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.
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.
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.
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.