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Updated, Nov. 2
Centers for Disease Control and Prevention Director Dr. Rochelle Walensky on Tuesday evening endorsed the unanimous vote of a CDC vaccine advisory panel recommending Pfizer-BioNTech’s 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 authorized the shots for emergency use in 5- to 11-year-olds. Children’s hospitals and pediatrician’s offices across the country told CNN that they have received their doses 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’s 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 — 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’s vote is non-binding, but the FDA typically follows its recommendations 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’ trial showed. Only three out of over 3,000 inoculated children experienced breakthrough infections, compared to over a dozen who had received the placebo.
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 1 in 5,000 vaccinated teenage males, so it’s 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’s Office of Biostatistics and Epidemiology.
“The benefits clearly outweigh the risks,” 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.
“The school closures and the disruption has been enormous,” said the FDA’s Jeanette Lee. “We have to weigh that against the benefits we would see [from] the vaccine.”
Randi Weingarten, president of the American Federation for Teachers, celebrated the panel’s recommendation as a win for school safety.
“This 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,” she said in a statement. “Educators, school staff and healthcare professionals are eager to work together with parents to help get America’s kids vaccinated in the places they trust, including public schools and community centers.”
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.
“I’m 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,” 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’s 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 likely not go into effect until July 2022.
A third of parents with children ages 5 to 11 said they would get their child vaccinated “right away” once they were eligible, according to a Sept. 30 Kaiser Family Foundation survey, while a third said they would “wait and see” and a quarter said they would “definitely not” vaccinate their younger children. A more recent survey by the 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.
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’s vote, Ashish Jha, dean of the Brown University School of Public Health, took to Twitter.
“They got it right,” he said.
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