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

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In October 2022, the FDA authorized the updated bivalent boosters from Pfizer and Moderna for everyone ages 5 and older. These boosters provide protection against both the Omicron variant and the original strain of the virus.

In December 2022, the FDA extended this authorization to children between 6 months and 4 years old. They can now get a booster after the Moderna primary series, or as part of the Pfizer primary series.

Key Takeaways

  • Kids ages 6 months and older are eligible for the Pfizer and Moderna vaccines under U.S. Food and Drug Administration (FDA) emergency use authorizations.
  • Studies show that children tolerate the COVID-19 vaccines well and receive a strong immune response even with a smaller dosage than given to adults.
  • Even though the earliest clinical trials of COVID vaccines were performed only on adults, Pfizer, Moderna, and Johnson & Johnson (J&J) have since carried out extensive safety testing on younger age groups and continue to research how even younger children will respond.

Since COVID-19 vaccines were first authorized for use by the Food and Drug Administration (FDA) in December 2020, more than 596 million shots have been administered in the U.S. and more than 222 million people are fully vaccinated. Fortunately, young children are now part of the growing number of protected Americans.

The Pfizer and Moderna vaccines are now available for children as young as 6 months old. Here is what you need to know about why and when children should be vaccinated.

When Can My Child Get Vaccinated? 

If your child is at least 6 months 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 and Moderna vaccines are available under emergency use authorizations (EUA) for kids ages 6 months and older. (If your teen is at least 18 years old, they also may be eligible for the one-shot Johnson & Johnson vaccine, however, due to safety and efficacy concerns with the J&J shot, the Pfizer and Moderna vaccines are preferred.)

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.

Both Pfizer and Moderna began studying their vaccines in children as young as 6 months old as well. Johnson & Johnson also began conducting trials in kids ages 12 to 17, however, the J&J vaccine is not available for children and is no longer recommended for adults except in limited circumstances, such as for those with allergies to an ingredient in the Pfizer or Moderna vaccines.

How Might the COVID-19 Vaccine Affect Kids?

Children tend to respond very well to the COVID-19 vaccines. According to Pfizer's data, 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 Robert Hamilton, MD, FAAP, a pediatrician at Pacific Ocean Pediatrics in Santa Monica, California. "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."

The best way to protect children from infection is to get them vaccinated and boosted, if eligible. Children ages 6 months and older can get the Moderna or Pfizer vaccines. For those ages 5 and up, a booster is recommended 2 months after the primary series is completed.

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 have represented 16.8% of total cases in the U.S., but during the week ending on November 11, 2021, children accounted for 27% 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 the end of October 2021, 48 children 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.

Children who have recovered from MIS-C should make sure to stay on top of their COVID vaccinations. Research published in January 2023 showed patients with a history of MIS-C had no adverse reactions to the vaccine. One caveat—if your child has had MIS-C, they should wait 90 days after diagnosis to receive the vaccine.

The CDC also 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 crowded, indoor 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 Dr. 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.

12 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. U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups.

  2. U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) COVID-19 vaccine for children down to 6 months of age.

  3. Centers for Disease Control and Prevention. COVID-19 vaccines for children and teens.

  4. Pfizer. Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years.

  5. Centers for Disease Control and Prevention. COVID-19 vaccinations in the United States.

  6. American Academy of Pediatrics (AAP) About the COVID-19 vaccine: Frequently asked questions.

  7. 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.

  8. 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.

  9. American Academy of Pediatrics. Children and COVID-19: State Level Data Report.

  10. Centers for Disease Control and Prevention. Health department-reported cases of multisystem inflammatory syndrome in children (MIS-C) in the United States.

  11. Elias MD, Truong DT, Oster ME, et al. Examination of adverse reactions after covid-19 vaccination among patients with a history of multisystem inflammatory syndrome in children. JAMA Netw Open. 2023;6(1):e2248987. doi:10.1001/jamanetworkopen.2022.48987

  12. Centers for Disease Control and Prevention. Families with vaccinated and unvaccinated members.

By Claire Gillespie
Claire Gillespie is a freelance writer specializing in mental health. She’s written for The Washington Post, Vice, Health, Women’s Health, SELF, The Huffington Post, and many more. Claire is passionate about raising awareness for mental health issues and helping people experiencing them not feel so alone.