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

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Key Takeaways

  • The Pfizer vaccine was authorized by the FDA for emergency use for children ages 12 and older. The Moderna and Johnson & Johnson COVID-19 vaccines have been authorized for people 18 and older.
  • Younger kids were excluded from the first COVID-19 vaccine clinical trials; however, Pfizer and Moderna have begun testing on children as young as 6 months old.
  • Experts hope the vaccine will be offered to children under 12 sometime early next year.

Now that the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines have been authorized by the Food and Drug Administration (FDA) for emergency use, millions of vulnerable people have received a shot. But the youngest members of our society, individuals under age 12, won’t get vaccinated for some time.

Younger children were excluded from the first COVID-19 vaccine clinical trials, as researchers wanted to determine that the vaccine was relatively safe in healthy adults before testing it in more vulnerable groups.

When Does Testing Start On Kids? 

It already has. Pfizer has begun a trial of its COVID-19 vaccine in children 6 months up to 11 years, with the hopes of being able to vaccinate younger children sometime in early 2022. Scientists will first study three different doses of the vaccine—10, 20, 30 micrograms—in 144 children. The doses will be assessed in children ages 5 to 11, 2 to 5, and then 6 months to 2 years.

Once Pfizer determines the appropriate dose, it will test the vaccine in 4,644 children, with one group receiving two doses 21 days apart and the other receiving two placebo shots of saline. Moderna has also started a pediatric study in children 6 months up to 12 years old.

Pfizer became the first COVID-19 vaccine to be approved for emergency use in children ages 12 to 15 in May 2021. And on December 10, Moderna began testing its COVID-19 vaccine in 3,000 adolescents between ages 12 and 17, with half receiving two injections and the other half receiving a placebo.  

“Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year,” said Moderna CEO Stéphane Bancel.

“We are encouraged by the interim and primary analyses of the Phase 3 COVE study in adults ages 18 and above, and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting.”

How Might the COVID-19 Vaccine Affect Kids?

We don't know yet, but it's 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."

Robert Hamilton, MD, FAAP

The side effects that are being seen with the adult vaccines include injection site pain, swelling, and redness, along with possible fever. 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.'

— Robert Hamilton, MD, FAAP

When some of these vaccines are licensed for use in much larger populations, we're bound to see more reports of side effects.

What This Means for You

It might be a while before kids are able to be vaccinated, so for now you should continue to follow COVID-19 public health guidelines by social distancing and having them wear a mask. Luckily, kids are pretty resilient to this virus, and when you get vaccinated it'll protect them too.

Keeping Your Children Safe From COVID-19

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 something 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.

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. "Wear masks any time you leave your house and even in your home if there is someone present who doesn’t live there or if someone who lives there is infected with COVID-19," Natterson says.

"Additionally, keep at least six feet of distance from others, and when you are around people who don't live in your home, meet them outside rather than inside. Wash your hands regularly, and if you are sick or have any symptoms of COVID-19, don’t gather with others and instead call your doctor."

Natterson adds that these rules apply to people of all ages—it doesn’t matter if you are a kid or an adult. "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," she says.

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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Article Sources
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  1. Pfizer. Studies in additional populations. 2021.

  2. Moderna. Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in pediatric population. Published March 16, 2021.

  3. U.S. Food & Drug Association. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. Updated May 10, 2021.

  4. Moderna. Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents. Published December 10, 2020.  

  5. Centers for Disease Control and Prevention. Multisystem inflammatory syndrome (MIS-C). Updated February 25, 2021.