on Friday for emergency use in 5- to 11-year-olds. Children鈥檚 hospitals and pediatrician鈥檚 offices across the country told CNN that they have and would be ready to administer shots to children as soon as they got the green light. “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,” Walenksy said.

Members of a federal advisory panel voted overwhelmingly Tuesday evening to recommend the authorization of a pediatric dose of Pfizer-BioNTech鈥檚 coronavirus vaccine for children ages 5 to 11, setting in motion a process that could make shots available for the age group by next week.

The 17-0 vote, with one abstention, represents a key step toward vaccine access for approximately 28 million U.S. children 鈥 and means that virtually all K-12 students could soon be eligible for shots.

The Food and Drug Administration panel endorsed giving children one-third the dosage for adults in two shots spaced three weeks apart. The group鈥檚 vote is non-binding, but the FDA typically in the days after a decision, according to The New York Times.

Next, the Centers for Disease Control and Prevention has Nov. 2 and 3 meetings scheduled for their own panel of experts to weigh in on the matter, after which emergency use authorization could soon be issued.

FDA committee members cast their votes after considering the efficacy data of the Pfizer-BioNTech shots and the cumulative toll of COVID-19 on children and families.

Shots for kids were 91 percent effective at preventing infection, the pharmaceutical companies鈥 trial showed. Only three out of over 3,000 inoculated children experienced breakthrough infections, compared to over a dozen who had received the placebo.

Only three inoculated children out of over 3,000 experienced breakthrough infections in the Pfizer-BioNTech trial. (FDA via YouTube)

Immunity and side effects for 5- to 11-year-olds were comparable to those produced by the larger dose in 16- to 25-year-old patients, the data showed. No new safety problems or cases of heart inflammation were observed in the trial. Israeli studies have found myocarditis to occur in less than , so it鈥檚 possible the condition would have been too rare to have been detected in the main study.

However, even in worst-case scenarios where adverse cases run on the high side of what officials expect, the benefits of shots for kids still supersede the potential dangers, according to modeling presented by Hong Yang, senior advisor at the FDA鈥檚 Office of Biostatistics and Epidemiology.

鈥淭he benefits clearly outweigh the risks,鈥 she said.

Over the course of the pandemic, nearly 2 million children between the ages of 5 and 11 have fallen ill with the virus, 8,300 have been hospitalized, and close to 100 have died, making COVID-19 one of the top 10 causes of death among the age group, said Peter Marks, who heads the FDA division that oversees vaccine approvals.

In addition to preventing cases and hospitalizations, minimizing learning disruptions was a key consideration for advisory committee members. 

Since August, over 1 million K-12 students have been affected by school closures due to COVID, Dr. Fiona Havers, a viral diseases specialist at the CDC told committee members during the Tuesday hearing.

鈥淭he school closures and the disruption has been enormous,鈥 said the FDA鈥檚 Jeanette Lee. 鈥淲e have to weigh that against the benefits we would see [from] the vaccine.鈥

Over 1 million students have been affected by COVID school closures this year. (FDA via YouTube)

Randi Weingarten, president of the American Federation for Teachers, celebrated the panel鈥檚 recommendation as a win for school safety.

鈥淭his is huge news in our ongoing effort to keep our kids safe from COVID-19. For nearly two years, parents have been living in fear, worried that their child could get sick at school, day care, or in daily life, but now they finally have FDA-approved protection to add to the long list of vaccines we use to keep our children protected from transmissible diseases,鈥 she said in a statement. 鈥淓ducators, school staff and healthcare professionals are eager to work together with parents to help get America鈥檚 kids vaccinated in the places they trust, including public schools and community centers.鈥

At least one committee member, Cody Meissner, who ultimately voted to recommend the vaccine for authorization, expressed hesitation about how greenlighting shots for 5- to 11-year-olds may play out for school policy. 

鈥淚鈥檓 just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school and I do not agree with that. I think that would be an error at this time,鈥 he said during the Tuesday hearing.

Vaccine mandates have become a flashpoint in the ongoing culture wars now consuming school boards nationally. Only a handful of school districts, mostly in California, have enacted coronavirus vaccine requirements for eligible students. The Golden State鈥檚 two largest school systems, Los Angeles and San Diego, are currently defending their policies in court

California is also the only state to mandate shots for eligible students, though the policy will .

A third of parents with children ages 5 to 11 said they would get their child vaccinated 鈥渞ight away鈥 once they were eligible, according to a Sept. 30 , while a third said they would 鈥渨ait and see鈥 and a quarter said they would 鈥渄efinitely not鈥 vaccinate their younger children. A by 鈥嬧媡he COVID-19 Vaccine Education and Equity Project reported that two-thirds of parents with children in the age group said they would immunize them once the shots are authorized.

Vials of the pediatric vaccine will be colored orange, to differentiate from adult doses. (FDA via YouTube)

When shots do ultimately roll out for children, vials will be colored differently to avoid confusion with the more potent adult formula, said William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development.

Immediately after the FDA panel鈥檚 vote, Ashish Jha, dean of the Brown University School of Public Health, .

鈥淭hey got it right,鈥 he said.


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