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Children ages 5-11 should be vaccinated against COVID-19 with the Pfizer/BioNTech vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) said on Tuesday.

ACIP voted 14-0 to recommend vaccinating this population with a two-dose regimen of 10 μg apiece, 21 days apart, citing the favorable benefit-risk association, the idea of restoring normalcy to children, and especially the extensive data presented by FDA and CDC staff.

Several hours later, CDC Director Rochelle Walensky, MD, signed these recommendations. Earlier in the day, she once again addressed the panel.

"Today is a monumental day in the course of this pandemic and one that many of us will be very eager to see," she said, adding that since the first vaccines were authorized for ages 16 and up, the question has been when protection might be expanded to younger children.

This is a "recommendation likely to have tremendous impact," Walensky said. She said she was eager to see how committee members "interpret what we know and acknowledge areas of uncertainty."

Walensky also said that 745 children have died of COVID during the pandemic, including 94 children ages 5-11, and over 2,300 children in this population have been diagnosed with multi-system inflammatory syndrome (MIS-C).

Many committee members spoke as parents and grandparents and explained how they have vaccinated their children and grandchildren. Consumer representative Veronica McNally, JD, got a bit choked up when talking about how she would vaccinate her child after this recommendation, and would do so to prevent "the 95th death" in a child.

In an unusual move, several liaison representatives from the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), National Association of Pediatric Nurse Practitioners (NAPNAP), and the Pediatric Infectious Diseases Society (PIDS) read statements in support of vaccination for this age group prior to the ACIP vote.

Even normally skeptical ACIP members were on the side of the vaccine. Sarah Long, MD, of Drexel University in Philadelphia, who previously expressed hesitation about risk of vaccine-associated myocarditis in other age groups, said she was "very supportive" of this recommendation, given the large amount of data presented by the FDA and manufacturer, as well as because of the lower dose.

"We have one more vaccine that saves the lives of children and we should be very confident to employ it to the maximum to do what it was meant to do without significant concerns of serious adverse events," she said.

All eyes were on one rare side effect, vaccine-associated myocarditis. CDC staff presented data on vaccine-associated myocarditis showing that it occurs less frequently in younger children, and no cases of myocarditis were observed within the clinical trial.

Matthew Oster, MD, of the CDC, noted the incidence of vaccine-associated myocarditis would be about one in every 10,000 to 20,000 individuals for this age group. McNally asked Oster point-blank if given the information today, in his medical opinion, do the benefits outweigh the risks of vaccination.

"In my opinion, yes," Oster said.

While ACIP members were united in their support for the vaccine, Matthew Daley, MD, of Kaiser Permanente Colorado in Aurora, acknowledged those who are against this recommendation.

"I feel like collectively we're stronger when we hear from dissenting voices," he said. "Of course, you only want what's best for your child. It's understandable that you have questions given" the disinformation campaign against the vaccine, Daley said.

Several ACIP members stressed the importance of talking to pediatricians about the vaccine, and pediatricians recommending the vaccine to their patients.

We will "end this pandemic with science leading the charge," Walensky said.

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