Largest Study To Date Finds COVID-19 Vaccines For Kids 5 and Under Are Safe

Published by the American Academy of Pediatrics, this study provides parents with reassurance when they take their children to get the COVID vaccine.

Although the pandemic is in the rearview mirror for most of us, COVID-19 is still out there and continues to spread. According to the Centers for Disease Control and Prevention (CDC), COVID vaccines continue to offer the best protection against severe disease and death for all ages, including children. Yet vaccination rates for kids continue to lag well behind uptake for adults, likely due to parents’ concerns about safety.

But a new study should help put some of those concerns to rest. Just published in Pediatrics, this is the largest study to date looking at the safety of COVID-19 vaccines for kids 5 and under. What the study determined is highly encouraging, with no vaccine safety concerns found among the 245,000 vaccine doses given.

Related: How to Explain Vaccines to Children

Most Comprehensive Study on COVID Vaccine Safety For Young Kids

According to the lead author Kristin Goddard, MPH, a senior research manager at Kaiser Permanente, this is the largest, most comprehensive study so far to look at the safety of the COVID vaccines for children under 5 years old.

The study looked at both Pfizer and Moderna mRNA vaccines given between June 18, 2022, and March 18, 2023. During that timeframe, 135,005 doses of Pfizer and 112,006 doses of Moderna were given—all to kids ages 6 months to 4 years old.

The children were observed for 21 days after vaccination. Importantly, study researchers didn’t find any cases at all of myocarditis or pericarditis (both inflammatory heart conditions) following vaccination. There was one case of pulmonary embolism and one case of hemorrhagic stroke, but researchers say these were not caused by the vaccination. Both of these children had congenital abnormalities, which likely caused these reactions. There was one case of anaphylaxis (a serious allergic reaction), but this was caused by a food allergy.

The bottom line here? “The study found no evidence of safety concerns for the COVID-19 vaccine for young children, which can be very reassuring to parents,” says Goddard.

Ilan Shapiro, M.D., a pediatrician, chief health correspondent, and medical affairs officer at AltaMed Health Services, is happy to see these solid and encouraging results. “The study did not find any concerns or problems with the heart or any other health or safety issues,” he says. “This aligns with the safety data that we do have with monitory systems to reassure our parents that vaccination is a viable option to protect their kids against COVID-19, long COVID, and other complications from the infection.” 

Related: The Biggest Barriers to COVID-19 Vaccination—and How to Break Them Down

What to Do If You Still Have Concerns About COVID Vaccines

While these study results may be encouraging for some parents of little ones, others may still feel uncertain. Although both Pfizer and Moderna vaccines have been authorized for emergency use for children 5 and under since June 2022, the vaccination rates for this age group are quite low.

According to the Academy of American Pediatrics (AAP), only 13% of kids aged 6 months to 4 years have received one dose of a COVID vaccine. The numbers are higher for other age groups, with 39% of 5-to-11-year-olds having had one dose, and 32% having two doses. The rates are even higher for tweens and teens: 68% of kids aged 12-17 have received one dose and 59% have received two doses.

Dr. Shapiro says he empathizes with parents’ concerns. “As a pediatrician and father, I understand the importance of having the best outcomes for our kids,” he shares. “As parents, we are faced with difficult choices, and when we don't have information, we feel like pausing the process, which has been happening with the COVID-19 vaccination.”

New research like this can be helpful information for parents as they make health decisions for their kids. For many parents, a large study like this will help them feel more comfortable moving forward with vaccination, Dr. Shapiro says.

“Initially, we didn't have enough information, but we knew the COVID-19 vaccination was safe,” Dr. Shapiro says. “After thousands of children have been vaccinated and protected, we have seen the difference this vaccine can make when administered.”

Zachary Hoy, M.D., a board-certified pediatric infectious disease specialist at Pediatrix Medical Group in Nashville, Tennessee, encourages parents to get in touch with their child's pediatrician if they have any lingering questions about COVID-19 vaccine safety for kids.

“For parents who have concerns, I would encourage them to make an appointment with their child's pediatrician to discuss vaccine risks/benefits and to ask specific questions about their child to determine if the COVID vaccine is needed,” he says.

Related: Yes, You Should Get the COVID Vaccine Even If You're Trying to Get Pregnant—Here's Why

Why Is COVID Vaccination Important for This Age Group?

Part of the reason why some parents have been hesitant to vaccinate their young kids is because, thankfully, COVID is usually not as severe in children. But, as the CDC notes, just because COVID is usually less serious in children as compared to adults, that doesn’t mean it can’t have severe consequences for them. This is especially true for children who have any underlying medical conditions—though even healthy children can get very sick with COVID, as the CDC points out.

“Even though the public perception is that children don't have health complications, children who contract COVID-19 and are brought to the hospital learn they have other infections in their lungs, heart, and other systems,” Dr. Shapiro says.

COVID vaccination can prevent many of these serious complications. “Ensuring we are giving children protection can help the body respond quicker and neutralize the COVID-19 infection before it can amplify the body's inflammatory response,” Dr. Shapiro explains.

In noting just how important it is for all children over 6 months old to get vaccinated, the CDC officially added the COVID vaccine to its childhood immunization schedule in March 2023. This is a timetable the CDC updates annually and is used by health care providers to help keep your child protected against viruses and other diseases.

Related: COVID-19 Is More Severe When Kids Have Secondary Viral Infection

Should You Vaccinate Your Child If They’ve Already Had COVID?

At this point in the pandemic, many of our children have gotten COVID. The AAP estimates since May 2023, there have been reports of almost 15.6 million children testing positive for the virus. This is likely an undercount though, due to the lack of available tests during surges and the changing of how tests are reported (such as the prevalence of home tests), the AAP notes.

Many parents of already infected little ones may be wondering why COVID vaccination is necessary. One reason to get vaccinated and to keep up with the booster recommendations is because the virus is constantly mutating, and vaccines can protect you from serious illness, even if you’ve had COVID before. “Kids who have had COVID in the past are still recommended to get the COVID vaccination to help protect against other strains,” says Dr. Hoy.

Dr. Shapiro is on the same page. “COVID-19 has continued to give us many learning opportunities,” he says. The virus continues to evolve, and continues to try to dodge our bodies' defenses, he explains. “The vaccine helps our bodies mount a more robust defense line against infection.”

In fact, says Dr. Shapiro, having “hybrid immunity” (immunity from both infection and vaccination) is one of the best ways to defend a child against serious illness because it gives our immune system multiple ways to defend the body.

If you have questions about when to get a COVID vaccination after your child’s COVID infection, or if you have any further concerns about vaccinating your child against COVID, please don’t hesitate to get in touch with your child's health care provider.

Related: First At-Home Test for Both COVID-19 and Flu Now Available

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