CDC and FDA Formally Recommend Pfizer’s COVID-19 Vaccine for Kids 5-11. What Happens Now?
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The CDC has formally recommended the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years old, a major step toward herd immunity.
Following last week’s FDA approval, all Americans 5 and older are now eligible to receive at least one type of COVID-19 vaccine.
Children in this age group will receive a one-third dose of the mRNA vaccine split across two doses, administered three weeks apart.
The Centers for Disease Control and Prevention (CDC) formally recommended Pfizer-BioNTech’s COVID-19 vaccine for children 5 to 11 years old late last night, clearing the way for pediatric vaccinations to begin as soon as today. This follows the U.S. Food and Drug Administration’s (FDA) approval, which was announced on October 29.
CDC director Rochelle Walensky issued the recommendation hours after an influential CDC advisory panel recommended Pfizer’s vaccine for this age group, which represents about 28 million Americans, a major moment in the fight against the novel coronavirus.
“While we hope to see the first set of kids start to get vaccinated at the end of [this] week, the bulk of vaccines will be in their locations by the week of November 8,” Jeff Zients, the White House's COVID-19 response coordinator, told NPR last week. “Between now and then, the program will be ramping up to its full strength.”
Children 5 to 11 will be given a one-third dose of the mRNA vaccine, administered three weeks apart. Now, only kids 4 and younger will be ineligible for the COVID-19 vaccines in the United States—a big win for families.
“This is going to be extraordinarily helpful, and will no doubt be a relief for many parents,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York. “Some families will finally be able to be fully vaccinated.” So far, only a third of all Americans have been vaccinated against SARS-CoV-2, the virus that causes COVID-19, according to the CDC. That number will soon grow—and not a moment too soon.
Currently, a quarter of new COVID-19 cases are among children, according to the American Academy of Pediatrics (AAP), and over 100,000 new cases were reported among children just last week. CDC and FDA approval hasn’t come a moment too soon—here’s everything you need to know about the Pfizer-BioNTech COVID-19 vaccine for children.
How effective is Pfizer’s COVID-19 vaccine in children?
The data submitted for the Pfizer-BioNTech vaccine analyzed information from about 2,250 study participants aged 5 to 11. About 1,500 received the vaccine, while 750 got a placebo. The children who received the vaccine were given a 10 microgram dose of the mRNA vaccine, and were vaccinated again three weeks later.
Researchers found that the vaccine was 90.7% effective at preventing COVID-19 infection. There were no cases of severe COVID-19 reported, and no study participants developed multi-system inflammatory syndrome (MIS-C), a rare inflammatory condition tied to COVID-19.
Is it safe to vaccinate children 5 to 11 years old against COVID-19?
While plenty of parents are excited to get their kids vaccinated against COVID-19, research has shown that a solid portion are hesitant to give the shot to their kids. But despite the concern, the data is clear: The vaccine has more benefits than drawbacks right now—even if children are less likely to experience severe illness.
It will take some time to see drops in COVID-19 cases once the vaccine becomes available for children in this age group, Dr. Russo says. “Even if we vaccinate every single child, there’s going to be a lag because there needs to be two shots,” he says. However, he notes that school-age children may be protected in time for the holidays and will head back to school with an added layer of protection from COVID-19.
Overall, having more people in the United States be eligible to be vaccinated “will increase the overall level of immunity in the population,” says infectious disease expert Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security. As a result, he says, COVID-19 cases will continue to drop.
This can be location-specific, though. “Vermont, which has a very high vaccination rate, is going to be different from Utah, which has one of the worst in the country,” Dr. Russo says.
What should parents know before vaccinating this age group?
Many parents are focused on the risk of myocarditis, an inflammation of heart muscles, which is a rare complication of the COVID-19 vaccine that has shown up in some older populations. The data submitted for the Pfizer-BioNTech vaccine for 5-to-11-year-olds did not observe any myocarditis cases during the vaccination period or during a three-month follow-up. However, Dr. Russo says, that doesn’t mean it won’t show up as more children get the shot.
Still, “myocarditis does not appear to be something that is a major risk in this group,” Dr. Adalja says. The risk of myocarditis is also “much greater” when someone actually contracts COVID-19, Dr. Russo points out.
Overall, the risk of myocarditis is “outweighed by the benefit of the vaccine,” Dr. Adalja says especially with such rampant spread right now. The vaccine can also help protect children from long-haul COVID symptoms that doctors are still learning more about, Dr. Russo explains. “Long COVID can be quite disabling,” he warns. “I’ve been extraordinarily concerned about long-term consequences to the brain, heart, lungs, and other organs.”
When will Moderna and Johnson & Johnson vaccines become available to kids?
Moderna shared interim data from its COVID-19 vaccine trial in 6-to-11-year-olds that found the vaccine delivered a “robust” antibody response and “favorable” safety profile. However, Moderna has not yet submitted its data to the FDA for an emergency use authorization. Johnson & Johnson is also still investigating its COVID-19 vaccine in kids—but there is no guarantee that either vaccine will receive emergency use authorization.
How will the vaccines be distributed?
“We have already secured enough vaccine supply for every child in America, and over the past weekend, we began the process of packing and shipping out millions of pediatric vaccine doses,” President Joe Biden said in a statement last night. “These doses—specially designed for these younger children—have started to arrive at thousands of locations across the country.”
The Biden Administration previously announced that there are enough doses to vaccinate 28 million children, and doctor’s offices, pharmacies, and schools will get them. More than 25,000 pediatric and primary care provider sites will provide vaccinations for children, the administration says, along with tens of thousands of other provider locations like pharmacies and children’s hospitals.
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