Updated: November 2, 2021 9:04 PM EDT | Originally published: November 2, 2021 7:20 PM EDT

The Centers for Disease Control and Prevention (CDC) today recommended the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 5 and 11. CDC director Dr. Rochelle Walensky followed the advice of the agency’s advisory committee in deciding to expand use of the vaccine to young children.

“We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine,” she said in a statement. “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 followed the advice of a panel of experts, which met earlier on Nov. 2 to review data on the safety and efficacy of the Pfizer-BioNTech vaccine for kids. In a unanimous vote, the committee decided to recommend the shot for the youngest group yet to get immunized against COVID-19.

The CDC committee’s recommendation follows last week’s decision by the Food and Drug Administration (FDA) to authorize the Pfizer-BioNTech vaccine for the youngest population yet. The vaccine for this age group is one-third the adult dose and will be given in two doses, one month apart. The FDA authorized the shot for the entire age group, but it was up to the CDC to determine whether all children ages 5 to 11 should get vaccinated, or whether only a subset should.

Ultimately, the CDC committee decided that all kids in that age group—about 28 million—should get vaccinated against COVID-19. The members weighed evidence presented by Pfizer-BioNTech as well as data from CDC experts on how prevalent COVID-19 infections are among this population of children, and how the disease affects them. CDC scientists noted that 1.9 millions cases of COVID-19 have occurred among children ages 5 to 11, and that while most cases are mild, 8,300 children have been hospitalized and 94 have died of the disease so far.

Members reviewed data from two studies conducted by Pfizer-BioNTech that involved nearly 4,500 children. Those studies showed overall that children getting the vaccine were less likely to get COVID-19, and if they did, they were less likely to experience severe disease or require hospitalization. There were no deaths associated with the vaccine in these studies.

That data needed to be balanced against the known side effects of the vaccine, which include Multisystem Inflammatory Syndrome in Children (MIS-C)—a rare condition that causes fever, loss of blood pressure and damage to different organs including the liver—and myocarditis, an inflammation of the heart muscle. CDC scientists analyzed the rates of these complications among children getting vaccinated as well as those who developed COVID-19, and determined that the risk of adverse events was higher among children infected with SARS-CoV-2 than among those who were vaccinated.

The CDC scientists and committee members acknowledged, however, that because younger children have not been eligible for vaccination yet, not much data is available on risks among this population—the Pfizer-BioNTech trials only included several thousand children. Still, as CDC panel member Lynn Bahta, from the Minnesota Department of Health, said, “We know more than what we don’t know. And we have a huge commitment to filling in those gaps.”

CDC officials noted that after the vaccine is rolled out to this population, the agency’s scientists will continue to monitor for any potential safety concerns through a number of different reporting systems, including ones that the public can access, such as V-safe, which is a smartphone tool.

The CDC team also presented convincing models that showed the impact vaccinating children could have on disease burden. For every million vaccinations among this age group, 18,000 cases of COVID-19 could be prevented, as well as 80 hospitalizations and 26 ICU admissions, the team predicted. When compared to other childhood vaccinations, COVID-19 immunization could prevent three times as many deaths as other vaccinations that children already receive.

“When do you know enough? That’s the question,” says Dr. Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia and a member of the FDA advisory committee that recommended the vaccine for children ages 5 to 11. “It’s not about when you know everything, but do you know enough? There’s a huge platform of safety data from 16 to 17 year olds, and also children over 12, and that’s a lot of information about safety.”

Still, Offit says parents are more hesitant about vaccinating their kids than they were about getting vaccinated themselves. The CDC team presented results from a survey showing that only around half of parents with children in this age group said they would definitely or probably get their kid vaccinated. “We recognize that there are parents out there with concerns about COVID-19 vaccines,” said Dr. Matthew Daley, senior investigator at Kaiser Permanente Colorado and a CDC committee member. “We hear you loud and clear and know that you want the best for your child. And we encourage you to talk to your family physician or pediatrician.” He also encouraged doctors to engage with parents to get families the information they need to make an informed decision about vaccinating their children.

The CDC will provide doctors with more detailed guidance about how to immunize children who fall in between the age ranges for the two different doses. While 5 to 11 year olds will receive one-third the dose given to adults, 12 to 15 year olds receive the full dose. So the agency will supply guidance on, for example, whether an 11 year old who gets an initial smaller dose and then turns 12 before the second shot should get a full dose. The experts noted that vaccine doses are allocated by age and not dependent on body size or weight.

The panel’s recommendation means that pediatricians and family doctors will likely bear the brunt of calls and questions from parents, as most families have said those offices are where they intend to have their kids vaccinated. The Biden Administration is prepared to ship doses directly to hospitals, community clinics and pharmacies as well as to more doctors’ offices in the coming weeks. Pediatric doses will be labelled differently to distinguish them from adult-sized doses, with orange as opposed to purple caps. At Walgreens, pharmacists are preparing to start vaccinating children on Nov. 6, and parents can start making appointments online for their children immediately.

“I am doing this to prevent number 95, the 95th death,” said Veronica McNally, president and CEO of the Franny Strong Foundation and the consumer advocate member of the committee, in explaining why she voted to recommend universal vaccination for 5 to 11 year olds. “To say this disease is not impacting kids is not an accurate statement, and I hope people understand that.”

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