CDC recommends Pfizer COVID-19 vaccines for kids ages 5 to 11

Walensky signs off on advisory committee's recommendations

The risk from COVID-19 is “too high and too devastating to our children and higher than many diseases we vaccinate our children for," CDC Director Rochelle Walensky said. (Tom Williams/CQ Roll Call file photo)
The risk from COVID-19 is “too high and too devastating to our children and higher than many diseases we vaccinate our children for," CDC Director Rochelle Walensky said. (Tom Williams/CQ Roll Call file photo)
Posted November 2, 2021 at 6:50pm, Updated at 9:35pm

Centers for Disease Control and Prevention Director Rochelle Walensky on Tuesday night recommended the use of Pfizer-BioNTech COVID-19 vaccines in children ages 5 to 11, offering protection from the virus to 28 million school-age kids who will be among the last Americans allowed to get shots.

Her decision mirrored recommendations that an independent advisory group voted to support, 14-0, earlier in the day.

“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.

Walensky opened the all-day advisory group meeting by acknowledging that COVID-19 risks are lower for children than adults but said the disease is still a threat. At least 94 children ages 5 to 11 had died of COVID-19 by mid-October, according to CDC data, nearly 2 million kids in that age group have been infected with the virus and 8,300 have been hospitalized.

"These most severe outcomes are generally rare," Walensky said. "Still, the risk is too high and too devastating to our children and higher than many diseases we vaccinate our children for."

Members of the CDC Advisory Committee on Immunization Practices overwhelmingly supported vaccinating young children against COVID-19.

"Clearly, the benefits of this vaccine far outweigh the risks," said ACIP member Jason Goldman, a pediatrician. He encouraged vaccine-hesitant parents to consider the long-term positive outcomes a vaccine could have for their kids, especially if COVID-19 is endemic and hangs around for many years.

In this year, to date, over 2,350 schools had unexpected closures due to COVID-19, impacting over 1.2 million students, Sara Oliver of the CDC's National Center on Birth Defects and Developmental Disabilities told the vaccine advisers. There are also several indirect impacts of COVID-19 on children, including worsening of kids' mental and emotional health, decreased physical activity, decreased health care utilization and a widening of education gaps, among other deleterious side effects.

The Food and Drug Administration granted emergency authorization for the pediatric vaccine last week, and the Biden administration promptly shipped out 15 million doses across the country. White House COVID-19 advisers had said they expected the pediatric COVID-19 vaccination effort to be up and running by Nov. 8 if Walensky accepted the independent advisers' recommendations.

Pfizer's COVID-19 vaccine for young kids is a smaller dose than the teen and adult COVID-19 vaccine, and comes in different packaging. The vaccine is 90.7 percent effective at preventing infection in young kids. Adults and teens receive two 30-microgram doses of the Pfizer vaccine, but kids ages 5 to 11 would receive two 10-microgram doses.

More than 100 children's hospitals across the country plan to set up vaccination sites, and jurisdictions are relying on pharmacies and pediatricians to administer most of the shots. Seventy percent of the CDC's Vaccines for Children program providers are already enrolled as COVID-19 vaccine providers.

But shot uptake may not be very high among kids in this age group. As little as 34 percent of parents plan to get their kids vaccinated, according to polling, the CDC's Sara Oliver told the committee. Many parents cite concerns about possible short- or long-term effects of vaccinating their kids as a reason not to get the shots, while others noted their own vaccination status or a provider's recommendations.

Beth Bell, an advisory committee member and professor of global health at the University of Washington, said the evidence is so strongly in favor of authorizing the shot for kids that she felt a responsibility to make the vaccine available to children and their parents.

"We do have a pretty robust view of the situation at this moment, and I think this is a huge step forward for children and parents, and I support the recommendation," Bell said.

The committee has more information and data for the Pfizer COVID-19 vaccine in young kids than they usually do for new vaccines for other conditions, said committee member Lynn Bahta, an epidemiologist with the Minnesota Department of Health.

"I think we know more than we don't know, and there are huge commitments to filling those gaps," Bhata said while voicing her support of the shot.

Infection and safety data

Data show children ages 5 to 11 are at least as likely to be infected with COVID-19 as adults, said Jefferson Jones, who presented to the committee on behalf of the CDC's National Center for Immunization and Respiratory Diseases. Over 1.9 million cases were reported for this age group, but data suggest that infections in children are less likely to be reported than those in adults.

Blood testing data in kids indicates 36 to 40 percent of kids ages 5 to 11 have already had COVID-19. This is higher than estimates in adults but similar to kids ages 12 to 17. But these estimates may not represent the general population and evidence of previous infection isn't proof of current protection.

MIS-C, also known as multisystem inflammatory syndrome in children, occurs in about one in 3,200 COVID-19 infections. Nationally, 5,217 cases have been reported, and children ages 5 to 11 are most likely to be affected by it. A disproportionate 61 percent of children impacted by MIS-C are Hispanic or Black.

Beyond MIS-C, other post-COVID-19 issues are less common in children than adults, but more studies are needed.

The risk of heart inflammation such as myocarditis after COVID-19 vaccination is relatively low, said Matt Oster, who presented on behalf of the CDC's National Center on Birth Defects and Developmental Disabilities.

There were 1,640 total preliminary reports of myocarditis in vaccinated people under age 30, but only 877 met the case definition. In children, the incidence of myocarditis was 0.8 per 100,000, and 66 percent of people who contracted heart inflammation were male.

The CDC is assessing the long-term impacts of myocarditis after COVID-19 vaccination. Of the roughly 250 patients it has followed up with, half reported no symptoms within the last two weeks to three months after getting myocarditis. Oster said he believes there is a lower risk of myocarditis in kids ages 5 to 11, and the risk of myocarditis after vaccination in this age group is lower than the risk of experiencing the inflammation after having COVID-19.

There was a lot of interest in what to do with children who turn 12 in the middle of their vaccination series. Alejandra Gurtman, Pfizer's vice president of vaccine research and development, told the committee some 11-year-olds turned 12 during the middle of the Pfizer COVID-19 vaccine trial, but they stayed on the smaller 10-microgram dose.

The FDA's Doran Fink said if an 11-year-old will turn 12 after the first shot, the child can receive a 10-microgram dose for the initial dose followed by the 30-microgram for the second dose. But he suggested ACIP make a firm recommendation.

Kate Woodworth of the CDC's National Center for Emerging and Zoonotic Infectious Diseases said children should receive the age-appropriate vaccine formulation regardless of their size or weight. Vaccination is recommended regardless of whether a kid was previously infected with the virus.

If a child inadvertently receives an adult dose of the Pfizer dose for the first or second dose, it should be fine and the child should be considered fully vaccinated after completing the two-dose series, Woodworth said.