Your Questions About the Coronavirus Vaccine in Children, Answered

The CDC has recommended the Pfizer-BioNTech vaccine for use in kids ages 5 to 11, making these children now eligible to get vaccinated

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On Nov. 2, Centers for Disease Control and Prevention Director Rochelle Walensky issued the agency’s official recommendation for the Pfizer-BioNTech COVID-19 vaccine for use in children ages 5 to 11, just hours after the CDC’s Advisory Committee on Immunization Practices voted to recommend the vaccine for this age group. The Food and Drug Administration had already authorized this vaccine for this age group on Oct. 29, following the earlier recommendation of an FDA advisory panel.

Vaccines will be available for 5- to 11-year-olds starting this week, with distribution scaling up next week, according to a CDC press release.

“Today is a monumental day in the course of this pandemic,” Walensky said while addressing the ACIP at the start of the Nov. 2 meeting.

In early May, the FDA authorized the use of the Pfizer-BioNTech coronavirus vaccine in children ages 12 to 15. As of Nov. 2, 56.7 percent of 12- to 15-year-olds had received at least one vaccine dose, and 47.5 percent of this population was fully vaccinated, according to data from the CDC.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” acting FDA Commissioner Janet Woodcock, MD, said in a press release Oct. 29. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”

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“If you want your child to go to school, if you want them to be safe, to have the normal social experiences that are important to childhood, please protect them by getting them vaccinated,” says Gregory Poland, MD, director of the Vaccine Research Group at the Mayo Clinic in Rochester, Minn., who studies vaccine response in adults and children.

Several members of the FDA’s advisory panel said vaccinating 5- to 11-year-olds was a difficult decision, mostly because of the potential unknown risk of myocarditis, which has been a rare adverse side effect in older adolescents and young adults. Plus, the CDC estimates that 40 percent of this population has already been infected with COVID-19, meaning that many already have some protection against infection. The 40 percent number may be an overestimate, however, according to a CDC representative speaking at the Nov. 2 meeting, because it’s based on children who got blood drawn for a medical reason.

In the end, most members of the FDA advisory committee said they thought the benefits of vaccination for this group outweighed the risks, especially given that younger children will be getting a lower dose of vaccine than older children and given that the myocarditis risk for children ages 12 to 15 appears to be lower than the risk for those 16 to 18 and for young adults.

At least 94 children between 5 and 11 years old have died of COVID-19 in the U.S., and “we don’t want children to be dying of COVID, even if it is far fewer children than adults—and we don’t want them in the ICU,” Amanda Cohn, MD, senior advisor to the CDC director, said during the Oct. 26 advisory panel discussion. Some kids might not need to be vaccinated, but there are a lot of kids at higher risk, for whom this could make a significant difference and protect health and life, said James Hildreth, MD, PhD, president of Meharry Medical College in Nashville, Tenn. “I voted yes to make sure those who really need it can get it,” he said.

To better understand what we know about COVID-19 vaccines for children, CR consulted with experts and reviewed the available data. Here are answers to some common questions parents may have.

Do We Really Need COVID-19 Vaccines for Kids?

Yes. While kids are less likely to develop severe cases of COVID-19 than adults, they are just as likely to get infected. Some require hospitalization, and some have died. Adolescents have been more likely to develop severe disease like adults, says Kathryn Edwards, MD, scientific director of the Vanderbilt Vaccine Research Program and a professor of pediatrics. Vaccination will help protect against severe disease and death.

In recent months, children have been far more likely to get infected. That’s partially because as adults get vaccinated, they’re less likely to get infected, making children a greater proportion of overall cases. But another reason, Poland says, is that variants of the virus now circulating are more infectious. And that makes vaccinating children, who have always faced some risk from the virus, even more urgent.

The emergence of the highly contagious delta variant of the coronavirus has led to a surge in cases for everyone, kids included, says Tina Tan, MD, a pediatric infectious disease specialist and professor of pediatrics at Northwestern University in Chicago. “For the two weeks ending Sept. 9, there were over 500,000 cases of COVID-19 in children,” she says. At the end of October, the American Academy of Pediatrics reported that 24 percent of COVID-19 cases in the previous week were in children, representing 100,630 cases.

Even if delta isn’t more dangerous for kids, the increase in contagiousness means a lot more kids are ending up in the hospital, says Sean O’Leary, MD, a professor of pediatrics at the University of Colorado School of Medicine and an infectious disease specialist at Children’s Hospital Colorado. That highlights the urgency of getting more people—kids and adults—vaccinated. The surges in pediatric hospitalizations are especially bad in places with lower vaccination rates for adults and adolescents, he says.

During the ACIP Nov. 2 meeting, the agency reported that there have been 1.9 million cases in children ages 5 to 11, leading to 8,300 hospitalizations; 2,316 cases of multisystem inflammatory syndrome, a condition where parts of the body—including the heart, lungs, brain, and other organs—can become inflamed, potentially leading to organ damage or death; and 94 deaths.

