When Can Kids Get the COVID-19 Vaccine? FDA Now Recommends Boosters for Children 12 to 15
The FDA has approved booster doses of Pfizer’s COVID-19 vaccine for 12- to 15-year-olds; until this week, they were only available to those 16 and up.
In November, the CDC added children between the ages of 5 and 11 to the groups of people who can receive Pfizer-BioNTech’s two-dose COVID-19 vaccine.
Pfizer released trial data last month showing that its vaccine provides adequate protection for 6- to 24-month-olds, but not in kids between 2 and 4 years old.
The Food and Drug Administration (FDA) approved booster doses of the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 12 and 15 this week. In the same announcement, it also allowed for a third primary series dose of Pfizer’s vaccine for immunocompromised 5- to 11-year-olds.
Amid the rise of the Omicron variant—and growing evidence that additional vaccine doses provide more robust protection against the strain than two doses of the mRNA vaccines alone—this decision expands use of the Pfizer boosters to those under 16 for the first time. (Moderna and Johnson & Johnson boosters are approved for people 18 and up; mRNA options Pfizer and Moderna and recommended over the adenovector Johnson & Johnson.)
Kids as young as 5 have been eligible to receive Pfizer’s COVID-19 vaccine since early November, when the Centers for Disease Control and Prevention (CDC) and FDA updated their guidelines. But there’s still a big question mark in the ongoing vaccination effort: children under 5, who make up about 6% of the population.
This cohort might have to wait longer, according to a December 17 announcement from Pfizer and BioNTech. Trial data showed that despite demonstrating adequate protection in the 6- to 24-month-old population, the Pfizer COVID-19 vaccine did not perform as expected in 2- to 4-year-olds. No safety concerns were identified. Now, the companies will “amend” the clinical trials to add a third dose, hoping that might prompt a more robust immune response.
In November, the CDC and the FDA accepted Pfizer’s trial data among 5- to 11-year-olds, which showed “robust” protection against the SARS-CoV-2 virus in kids, clearing the way for emergency use authorization of the two-dose mRNA vaccine for all Americans aged 5 years and up. The FDA previously expanded its emergency use authorization of Pfizer’s COVID-19 vaccine for children as young as 12 last May. The vaccine, now marketed as Comirnaty, received full FDA approval for people 16 and older in August.
So, when will younger children be able to receive their COVID-19 vaccines? Which kids should receive boosters? And will Moderna and Johnson & Johnson eventually be approved for young people, too? Here, doctors explain when kids under age 5 can expect to be vaccinated, plus why it’s crucial children of all ages roll up their sleeves.
Why did it take so long for children to be approved for the COVID-19 vaccine?
Following CDC and FDA authorization, Pfizer vaccinations are underway among children from 5 to 17; 12- to 15-year-olds can now also receive booster doses once five months have passed since their initial vaccine series. Those 5 to 11 receive 10 micrograms of the Pfizer COVID-19 vaccine, one-third the dose that adolescents and adults get; in its ongoing studies, Pfizer has administered 6 micrograms to those 6 months to 4 years old.
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, followed by 5- to 11-year-olds. Younger kids will require even more research, meaning they’ll be the last to receive approval.
Is Pfizer’s COVID-19 vaccine safe for children?
The Pfizer vaccine is remarkably effective among children 5 to 11 years old. The 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. Those who received a 10-microgram dose of the vaccine had a strong immune response. Side effects included fever, chills, headache, and injection site pain, identical to those reported in adults.
Despite that trial’s success, Pfizer’s latest trial among even younger children had mixed results; although the vaccine was successful in children between 6 and 24 months, it didn’t spur the expected response in those between 2 and 4. The company is now testing a third dose among those age groups, along with 5- to 12-year-olds and will seek authorization in the first half of 2022 if the results are positive, per its recent announcement. (Three doses appear to be successful at fending off the Omicron variant in adults, although it’s unclear if this will also be the case in kids.)
In its latest announcement, the FDA revealed no new safety concerns following a booster dose among 12- to 15-year-olds. Zero new cases of the very rare complications myocarditis and pericarditis were reported among trial participants.
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 in August.) Johnson & Johnson has expanded its trials to adolescents ages 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. Kids made up 17.4% of new SARS-CoV-2 infections in the United States the week of December 9, per the American Academy of Pediatrics (AAP). At least 735 children have died from the novel coronavirus, according to the AAP. And amid Omicron’s spread, pediatric COVID-19 cases are skyrocketing.
Some children require hospitalization and intubation, just like adults, and many who have recovered deal with chronic COVID, per a 2020 analysis; those long COVID symptoms can be debilitating.
“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 Omicron and 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.
You Might Also Like
