Here's what parents should know about the COVID-19 vaccine's safety, effectiveness, and availability for kids.

The COVID-19 vaccine is now available across the country, and everyone 5 and up is eligible to get vaccinated (and possibly boosted). Those under 5 years old might not have to wait too much longer. That's because, on April 28, Moderna asked the Food and Drug Administration (FDA) to authorize two doses of its vaccine for children ages 6 months to less than 6 years old.

Here's everything you need to know about the COVID-19 vaccine and children.

COVID-19 Vaccine Timeline for Kids

The COVID vaccine timeline varies for different age groups. Here's the breakdown.

12 Years and Older

In May 2021, the Pfizer vaccine was approved for children 12 and up under emergency use authorization. It has full FDA approval for those 16 and older. The FDA and Centers for Disease Control and Prevention (CDC) also approved booster shots for everyone 12 and up at least five months after receiving their initial doses.

5-11 Years Old

In November 2021, children ages 5 to 11 got the go-ahead to receive a smaller dose of Pfizer under emergency use authorization. The approval came after recommendations from the FDA and CDC, and it's for two doses of 10 micrograms each, which is about one-third of the dose given to adults and adolescents. Certain immunocompromised children ages 5 to 11 can receive an additional dose 28 days after their second shot.

In May 2022, the FDA approved a booster shot for kids ages 5 to 11 at least five months after their primary vaccine series. The drug manufacturer points to a small study that showed a 36-fold increase in antibodies against the Omicron variant (as opposed to two doses of its vaccine). Now the CDC needs to sign off on the approval, which could happen this week.

6 Months to 5 Years Old

Moderna is seeking FDA authorization of its vaccine for children under 6 years old. The drug manufacturer says two low doses of its vaccine (25 micrograms each) triggered an antibody response, based on trial data from 6,700 children. Efficacy was 51 percent for those under 2 years old, and 37 percent for those between 2 and 6 years old. These numbers are lower than many parents hoped for, thanks to the transmissible Omicron variant, but the vaccine still provides much-needed protection against severe illness, hospitalization, and death.

And what about Pfizer? On February 1, Pfizer asked the FDA to authorize two doses of its coronavirus vaccine for kids under 5, as the company researched whether a third shot would make it even more effective. This followed news from late December 2021 when Pfizer announced that two doses of the pediatric vaccine didn't trigger a sufficient immune response in children ages 2 to 4 years old, according to The Washington Post. (Children 6 months to 2 years old had adequate immunity.) However, on February 11, Pfizer put a pause on seeking FDA approval for the two-dose series; the drug manufacturer decided to wait for data from the three-dose clinical trials instead. Results from these trials are expected soon.

parents with little girl getting vaccinated, everyone wearing face masks
Credit: Getty Images

Is the COVID-19 Vaccine Safe for Kids?

When clinical trials first began, children were largely excluded, which is why some haven't received COVID-19 vaccine approval yet. The exclusion was partly for ethical reasons because kids can't fully comprehend and consent to the trials. Also, children have different bodies and immune systems than adults, so experts wanted to understand safety risks thoroughly before starting pediatric testing, says Christine Turley, M.D., Pediatrics Specialist and vice chair of research at Atrium Health Levine Children's.

Once experts learned more about the COVID-19 vaccine, pediatric clinical trials began for children 6 months and up. Pfizer and Moderna are conducting trials for vaccine use in children from 6 months to 4 years old, the American Hospital Association reports.

Researchers haven't seen any red flags in clinical trials as they thoroughly evaluated the dosage, side effects, frequency, and other important elements. Experts understand that children have different immune systems and body functions than adults, and they only approve a pediatric vaccine if they're absolutely sure of its safety.

Indeed, Pfizer's pediatric vaccine involves a lower dose than what's given to adults and adolescents; experts came up with the dosage based on early trials that assessed safety. According to The New York Times, kids between 5 to 11 years old are given two doses of 10 micrograms each, which is about one-third of the dose given to adults and adolescents. Children under 5 years were initially given two doses, each with 3 micrograms, in clinical trials. Now they will be given a third dose in hopes of increasing immune response. A November 2021 study in the New England Journal of Medicine found that two 10 microgram doses of the Pfizer vaccine 21 days apart was safe and effective.