Vaccination also helps prevent other serious outcomes in children, Edwards says. Many of these kids—including many who were never hospitalized—deal with lingering symptoms that can persist long after infection, Tan says. A national survey in the U.K. found that 7 to 8 percent of children with COVID-19 had symptoms that continued more than 12 weeks after their initial diagnosis, a CDC official said during the FDA advisory group’s Oct. 26 discussion.

During the Nov. 2 ACIP meeting, professional organizations including the American Academy of Pediatrics, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners, and the Pediatric Infectious Diseases Society all issued statements strongly in favor of vaccination for all children without contraindications ages 5 and older.

Are the Vaccines Effective in Kids?

So far, efficacy data on the Pfizer-BioNTech vaccine in children looks “stellar,” says Poland at the Mayo Clinic. (Poland has consulted with Pfizer, Moderna, and Johnson & Johnson on the development of their vaccines.)

According to Pfizer and BioNTech, a clinical trial of that vaccine in 2,260 children ages 12 to 15 found it 100 percent effective at preventing COVID-19. Children in that age group had even higher levels of antibodies in response to the vaccine than 16- to 25-year-olds.

In a Sept. 20 announcement, Pfizer and BioNTech said there were 2,268 kids ages 5 to 11 in their more recent trial. These kids also generated antibodies at least as strong as those in people ages 16 to 25, with a smaller dose of the vaccine, according to the announcement. The data from this trial reported Oct. 22 indicate that this vaccine is 90.7 percent effective at preventing symptomatic infection with COVID-19 in this age group. In an analysis of Pfizer and BioNTech’s trial data, FDA scientists wrote that the benefits of vaccination for kids ages 5 to 11 appeared to outweigh the risks for this group.

The companies hope to have data on vaccine effectiveness in kids ages 2 through 4 before the end of the year, and in kids ages 6 months through 2 years early next year.

In May, Moderna announced that its clinical trial of 3,732 people ages 12 to 17 showed that adolescent immune systems responded to its vaccine at least as well as the immune systems of adults. The company also reported that its vaccine, which uses technology similar to the Pfizer-BioNTech vaccine’s, was not only 100 percent effective two weeks after the second dose but also 93 percent effective two weeks after the first dose. On Oct. 25, Moderna announced that it had trial data showing that giving kids ages 6 to 11 a dose half the size of the dose given to adults generated a stronger level of antibodies than the level that young adults generate with a regular-sized vaccine dose.

On June 10, Moderna requested FDA authorization for use of its vaccine in people ages 12 to 17, after reporting that clinical trials showed it was effective in adolescents. The FDA has not yet granted that authorization. On Oct. 31, Moderna announced that the FDA had informed the company that the agency needed more time to evaluate international reports of myocarditis risk and that it might not finish the review before the end of this year. Canada’s public health agency has said it found a relatively higher risk of myocarditis with the Moderna vaccine compared with Pfizer, and in October, Denmark and Sweden paused the use of the Moderna vaccine in younger age groups because of potential cardiovascular side effects. Moderna said it would not request an EUA for children ages 6 to 11 until the FDA review is complete.

It’s likely that in the real world the efficacy of these vaccines may vary slightly, but they will likely remain very protective, Poland says. Information on the effectiveness of vaccines made by Johnson & Johnson and Novavax in children may be available soon, too, he says. 

Do Kids Get the Same Shot As Adults?

Older kids do, though younger kids will get smaller doses.

In Pfizer-BioNTech’s clinical trial, 12- to 15-year-olds received the same vaccine and dosages as adults, on the same schedule, with a second dose three weeks after the first. The FDA’s authorization for the Pfizer-BioNTech vaccine allows 12- to 15-year-olds to get the same dose as adults.

In children ages 5 to 11, Pfizer and BioNTech said a 10-microgram dose (one-third of the dose given to older children and adults) appeared to provide as much protection as the larger dose gives adults. This is the dose authorized by the FDA and recommended by the CDC. Like adults, kids are supposed to get two doses three weeks apart. Doses for children ages 5 to 11 come from orange-capped vials. (The vials for older children and adults have purple caps.) The vaccines for these children will be available in pediatrician offices, clinics, and pharmacies.

In children ages 6 months to 4 years, the companies are testing a 3-mcg dose.

In Moderna’s trial, 12- to 17-year-olds received the same doses as adults. But in their trial with kids ages 6 to 11, those children received a 50-microgram dose, instead of the 100-microgram dose given to adults.

Are the Vaccines Safe for Kids?

Common side effects reported in children so far are similar to those in adults: injection site pain, fatigue, headaches, muscle aches, chills, joint pain, and fever. And as in other age groups, these were “well tolerated” in 12- to 15-year-olds, Pfizer and BioNTech say.

