The Pfizer COVID-19 Vaccine Has Been Approved For Kids Under 5

Pfizer’s vaccines for children under the age of 5 have been approved. On June 17th, the FDA authorized the vaccine for emergency use authorization (EUA), and on June 18th, the CDC—along with CDC director Rochelle Walensky—recommended the vaccines, which means that children can now begin receiving it.

This is a major milestone for parents who have been anxiously awaiting a COVID-19 vaccine for their young children. Both teens aged 12 to 15 and children aged 5 to 11 have had COVID-19 vaccines available to them since 2021. 

But parents of young children haven’t been able to live with the reassurance that their children will be protected from severe infection from COVID-19. This was particularly concerning during the Omicron surge of late 2021 and early 2022, when unvaccinated children were hospitalized at record numbers.

Still, even as many parents will likely feel relief at the news of a vaccine available to their young children, other parents may feel concerned about giving their child the vaccine. Here's what to know the significance of the vaccine’s approval, what the trial data showed, and what to do if you have any concerns about giving your children the vaccine.

What the COVID-19 Vaccine Approval Means for Parents

It's reassuring that COVID-19 is generally mild for children, but serious outcomes are possible. A COVID-19 vaccine for babies and young children offers protection against severe disease and the most critical outcomes of a COVID-19 infection.

There continues to be data released about the poor outcomes that unvaccinated young children can experience with COVID-19, especially in light of the Omicron variant and sub-variants. According to the CDC, during the Omicron surge that spanned December 2021 to February 2022, children aged 0 to 4 years old were hospitalized at five times the rate that they were during previous COVID-19 surges, including the Delta surge.

A vaccine for babies and young kids under the age of 5 protects from infections and hospitalization, as well as from the longer-term effects of COVID-19 infection, says J. Wes Ulm, MD, PhD, physician, medical researcher, and expert in infectious diseases. Dr. Ulm cites the recent data linking COVID-19 infections in kids to diabetes, as well as other complications.

“Many children have wound up in pediatric ICUs, while others are battling a rare but dreaded complication called MIS-C (multi-system inflammatory syndrome in children) or facing longer-term organ damage,” says Dr. Ulm. “For these reasons, in particular, there is growing interest in a safe, effective vaccine regimen for young children.”

It’s not just about the protection for your child, though, but also the protection of other members of your household and your community.

“Even for families that are otherwise fully vaccinated and boosted, taking precautions with masking and social distancing, there is still the unsettling potential for young kids to be infected by SARS-CoV-2 (the virus causing COVID-19), or asymptomatic carriers who can then spread it to others in the household,” Dr. Ulm explained. “A working COVID-19 vaccine for children under 5 would help to address this issue."

What the Vaccine Trial Data Showed

According to Pfizer, the vaccine was tested in a group of 1,678 children aged 6 months through 4 years. Children were given a 3 µg dose of the Pfizer vaccine in two separate doses. Then, two months after the second dose, children were given a third dose of the 3 µg vaccine.

The dose given to young children is smaller than the dose given to 5 to 11-year-olds (10 µg) and the dose given to 12 to 15-year-olds (30 µg). This three-dose routine was found to produce a strong immune response in children, similar to the immune response produced in 16 to 25-year-olds.

According to the FDA, Pfizer's three-shot vaccine was about 80% effective at preventing COVID-19 infections among study participants. However, this is early data and based on a limited number of cases, so this figure may change.

Potential Side Effects

There were no safety concerns found for the children receiving the vaccine, Pfizer reports. The vaccine was described as “well tolerated” in this age group, and any adverse events were described as “mild” or “moderate.”

The most common side effect reported to the FDA was pain at the injection site and fatigue. Fever was less common than these two side effects, and occurred 5% of the time.

How and Where Children Can Get the Vaccine

As was the case with the vaccines for other children, Dr. Ulm expects the vaccines for young children to be widely available. “In part due to the sheer scale of COVID-19 vaccination and to the ongoing public health emergency it entails, efforts have already been undertaken to make the vaccines as widely available as possible for children and teenagers, and the same would likely apply to a COVID-19 shot for under-5 children,” he explains.

Zachary Hoy, MD, a pediatric infectious disease specialist at Nashville Pediatric Infectious Disease in Tennessee also expects a similar rollout. “I would expect it to be available first at pediatrician offices and health departments, and then expand to pharmacies,” Dr. Hoy suggests.

If You Are Having Concerns About the Vaccine

Parents may have various apprehensions about giving their children the COVID-19 vaccine, from concerns about the vaccine being new, to the idea that children don’t usually suffer severely from COVID-19.

“Parents are right to proceed cautiously and gather as much information as possible, given their kids’ growing bodies,” says Dr. Ulm. However, he believes parents can trust that the vaccines were carefully studied before being approved. “I would tell families that the vaccines are being vetted under rigorous conditions of assessment and evaluation, and must meet stringent criteria for approval."

As for the idea that children don’t usually get that sick, and therefore don’t need to be vaccinated, Preeti Parikh, MD, pediatrician and executive medical director at GoodRx, points to the recent surge in cases to argue otherwise.

“In January 2022, we saw over 3.5 million child cases reported with COVID-19—just for January alone," says Dr. Parikh. Additionally, she says, we don’t know the long-term effects of COVID-19 on children, and although most cases are mild, some children do indeed get very sick and require hospitalization.

“If there is a way to help prevent our children from getting severe illness and hospitalization with a safe and effective vaccine, I hope we can provide that protection for our children,” Dr. Parikh commented.