Still, some parents worry about the rapid development of the COVID-19 vaccines, since they received approval in record time. But Dr. Turley stresses that all safety procedures have been properly followed in the clinical trials, and only the administrative components have been sped up. "The FDA worked closely with vaccine experts to study a vaccine design for COVID-19," she says. "Trial design usually takes a long time, which contributes to a long time for vaccine approval, but this was all discussed before we even had a candidate."

When COVID-19 vaccines receive FDA approval for kids, you shouldn't fear getting one, stresses Purvi Parikh, M.D., an allergist and immunologist with the Allergy and Asthma Network and co-investigator on the vaccine trials. "Do not be fearful of the vaccine if you are recommended to get it, as risk of infection may outweigh any risks from the vaccine," she says. Widespread vaccination will help stop COVID-19 in its tracks, letting everyone get back to life as we knew it. 

That said, here's something to note: The CDC confirmed some cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of heart's outer lining) in people 30 and younger who received Pfizer or Moderna vaccines. Symptoms occur mostly in males after the second dose, and they include chest pain, heart palpitations, and shortness of breath. They tend to occur within a week of getting the injection. Most cases resolve with treatment. While myocarditis after vaccination remains a very rare event, medical organizations are further studying a link to the mRNA vaccines in young people. The CDC still recommends that everyone 5 years of age and older get vaccinated.

Is the COVID-19 Vaccine Effective?

Experts are still studying the COVID-19 vaccine effectiveness in kids and adolescents. One study, published March 2022 in The New England Journal of Medicine, analyzed data during the Omicron surge. For those ages 12 to 18 years, researchers found vaccine effectiveness was 40 percent against COVID-19 hospitalization, 79 percent against critical illness, and 20 percent against noncritical illness. For younger children ages 5 to 11, the effectiveness against hospitalization was 68 percent. These numbers reflect a decrease in protection over the past several months—possibly because of the lower dose of the pediatric vaccines, the emergency of more transmissible variants, and longer durations of time since vaccination.

Booster shots have been approved for kids ages 12 and up, at least five months after their primary vaccine series. This should help protect against waning immune response over time. And certain immunocompromised kids ages 5 to 11 can also get a third dose of the vaccine 28 days after their second shot.

Even though Pfizer clinical trial results weren't satisfactory for children under 5 years old, experts are working to make a safe, effective vaccine for this younger age group. As of now, this might involve including a third low-dose shot in the vaccine series, but we need to wait for clinical trial results to learn more. That said, Moderna's vaccine is shown to prevent severe illness and hospitalization in this age group.

Should My Child Get the COVID-19 Vaccine?

Parents can weigh the pros and cons of the vaccine, but experts stress the importance of getting it when your kids are eligible. Kids generally have been spared from the worst of the coronavirus, but about 19 percent of COVID-19 cases are in pediatric patients, according to the American Academy of Pediatrics. Some kids have died from the virus, and others have gotten a mysterious and deadly illness called multisystem inflammatory syndrome in children (MIS-C)

A June 2021 study published by the CDC showed that the hospitalization rate for adolescents with COVID-19 was 2.5 to 3 times higher than that age group's rate for the flu. "The benefits of vaccination far outweigh any risks," said Dr. Vivek Murthy, the Surgeon General of the United States, during a recent press conference. "It's easy to forget that not getting vaccinated is a choice that puts our kids at higher risk of getting COVID."

What's more, children can easily pass COVID-19 to parents, grandparents, and those with underlying health issues who might suffer more severe consequences. "We can't get community immunity until we know that known carriers are protected," says Dr. Turley. If majority of the population does not get vaccinated, "it will be harder to stop the spread of COVID-19" in America, adds Dr. Parikh.

For the same reason, caregivers and relatives of children should consider getting the vaccine. "If your child goes to school, parents and grandparents should take the vaccine to protect themselves, especially if you fall into one of those high-risk groups," says Dr. Parikh. "We know children can transmit the infection asymptomatically." 

Finally, Dr. Murthy recently stressed that vaccination opens up activities with friends and at school that have been severely curtailed, from "sleep overs, and birthday parties to school plays and soccer games." He adds: "Ultimately the vaccine is a pathway to getting back to the rich parts of life that bring our kids joy and fulfillment."