Student Well-Being

COVID-19 Vaccine for Children 5 to 11 Clears Hurdle to Emergency Approval

By Arianna Prothero — October 26, 2021 4 min read
This October 2021 photo provided by Pfizer shows kid-sized doses of its COVID-19 vaccine in Puurs, Belgium. The vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Oct. 22, 2021, as the U.S. considers opening vaccinations to that age group.
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COVID-19 vaccines for children 5 to 11 cleared a major hurdle from the Food and Drug Administration Tuesday, placing a vaccine on the path to emergency approval in the near future.

A key FDA advisory committee made up of independent experts has recommended that the agency grant emergency use authorization to the vaccine developed by Pfizer and BioNTech.

The FDA’s Vaccines and Related Biological Products Advisory Committee’s decision is not binding, although the FDA is expected to follow the recommendation, which would likely make the vaccine available as early as next week.

If ultimately approved for emergency use, the Pfizer shot would be the first COVID-19 vaccine available to children 5 to 11, marking a turning point for the nation’s elementary and middle schools that have had to navigate the challenges of in-person and remote learning through a pandemic with no vaccine for younger students.

Trial data found that the COVID-19 vaccine for younger children is 91 percent effective at preventing symptomatic infection. Side effects were similar to those in adults including fatigue, fever, chills, muscle pain, and redness and swelling at the injection site.

The dose for younger children will be one-third that of adults and will be administered as a two-dose regime, three weeks apart.

Concerns about premature use of vaccine mandates in schools

The key question doctors on the advisory committee addressed was whether the benefits of the vaccine outweighed the risks, especially as new coronavirus cases are waning nationally, and younger children are generally at lower risk of developing severe disease from the coronavirus.

While several committee members said that a clear benefit of the vaccine would be to ease pressure on schools and make in-person learning safer, others expressed concern that emergency use authorization would lead to schools prematurely mandating the vaccine for children.

“I think that will be an error at this time until we get more information about the safety,” said Dr. Cody Meisner, the director of the Pediatric Infectious Disease Tufts Medical Center in Boston.

One potential risk is myocarditis, a condition that causes heart inflammation and is linked to the COVID-19 vaccines using mRNA technology—or those developed by Pfizer and Moderna.

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Image of a young boy in a pediatrician's office.
Geber86/E+

While no cases of myocarditis or pericarditis—a related medical issue—were detected in Pfizer’s trial in 5- to 11-year-olds, the vaccine has caused these conditions, in rare instances, among older age groups, with teen boys appearing to be the most at risk.

Among children ages 5 to 11, 1.9 million have gotten COVID-19 and more than 8,300 have been hospitalized, according to the U.S. Centers for Disease Control.

Despite concerns over myocarditis, the FDA said last week in an analysis of the trial data that the benefits of the vaccine—including in-person learning, increased herd immunity, lowering transmission, and protecting vulnerable populations—outweigh the risks.

Ultimately, 17 of the 18 members of the committee voted to recommend the Pfizer vaccine for 5- to 11-year-olds. One member abstained. While some members of the FDA vaccine advisory committee said they were not sure if the benefits outweighed the risks for all children at this point, based on the trial data, they did not want to limit access to the vaccine to children with underlying health conditions or families who have medically vulnerable members in their household.

In addition to Pfizer’s vaccine likely becoming the first vaccine available for children as young as 5 years, it is the only vaccine to have received emergency approval for children as young as 12 and full approval from the FDA for people 16 and older.

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Corey Ruth, a student at McDonogh 35 high school in Louisiana, was unsure of getting the COVID-19 vaccine until his athletic trainer talked to him about it.
Corey Ruth, a student at McDonogh 35 high school in Louisiana, was unsure about getting the COVID-19 vaccine until his athletic trainer talked to him.
Harlin Miller for Education Week

However, even once the vaccine is authorized, hurdles remain in a widescale effort to get younger schoolchildren vaccinated. While there are many parents eagerly awaiting approval of the vaccine for younger children, many other parents remain uncertain.

Thirty-four percent of parents of children aged 5 to 11 polled by the Kaiser Family Foundation in September said they would get the Pfizer vaccine as soon as it became available. Another 32 percent said they plan to take a wait-and-see approach.

Still other parents are outright opposed to the vaccine, 24 percent, according to the Kaiser poll. The FDA and members of its advisory committee were swamped in comments and emails over the weekend from people opposing any recommendation of the vaccine in an organized effort of parents and activists.

As a handful of school districts and one state, California, have moved to require COVID-19 vaccines for schoolchildren, parents opposed to vaccinating their children are concerned that with FDA emergency approval mandates may soon follow.

