CDC endorsement opens COVID-19 vaccination to 28 million children aged 5 to 11 years
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CDC Director Rochelle P. Walensky, MD, MPH, endorsed her vaccine advisory committee’s unanimous vote on Tuesday to recommend the Pfizer-BioNTech pediatric COVID-19 vaccine, opening vaccination to millions of children aged 5 to 11 years.
The 14-0 vote by the CDC’s Advisory Committee on Immunization Practices came days after the FDA authorized the vaccine for emergency use in the younger age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19,” Walensky said in a statement. “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.”
At the outset of Tuesday’s meeting, Walensky urged ACIP members to “consider the risks and make a recommendation that is likely to have tremendous impact.”
“As you review the data today, it will be key to keep in mind the specific risks to children from this virus and this pandemic,” she said.
The regimen authorized by the FDA and now recommended by the ACIP is two shots given 21 days apart in children aged 5 to 11 years — the same schedule as in older age groups, but using a smaller dose: two 10 µg shots instead of two 30 µg shots.
The vaccine was already fully approved for people aged 16 years or older and has been available under an emergency use authorization to adolescents aged 12 to 15 years since May. The White House has plans to roll out and promote the pediatric vaccine.
According to Pfizer and BioNTech, a trial demonstrated that the vaccine is 90.7% effective at preventing laboratory-confirmed symptomatic COVID-19 occurring at least 7 days after a second dose (two-sided 95% CI, 67.7%-98.3%), with no reported cases of severe COVID-19, myocarditis, pericarditis, or multisystem inflammatory syndrome in children (MIS-C).
Yvonne Maldonado, MD, FAAP, professor of global health and pediatric infectious diseases at Stanford University School of Medicine and chair of the AAP’s committee on infectious diseases, read a statement on behalf of the AAP recommending the vaccine and its coadministration with routine childhood immunizations.
The statement stressed the importance of pediatricians promoting the vaccine to patients.
“Parents, caregivers and patients might have questions that need to be addressed related to the vaccine,” Maldonado said. “Pediatricians play an essential role in helping answer these questions as well as in reducing existing disparities and addressing any barriers to accessing COVID-19 vaccine in the community.”
Since the beginning of the pandemic, more than 1.9 million COVID-19 cases have been reported among children aged 5 to 11 years. Walensky said pediatric hospital admissions due to COVID-19 are higher than they were in any previous wave of a pandemic, reaching a rate of 25 hospitalizations per 100,000 persons per year in children between the ages of 5 to 11 years. More than 2,316 in that age group have been diagnosed with MIS-C, she reported.
Experts at the meeting discussed rare cases of myocarditis that have occurred among adolescents and adults receiving the larger dose of Pfizer-BioNTech’s messenger RNA vaccine — mostly males aged 12 to 29 years. No cases occurred in clinical trials among more than 3,000 children aged 5 to 11 years old, and CDC medical officer Sara Oliver, MD, MSPH, reported during the meeting that estimated risks for every million children in this age group would likely be lower than in a group including adolescents aged 12 to 17 years.
ACIP member Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, described her vote to recommend the vaccine.
“I think there’s an impression that we aren't parents,” Talbot said. “I have vaccinated my kids because I feel like it's safe, and I would not recommend something if I did not feel that way. And I think it's really important to just reiterate what many of us said: We are parents and we have given this to our children, because we have seen the devastation of this disease and the disruption in our kids’ lives. We’re looking forward to moving forward.”
[Editor’s note: This story was updated to reflect Walensky’s endorsement of the ACIP vote.]
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CDC. Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/acip/index.html. Accessed Nov. 2, 2021.
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