The COVID Shot for Babies

Pregnancy

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 may happen this spring.

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 companies Pfizer and BioNTech previously announced that they will seek an emergency use authorization (EUA) for their COVID-19 vaccine for children under age 5 once they have enough data on a three-dose vaccination series.

They expect to obtain results this month, after which the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will evaluate the data before giving their go-ahead, which can take a few weeks. Moderna also plans to seek FDA authorization for a pediatric version of its COVID-19 vaccine — targeted for children between 6 months and 6 years old — in the coming weeks.

In other words, this version of the pediatric COVID-19 vaccine may become available to babies, toddlers and preschoolers later this spring.

COVID-19 cases in children surged this winter in the U.S. Data from the American Academy of Pediatrics (AAP) shows that pediatric cases reached record levels in January 2022, in large part due to the rapid spread of the Omicron variant among kids and their families.

In fact, since the pandemic began, more than 12 million children have tested positive for COVID-19 in the U.S., according to the AAP. 

Pfizer and BioNTech had previously considered submitting a two-dose series of the vaccine for an EUA as a stop-gap measure, but changed course as data for a three-dose regimen (which is thought to be more effective) accumulated much faster than expected due to the Omicron surge.

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.

A recent study published in the New England Journal of Medicine found that kids ages 12 to 18 who had received two shots of the vaccine were about 40 percent less likely to be hospitalized with the Omicron variant than their unvaccinated peers. The difference was even greater for children ages 5 to 11: Those who had gotten the Pfizer vaccine were 68 percent less likely to be hospitalized.

“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.

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 6,800 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.

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 previously announced that data on the three-dose regimen of the vaccine is expected in early April and will be submitted to the FDA when it’s available.

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 a dose of the COVID-19 vaccine include:

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.” 

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