On June 17, 2022, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines for kids under 5 years old. For many, it’s been long awaited—but parents still have questions and concerns. We reached out to pediatric experts to answer the top questions parents have about the COVID vaccine for babies, toddlers and preschoolers.

How Many Kids Under 5 Years Have Tested Positive for COVID-19?

According to Preeti Parikh, MD, a New York City pediatrician and executive medical director at GoodRx, the rates of transmission for this age group have been high, especially since it’s hard to get young kids to wear masks, socially distance and practice good hygiene. However, Amin notes the level of risk depends on a parent’s definition of risk.

In looking at the number of positive cases and the number of hospitalizations, the hospitalization rate only equates to 0.8 percent, Amin says, so the risk of hospitalization and fatality from COVID is low. However, she points out that over two million children have still tested positive. Plus, in addition to COVID, she notes a small subsect of children have developed other conditions afterwards, such as pneumonia and ear infections.

Multisystem inflammatory syndrome in children (MIS-C) is another potential complication of COVID in kids. According to the CDC, MIS-C can lead to inflammation in various organs and body parts and typically requires treatment in a hospital. To date, there have been just over 8,500 cases of MIS-C and 69 fatalities related to MIS-C, the CDC reports.

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What Treatment Is Currently Available for Kids Under 5 Who Have COVID-19?

Some immunotherapies have been approved to treat COVID in adults, Amin says, but that’s not the case for children. There are currently no FDA-approved treatments for COVID for kids younger than 5 years old. For MIS-C, most hospitals have treatment protocols in place, Amin adds.

How Does the COVID Vaccine for Kids Under 5 Work?

The FDA and CDC have granted emergency use authorization for the Moderna COVID vaccine for kids 6 months through 17 years old and the Pfizer-BioNTech vaccine for kids 6 months to 4 years old (the previous Pfizer vaccine had been authorized for people 5 years and older ). The vaccine from Moderna requires two doses, given one month apart. Pfizer’s vaccine calls for three doses; The first two are administered three weeks apart, and the third dose is administered at least eight weeks after the second.

How Effective is the COVID-19 Vaccine for Kids Under 5?

The FDA believes the COVID vaccines for babies, toddlers and preschoolers will be as effective as the vaccine in adults. In their trials, the experts looked at the antibody immune response triggered by the vaccine. They found the response in kids under 5 who had completed their doses to be comparable to adults who had completed their doses. The Moderna vaccine was found to be 50.6 percent effective in preventing COVID in kids 6 to 23 months old and 36.8 percent effective in kids 2 through 5 years old. According to Pfizer, its vaccine was found to be 80.3 percent effective in kids 6 months to 4 years old. “Both vaccines can prevent mild symptoms…but most importantly it prevents serious illness and hospitalization,” Parikh says. “The effectiveness should be similar to the older kids.”

Another consideration in looking at effectiveness is sample size. Both the Moderna and Pfizer trials used small sample sizes for their studies. Experts won’t know for sure how effective the COVID vaccines are for kids under 5 until more people in the age group are vaccinated.

Is the COVID-19 Vaccine Safe for Kids Under 5?

All major authorities on the subject believe the COVID vaccine to be safe for babies 6 months and up, toddlers and preschoolers. The FDA, CDC and American Academy of Pediatrics have all released statements based on the available data. All three organizations believe the vaccine is safe and will be effective at stopping the spread of COVID. “We don’t know all of the information, but what we do know is that it’s safe in trials and also in population data from children 5 and up that have been given the mRNA vaccine,” Amin adds.

What Side Effects Can Occur With the COVID-19 Vaccine for Kids Under 5?

According to Amin, Parikh and the FDA, the side effects most commonly seen after administering the COVID vaccine in kids under 5 include:

  • Fever
  • Irritability
  • Soreness, redness and swelling at the injection site
  • Lymph node swelling in the underarm (if administered in the arm) or in the groin (if administered in the thigh)
  • Loss of appetite
  • Chills
  • Muscle aches and fatigue
  • Nausea and vomiting

“These are symptoms that we see 48 hours after the vaccine, if they happen at all—not all children in the study have those side effects—and they went away on their own,” Amin adds.

The trials also report some rare side effects, including one reported case of a febrile seizure in the Moderna trial. February seizures typically occur in younger kids and are triggered by fever. However, Amin points out that 3 to 5 percent of young children get febrile seizures, regardless of whether or not they’ve received the COVID vaccine or have COVID, the flu or another illness that’s causing a fever. “It could be that the child was prone to febrile seizures…Children with COVID infection can get febrile seizures, children with the flu can get febrile seizures,” she says. “It’s definitely not something that’s super concerning, but it’s something that parents should know.”

Another rare side effect mentioned in the trials and the FDA EUA is myocarditis. This refers to the inflammation of the heart muscle and can be associated with symptoms of chest pain and irritability. The FDA notes the observed risk is highest in males aged 18 through 24 for the Moderna vaccine and males aged 12 to 17 for the Pfizer vaccine. “I’m going to be honest, myocarditis is extremely rare in children under 5,” Amin says. “We don’t believe it’s going to be something very significant in this age group.”

Should Kids Under 5 Who’ve Had COVID-19 Still Get Vaccinated?

Yes, experts recommend kids who have had COVID should still receive the vaccine, as it can help protect against future variants. While natural immunity is great, it’s not enough to protect against possibly aggressive new variants and in the long term, Amin says. “This virus can outsmart us. The vaccine can add more protection than natural immunity.”

Should My Child Get the COVID-19 Vaccine If They’re Sick?

If your child is sick, first confirm it’s not COVID by getting them tested, Amin recommends. If the test is positive, the CDC recommends waiting three months (90 days) before getting your child vaccinated. Studies have shown that waiting three months after a positive test and then getting the vaccine can boost immunity, Parikh explains.

According to Amin, babies under 6 months aren’t vaccinated against viruses like coronaviruses or the flu. This is due to a lack of studies looking at safety, as well as the possibility of some immunity carried over from a mom who’s been vaccinated or had the illness during pregnancy, she explains. “Most vaccine studies similar to the flu are done for 6 months and over, once [baby’s]

, MD, is a board-certified pediatrician at Pediatrics of New York, based in New York City, and a spokesperson for the American Academy of Pediatrics. She also serves as an assistant clinical professor of pediatrics at Mount Sinai School of Medicine and the executive medical director at GoodRx. She received her medical degree from Columbia University and Rutgers Robert Wood Johnson Medical School and completed postgraduate training at the Mount Sinai School of Medicine.

Mona Amin, DO, is a board-certified pediatrician based in Florida. She is also the host of the PedsDocTalk Podcast. She received her degree from ATSU School of Osteopathic Medicine in Arizona, and completed her pediatric residency at the Bernard and Millie Duker Children’s Hospital in Albany, New York.

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