“I’ve had over 4,000 emails asking me to vote no,” said Dr. Jay Portnoy, the consumer representative for the advisory committee. “But I feel like I have to represent the parents who I see every day in my clinic who are terrified to send their kids to school.” Especially, he added, when many adults are not willing to follow other mitigation measures such as wearing masks.

In terms of the logistics of making sure there are vaccines available for all 28 million 5- to 11-year-olds in the U.S., the White House recently released a plan to administer vaccines to this age group primarily through doctors offices and pharmacies. Schools also play a key role in the Biden Administration’s plan through countering vaccine misinformation and by providing vaccines on school campuses in partnership with local health providers.

Should the FDA authorize the vaccine for 5- to 11-year-olds, the CDC will then weigh in on whether to recommend the vaccine for this age group.

The FDA will continue to track the safety of the vaccines after emergency use authorization.

Kids & the COVID-19 Vaccine: Must-Reads

Looking for more information on COVID-19 vaccinations and kids? Browse this curated list of news, advice, and more, broken down by topic. For the latest, view Education Week’s ongoing vaccine coverage.

The Latest

Student Well-Being Kids and COVID-19 Vaccines: The Latest News
April 13, 2021
54 min read

Vaccine Administration

Ticket number 937 sits on a COVID-19 vaccination at the drive-thru vaccination site in the Coweta County Fairgrounds on Jan. 14, 2021, in Newnan, Ga.
A ticket number sits on a COVID-19 vaccination at the drive-thru vaccination site in the Coweta County Fairgrounds in Newnan, Ga.
Curtis Compton/Atlanta Journal-Constitution via AP
Federal White House Outlines COVID-19 Vaccination Plans for Kids 5-11
Evie Blad, October 20, 2021
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Cole Rodriguez, a 15-year-old student at Topeka West, gets a COVID-19 vaccine Monday, Aug. 9, 2021 at Topeka High School's vaccine clinic.
Cole Rodriguez, a 15-year-old student, gets a COVID-19 vaccine at Topeka High School's vaccine clinic.
Evert Nelson/The Topeka Capital-Journal via AP

Communicating About the Vaccine

Image of a stethescope, teddy bear, and vaccine syringe.
Milena Khosroshvili/iStock/Getty
Cheryl Watson-Harris, superintendent of the DeKalb County School District in DeKalb, Ga.
Cheryl Watson-Harris, superintendent of the DeKalb County School District in Georgia.
Dustin Chambers for Education Week
Corey Ruth, a student at McDonogh 35 high school in Louisiana, was unsure of getting the COVID-19 vaccine until his athletic trainer talked to him about it.
Corey Ruth, a student at McDonogh 35 high school in Louisiana, was unsure about getting the COVID-19 vaccine until his athletic trainer talked to him.
Harlin Miller for Education Week

Vaccine Mandates

Opponents of legislation that tightened  rules on exemptions for vaccinations demonstrate outside the office of California Gov. Gavin Newsom in Sacramento, Calif., in Sept. 2019. Medical exemptions in California more than tripled in the three years after they became the only allowable reason for a student to be unvaccinated.
Opponents of legislation that tightened rules on exemptions for vaccinations demonstrate outside the office of California Gov. Gavin Newsom in Sacramento, Calif., in Sept. 2019.
Rich Pedroncelli/AP
States How Vaccine Loopholes Could Weaken COVID Shot Mandates for Kids
Evie Blad, September 28, 2021
9 min read
Diego Cervantes, 16, gets a shot of the Pfizer COVID-19 vaccine at the First Baptist Church of Pasadena on May 14, 2021, in Pasadena, Calif.
Diego Cervantes, 16, gets a shot of the Pfizer vaccine at the First Baptist Church of Pasadena last spring in Pasadena, Calif.
Marcio Jose Sanchez/AP

Lessons From History

In this April 1955 file photo, first and second-graders at St. Vibiana's school are inoculated against polio with the Salk vaccine in Los Angeles. Tens of millions of today's older Americans lived through the polio epidemic, their childhood summers dominated by concern about the virus. Some parents banned their kids from public swimming pools and neighborhood playgrounds and avoided large gatherings. Some of those from the polio era are sharing their memories with today's youngsters as a lesson of hope for the battle against COVID-19. Soon after polio vaccines became widely available, U.S. cases and death tolls plummeted to hundreds a year, then dozens in the 1960s, and to U.S. eradication in 1979.
In this April 1955 file photo, 1st and 2nd graders are inoculated against polio with the Salk vaccine in Los Angeles.
AP

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