If you’re the parent of a baby or toddler, you might be wondering whether you should get your child vaccinated against COVID-19 once the shot gets the green light for children ages 5 and younger — which is likely to happen soon, within the next month or so.

You probably have plenty of questions, as well as some concerns, about whether it's safe, necessary and even effective, just to name a few. Here's what parents of kids under 5 need to know about the COVID-19 vaccine for their little ones.

When will the COVID-19 vaccine be available for babies, toddlers and young children under 5?

Pharmaceutical company Pfizer announced this week that it has begun the process of seeking emergency use authorization (EUA) for its COVID-19 vaccine for children under age 5.

That means that it will need to be given the go-ahead by both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), which should happen within a matter of weeks.

In other words, this version of the pediatric COVID-19 vaccine could be available to babies, toddlers and preschoolers by late February or March.

The FDA had requested a "rolling submission" of the COVID-19 vaccine for children 6 months through 4 years of age "in response to the urgent public health need in this population," said Pfizer in its announcement. 

COVID-19 cases in children have surged recently in the U.S. Data from the American Academy of Pediatrics (AAP) shows that pediatric cases reached record levels in January 2022, and they still remain concerningly high, in large part thanks to the rapid spread of the Omicron variant among kids and their families.

In fact, since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., with children under 4 accounting for more than 1.6 million of those cases, according to the AAP. 

If granted EUA, the COVID vaccine for the littlest members of the population will come more than four months after it was authorized for 5- to 11-year-olds and nearly nine months after it became available for kids ages 12 to 15. 

 

"We look forward to offering its protection to our youngest children," said the AAP in a statement on Twitter, adding the group is "encouraged that we may be one step closer to a COVID vaccine for children under 5."

 

Is the COVID-19 vaccine safe for children under 5?

Though all the data has yet to be distributed among the medical community, the general consensus is that the COVID-19 vaccine for kids under 5, like the others already authorized for older children and adults, will be safe for babies and toddlers once it gets the go-ahead from the FDA and the CDC.

Previous data released by Pfizer found that a two-dose series of the vaccine had "a favorable safety profile" and "no safety concerns" in children ages 6 months to 4 years old. 

Should I vaccinate my baby or toddler against COVID-19?

Though doctors are eager to see the most up-to-date data on the COVID-19 vaccine for kids under 5, the sentiment in the pediatric medical community is that parents should vaccinate their babies and toddlers against the virus once the shot becomes available for that age group. Physicians point to the success seen with Pfizer's other COVID vaccines for older children ages 5 to 17.

"If the safety is as good as we saw in the vaccine we’ve been giving kids over 5 and antibody production is good, I don’t see why one would not recommend this vaccine for kids aged 6 months to 4," says Juan Salazar, M.D., M.P.H., F.A.A.P., a pediatric infectious disease specialist and physician in chief at Connecticut Children's Medical Center.

"These younger children have been getting a lot of COVID in the last two to three months and are still at risk. Having kids vaccinated soon would be a tremendous additional weapon against the virus,” he says.

Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York, believes the data "looked good" for children up to age 2. "Based on what we know so far, there don’t seem to be any safety signals of concern in the under-5 group," he says.

While COVID-19 is generally mild in this younger age group, experts note that it isn't always.

"It is true that in most cases, it will be a mild disease," Dr. Salazar says. "But I want to remind parents that we have seen kids in that age group who have developed severe COVID. We’ve had 7- and 8-month-old children in our hospital who have been intubated due to COVID, and we have seen some neurologic disease that’s happened as a result of COVID."

Children are also developing multisystem inflammatory syndrome in children (MIS-C), a serious condition linked to COVID-19 where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes or gastrointestinal organs. To date, more than 6,000 children in the U.S. have developed COVID-19-related MIS-C, according to CDC data, and sadly dozens have died from the condition. 

Dr. Salazar urges parents to consider this: "If you have something that can protect your children, why wouldn’t you use it? Are you willing to take the risk that they could get COVID? The vaccine can help you avoid that."

Will my baby or toddler need to get two or three doses of the COVID-19 vaccine?

The two-dose vaccine is effective at preventing COVID-19 in the 6- to 24-month-old group, according to Pfizer, but recent data indicates that it wasn’t quite the level of efficacy researchers had hoped for in the 2- to 4-year-old set. As a result, Pfizer said it is testing a third shot in this age group and hasn’t released the data from its latest clinical trials yet.

Still, the company has submitted the two-dose version of this pediatric COVID-19 vaccine for authorization to start with. A third dose may be added later to be administered to kids under 5, if evidence gathered in the trials suggests it's more effective against the virus.

There have been some questions from parents about whether it’s safe to give young children two or three doses of a vaccine. Experts note that this is nothing new when it comes to childhood immunizations. 

"This is a pretty common thing with children," says Dr. Salazar. "Many of the vaccines we give in childhood are three doses, and some are four." The pneumococcal conjugate, DTaP and rotavirus vaccines are just some examples. 

"There really are none that are single-dose in children,” he says. "You prime the immune system, tickle it again and finalize with a third dose. It’s a common technique."

Pfizer said in its latest announcement that data on three doses of the vaccine is expected "in the coming months" and will be submitted to the FDA when it’s available.

Dr. Russo says it makes sense that Pfizer would try to get an EUA for a two-dose vaccine while anticipating that 2- to 4-year-olds will need a third shot. 

"It’s all about expediency and trying to get shots in the arms of children as soon as possible," he says. The first two doses need to be spaced out anyway, he points out, so this enables children and families to start the vaccination process as Pfizer prepares an EUA request for the third. He said it remains to be seen whether a third dose will, in fact, be helpful for those in the 2- to 4-year-old age group.

Does the COVID-19 vaccine have side effects in babies and toddlers?

Mild, short-term side effects can happen with any vaccine, and there may be some younger children who have them with the COVID-19 shot too, Dr. Russo says, though plenty of kids (and adults) haven't had any noticeable ones at all. 

The short-term side effects that may occur after one or two doses of the COVID-19 vaccine include:

  • Sore arm at the injection site

  • Fever

  • Muscle aches

These typically surface within 24 to 48 hours of receiving the injection and disappear within a day or two. And remember that many kids and adults who have already been vaccinated have had no noticeable discomfort at all.

Should I worry about long-term side effects of the COVID-19 vaccine in my child?

Longer-term side effects, particularly an inflammation of the heart muscle known as myocarditis, have occured sparingly in older age groups, namely older teen boys and young men. But Dr. Russo says that these already-rare cases due to the COVID-19 vaccine happen "far less" often in younger children. They're also more common after having been infected by the COVID-19 virus itself than after getting a dose or two of the vaccine. And they typically appear between a few days and a week or two after the injection.

He also points out that it’s not possible to get MIS-C from the vaccine. The same isn't true of the COVID-19 virus.

"You can’t get MIS-C from the vaccine but, if you’re not vaccinated, you can get MIS-C," Dr. Russo says. Fertility concerns have also circulated on social media, but there is no data to support that the COVID-19 vaccines cause infertility, he explains.

More information and data about the COVID-19 vaccine for the youngest kids will be ready for distribution to experts and the community soon. But considering the very safe and effective vaccines we already have on the market, pediatricians say they will have no problem recommending that parents and caregivers get their babies, toddlers and preschoolers vaccinated against COVID.

"If you have an opportunity to fasten your child’s seat belt to help protect them in case of an accident — even though accidents are rare — why wouldn’t you?” Dr. Salazar says. "In the event that you have an accident, it can be a serious problem if you don’t. It’s the same idea with the COVID-19 vaccine."