The same sorts of symptoms were seen in 12- to 17-year-olds who received the Moderna vaccine, according to the company, with headaches, fatigue, achiness, and chills reported.

“The reaction profiles were pretty comparable to what we see in adults,” says Kathryn Edwards at Vanderbilt.

In mid-May, the CDC announced that it was investigating rare reports of heart inflammation—myocarditis and pericarditis—that have occurred after coronavirus vaccination, and the agency released additional data in June.

These cases have occurred mostly in male patients and have been more common after the second dose than the first. Importantly, there have been more reports of suspected myocarditis in people ages 16 to 24 after vaccination than would be expected normally for that population, according to CDC data.

But while it’s important that the CDC is transparent about these investigations, parents should understand that these events are still extremely rare, says David Parra, MD, a pediatric cardiologist and an associate professor of pediatrics at Vanderbilt University. According to a June CDC study, there would be approximately 39 to 47 myocarditis cases in males ages 12 to 29 for every million second doses of the vaccine.

A risk-benefit analysis by the CDC suggests that for every million second doses of vaccine given to males ages 12 to 17, there could be 56 to 69 cases of myocarditis—but that these vaccinations would prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 intensive care unit admissions, and two deaths.

Children ages 12 to 15 appear to have lower rates of myocarditis after vaccination than people ages 16 to 29, something that several members of the FDA advisory panel said made them more comfortable recommending authorization of the vaccine for kids ages 5 to 11. While the cause of myocarditis in young men is still unknown, some research suggests that it could be linked to testosterone, which could make the risk for younger, prepubescent children lower.

It’s expected that younger children will be less likely to develop myocarditis, according to Matthew Oster, MD, a pediatric cardiologist at Children’s Healthcare of Atlanta and a member of the CDC’s COVID-19 task force, who presented myocarditis data on children ages 5 to 11 at the Nov. 2 ACIP meeting. The data also appears to indicate that for adolescents and young adults, vaccine-associated myocarditis is milder and resolves more quickly than traditional myocarditis, Oster said.

Still, in some countries, including the U.K. and Norway, health officials have recommended only a single dose for adolescents for now, to lessen the risk of side effects.

We also know that COVID-19 itself can cause inflammation in the heart and other organs, Parra says. “Vaccination is really important, and from what we know, the risks of COVID are much higher than the risks of vaccination,” he says. According to a September CDC report, kids younger than 16 who get COVID-19 are 37 times more likely to develop myocarditis than kids without COVID-19. That’s a significantly higher risk than the myocarditis risk associated with vaccination. “Getting COVID is much riskier to the heart,” Oster said at the CDC discussion.

Poland says that experts will be watching closely to ensure that side effects aren’t a bigger problem for younger children. He adds that one reason to test lower dosages is to try to minimize side effects for the youngest children.

When Will Younger Children Be Eligible?

Children ages 5 to 11 will be able to start getting shots this week, the CDC said when announcing Director Walensky’s endorsement of the ACIP’s recommendation on Nov. 2.

Data on kids younger than 5 is expected before the end of the year or in early 2022. But the FDA and CDC need to review the data before recommending vaccinations for younger kids. “You want to show the vaccine is safe and effective in this population,” says Tan at Northwestern University.

Edwards says exactly when younger children will be eligible depends on how the trials go. “We’re all working really hard to make sure the vaccines are safe and effective,” she says. “We will not go too fast. We will go in a careful, cautious manner.” 

Will Schools Require Kids to Be Vaccinated Against COVID-19?

More than 1,000 colleges and universities in the U.S. have required students to be vaccinated against COVID-19, according to a count by The Chronicle of Higher Education. Some high schools have as well. All students 12 and older in Los Angeles public schools, for example, must be vaccinated by Jan. 10, 2022.

Schools that serve younger children already often require proof of various immunizations before children enroll, but it’s not yet clear whether a COVID-19 vaccine will become one of them.

Right now, COVID-19 vaccines have an emergency use authorization from the FDA for kids under 16. Until vaccines receive full approval for younger age groups, Poland says he thinks most schools probably won’t require kids to have one. But after the FDA fully approves the vaccines for children, many schools are likely to require proof of vaccination, he says.

Edwards says she hopes that people are persuaded to get children vaccinated based on the “incredible success” we’ve seen the vaccines have at preventing disease so far. 

Editor’s Note: This article has been updated to include new data and information from the CDC, the FDA, Pfizer-BioNTech, and Moderna, as well as additional reporting. It was originally published May 4, 2021. 

Head shot image of CRO Health editor Kevin Loria

Kevin Loria

I'm a science journalist who writes about health for Consumer Reports. I'm interested in finding the ways that people can transform their health for the better and in calling out the systems, companies, and policies that expose patients to unnecessary harm. As a dad, I spend most of my free time trying to keep up with a toddler, but I also enjoy exploring the outdoors whenever possible. Follow me on Twitter (@kevloria).