Pfizer says its COVID-19 vaccine is safe and effective for children between the ages of 5 and 11, based on trial data collected from over 2,200 kids.
Dr. Anthony Fauci said this week that kids “will certainly be [eligible for the approved vaccines] this fall.”
The U.S. Food and Drug Administration (FDA) previously expanded the use of Pfizer’s COVID-19 vaccine to children between ages 12 and 15 in May.
Two-thirds of all eligible Americans have received at least one dose of the three available COVID-19 vaccines, according to the Centers for Disease Control and Prevention (CDC)—a big milestone in the fight to end the coronavirus pandemic. But there’s still a major population that still hasn’t been vaccinated: children under age 12.
Now, kids as young as preschoolers could be next in line for their shots. On September 20, Pfizer and BioNTech shared that their two-dose, mRNA-based vaccine is safe and effective for children between the ages of 5 and 11; in a trial among over 2,200 kids, the vaccine was demonstrated to be “safe” and “well-tolerated,” and it “showed robust neutralizing antibody responses,” per a press release.
The U.S. Food and Drug Administration previously expanded its emergency use authorization of Pfizer’s COVID-19 vaccine for children as young as 12 in May. The vaccine, now marketed as Comirnaty, received full FDA approval for people 16 and older last month. The Moderna and Johnson & Johnson vaccines are currently available for those 18 and up, since researchers are still awaiting the results of clinical trials in young people.
While the FDA reviews Pfizer’s trial data, vaccinations for older kids will continue, bringing the country one step closer to herd immunity. But as cases explode among school-age people, when can younger children expect to be eligible for the COVID-19 vaccines? Here, doctors explain when kids under age 12 may be able to be vaccinated, plus why it’s crucial they get their jabs, too.
Why have children been excluded from receiving the COVID-19 vaccines?
Adults were prioritized in clinical trials of the COVID-19 vaccines because they were the most susceptible to severe illness, says Adam Keating, M.D., a pediatrician at Cleveland Clinic in Wooster, OH. But now that the vaccines have become widely available, children are next in line—just in time to address a massive increase in SARS-CoV-2 cases among kids.
Young people are distinct enough from adults to warrant separate studies: They’re smaller and lighter, which impacts dose size. And because they’re still growing, their immune systems operate differently at each stage of childhood, says Allison Messina, M.D., chairman of the Division of Infectious Disease at Johns Hopkins All Children’s Hospital.
“The older a child gets, the more their bodies are going to behave like a young adult,” Dr. Messina explains. That’s why older children, ages 12 and up, were the second group to be cleared for vaccinations.
Now, the next group studied and approved will likely be school-age children, from about 5 to 11 years old. Younger kids will require even more research, meaning they’ll probably be the last to receive approval.
When will kids be able to get COVID-19 vaccines?
The Pfizer and BioNTech announcement doesn’t mean that kids as young as 5 are eligible for the COVID-19 vaccine; instead, the companies are submitting their data to the FDA, which will then decide whether or not to approve it. (For reference, Pfizer announced the results of its clinical trial among adolescents on March 31; the FDA authorized Comirnaty for kids 12 to 15 on May 10.)
“It will certainly be this fall,” Anthony Fauci, M.D., the nation’s leading infectious disease expert, told ABC News this week. He expects Moderna to follow behind Pfizer by just a few weeks, meaning that both vaccines could be submitted for FDA approval among 5- to 11-year-olds by “the end of October” or early November.
Per the latest trial results, the Pfizer vaccine is remarkably effective among younger children. The pharmaceutical company’s trial included 2,268 people between the ages of 5 and 11; two-thirds of them received two doses of the mRNA vaccine spaced three weeks apart, while one-third received a placebo. Children who received a 10-microgram dose of the vaccine (a fraction of the 30-microgram dose administered in those 12 and older) had a similar immune response to participants in an earlier trial among people between 16 and 25. Side effects included fever, chills, headache, and injection site pain, identical to those reported in adults.
In other words, the trial looks like a success—and proof that safe vaccinations against COVID-19 can soon begin among school-age children. Pfizer plans to seek vaccine authorization for children ages 2 to 5 and six months to 2 years by the end of the year.
Moderna, meanwhile, announced in May that its vaccine is 96% effective in people aged 12 to 17; the company is currently seeking FDA approval for this age group, and clinical trials with kids as young as six months are underway. (Its two-dose mRNA vaccine was approved for adolescents in Canada last month.) Johnson & Johnson has expanded its trials to adolescents age 12 to 17, with plans to study younger kids in the future.
Why should children receive the COVID-19 vaccines?
Children are less likely to get seriously sick from COVID-19, per the CDC—but that doesn’t mean they’re immune. SARS-CoV-2 cases have been skyrocketing among children, especially in the South, per the American Academy of Pediatrics (AAP), as schools reopen. More than a quarter of new infections in the United States were among children during the week of September 2, the AAP reports; a year ago, they only accounted for 10%. At least 460 children have died from the novel coronavirus, according to the AAP.
“Most of the time, this is not a severe disease for kids; some of the time, it is a devastating disease, and you don’t want that to be your child,” Dr. Messina says. “It doesn’t matter how rare a disease it is—when your child has it, it’s not rare anymore.”
Dr. Keating stresses that the vaccines have been proven to be trustworthy and effective. “It’s important to tell parents that while the vaccine approval happened fast, it wasn’t rushed,” he explains.
Getting kids vaccinated is also crucial to establishing widespread immunity, both experts emphasize. The vaccines are not 100% effective, and even if most adults receive it, unvaccinated kids might still spread COVID-19 to their peers, parents, and anyone else they meet—especially with the rise of highly transmissible variants like Delta. The virus requires susceptible hosts to spread, and if more and more people are fully vaccinated, it won’t have anywhere left to go.
This article is accurate as of press time. However, as the COVID-19 pandemic rapidly evolves and the scientific community’s understanding of the novel coronavirus develops, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed on the latest news. Always talk to your doctor for professional medical advice.
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