When Will a COVID-19 Vaccine Be Approved for Use in Kids?

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Key Takeaways

  • Kids ages 12 and older are eligible for the Pfizer vaccine, and children ages 5 to 11 may soon be able to get their first shots too.
  • Children were excluded from the first COVID-19 vaccine clinical trials; however, Pfizer, Moderna, and Johnson & Johnson are performing safety testing on younger age groups.
  • Early reports from Pfizer indicate that children ages 5 to 11 tolerate its COVID-19 vaccine well and show a strong immune response.
  • Experts hope the vaccine will be increasingly available to younger children in late 2021 and early 2022.

Since COVID-19 vaccines were first authorized for use by the Food and Drug Administration (FDA) in December 2020, more than 400 million shots have been administered in the U.S. and more than 187 million Americans are fully vaccinated. Unfortunately, young children have yet to be part of that group.

Good news is coming for families though: The Pfizer vaccine is expected to be available for children as young as age 5 in late fall 2021. As vaccine scientists continue to conduct safety tests on different age groups, shots for even younger kids are expected to be rolled out toward the end of the year and into early 2022. Here is what you need to know about why children should be vaccinated and how soon your kids will be eligible.

When Can My Child Get Vaccinated? 

If your child is at least 12 years old, they can—and should—be vaccinated as soon as possible, according to both the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP). The Pfizer vaccine is available under an emergency use authorization (EUA) for kids ages 12 and older. (If your teen is at least 18 years old, they are eligible for the Moderna vaccine under an EUA, or they can receive the one-shot Johnson & Johnson vaccine.)

Early clinical trials of COVID-19 vaccines did not include children. But on October 7, 2021, Pfizer submitted a request to the FDA that its vaccine be authorized for use in kids ages 5 to 11. It cited findings from follow-up clinical trials that showed the vaccine to be safe and well-tolerated in this age group. Kids given a smaller dose of the two-shot vaccine also had a strong antibody response during trials, a sign that the vaccine effectively stimulated their immune system to defend itself against the virus.

Pfizer says it expects to report on safety data in its current studies on younger children—ages 6 months to 4 years—at the end of 2021.

Meanwhile, Moderna has launched a three-phase clinical trial in children ages 6 months to 11 years. Johnson & Johnson is currently conducting trials in kids ages 12 to 17.

How Might the COVID-19 Vaccine Affect Kids?

We don't have a clear picture of how children respond to vaccines, though reports from Pfizer are promising. According to the company, in clinical trial participants ages 5 to 11, "the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age."

It is important to remember that all vaccines have known side effects, and these are usually very mild. "The side effects that are being seen with the adult vaccines include injection site pain, swelling, and redness, along with possible fever," says pediatrician Robert Hamilton, MD, FAAP. "Because children have robust immune systems, these normally encountered side effects may be exaggerated in children, but this simply means that the vaccine is 'taking.'"

"Each vaccine comes with a package insert that lists the data about side effects, and this information is available online as well," says Cara Natterson, MD, pediatrician and author of Decoding Boys: New Science Behind the Subtle Art of Raising Sons. "Because the coronavirus vaccines currently under development are so new, there is only data reporting short-term side effects measurable over the past couple of months on study populations ranging in size from 30,000 to 40,000 people."

Keeping Your Children Safe From COVID-19

Whereas kids were far less likely to get COVID-19 earlier in the pandemic, rates have risen since the Delta variant started circulating in 2021. Since the pandemic began, children represented 16.3% of total cumulative cases in the U.S., but by October 7, children accounted for 24.8% of reported weekly COVID-19 cases.

Young children appear to be less likely to die from COVID-19 infection than adults, but studies have found that they have a higher risk of developing a condition called multisystem inflammatory syndrome in children (MIS-C). This is an inflammatory disease that can affect multiple organ systems throughout the body, including the brain, heart, and lungs. Between May 2020 and October 2021, 46 children had died from MIS-C, according to CDC data.

According to the Centers for Disease Control and Prevention (CDC), the cause of MIS-C remains unknown, but many children with the disease also had the virus that causes COVID-19 or had been around someone who was infected with COVID-19.

Until your child can get the COVID-19 vaccine, the best steps to protect them from infection are the ones we're all familiar with. The CDC recommends unvaccinated children ages 2 and older wear masks in all public indoor settings and crowded outdoor settings. Babies and toddlers who can't wear a mask should limit visits with people who are not vaccinated or whose vaccination status is unknown.

Additionally, unvaccinated people, especially, should socialize outdoors whenever possible and avoid activities that make it hard to stay 6 feet away from others, according to the CDC.

"Remember that it can be very difficult for kids to maintain distance from one another, so it’s up to parents to not put their kids in those situations when they are avoidable," says Natterson.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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9 Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Pfizer. Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years. Published September 20, 2021.

  2. Centers for Disease Control and Prevention. COVID-19 Vaccinations in the United States. Updated October 12, 2021.

  3. American Academy of Pediatrics (AAP) Committee on Infectious Diseases. COVID-19 vaccines in children and adolescentsPediatrics. 2021;148(2):e2021052336. doi:10.1542/peds.2021-052336

  4. Centers for Disease Control and Prevention. COVID-19 vaccines for children and teens. Updated August 17, 2021.

  5. U.S. National Library of Medicine. A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age. Updated October 13, 2021.

  6. U.S. National Library of Medicine. A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents. Updated October 6, 2021.

  7. American Academy of Pediatrics. Children and COVID-19: State Level Data Report. Updated October 11, 2021.

  8. Centers for Disease Control and Prevention. Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States. Updated October 4, 2021.

  9. Centers for Disease Control and Prevention. Families with vaccinated and unvaccinated members. Updated August 4, 2021.