More than a year after adults became eligible for the COVID-19 vaccine, federal regulators have approved the shots for kids under 5.

The Centers for Disease Control and Prevention, along with the U.S. Food and Drug Administration, found that three doses of the Pfizer vaccine – or two doses of the Moderna vaccine – are safe for children who are at least 6 months old.

This clears the way for nearly 20 million additional children to get vaccinated against COVID-19. And the vaccines will be available at thousands of sites nationwide, including doctor’s offices and pharmacies.

As Novant Health begins administering shots in the “under 5 group," established Novant Health patients should call their pediatrician’s office to see if they plan to offer it. Before calling, please check the clinic's Facebook page to see if that information is available online.

Other options include:

And while kids between the ages of 3 and 5 can get vaccinated at a pharmacy or grocery store, children under age 3 are not able to be vaccinated by a pharmacist in North Carolina. Their vaccines must be administered at a doctor's office.

Children between 6 months and 4-years-old

Becky DeCamillis, a physician assistant with Novant Health Infectious Disease Specialists in Winston-Salem, is eager to get her little one vaccinated. Her son, Jacob, is 9 months old.
Becky DeCamillis
Becky DeCamillis

"Not only did the manufacturers adjust the dose for smaller kids, their clinical trials demonstrated that thousands of kids were able to safely get the vaccine," DeCamillis said.

While vaccination may not prevent every case of COVID-19, their "real value," experts agree, is their ability to prevent serious illness, hospitalization and death.

“For parents like me, vaccination gives us peace of mind that if our kids contract the virus, it probably wouldn't result in more than a runny nose," DeCamillis said.

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The 'best tool' we have

More than 400 U.S. kids ages 4 and under have died from COVID-19, CDC data shows. The virus is also responsible for another 800 deaths in U.S. children and adolescents ages 5 to 18.

“We vaccinate for many other childhood illnesses that cause less severe disease than COVID-19, like chickenpox and hepatitis A," DeCamillis said. "This is because vaccines are unequivocally safer than getting infected with these diseases."

Even though most kids have mild cases, DeCamillis noted a risk of:

  • Severe COVID-19 disease, which can result in hospitalization or death.
  • Long COVID, also known as post-COVID conditions, with symptoms such as difficulty thinking or concentrating, chest pain, fever and difficulty breathing.
  • Multisystem inflammatory syndrome in children, referred to as MIS-C, a condition where different parts of the body – heart, lungs, brain, etc. – can become inflamed. Learn the symptoms of MIS-C here and know when to seek emergency care.

"The best way to mitigate those risks is not to get infected at all. And vaccination is certainly the best tool we have right now."

Becky DeCamillis, pictured below with her 9-month-old son, Jacob, whom she plans to get vaccinated.
Becky DeCamillis looks forward to vaccinating her 9-month-old son, Jacob.
Becky DeCamillis looks forward to vaccinating her 9-month-old son, Jacob.

Timing of COVID-19 vaccines

For parents who prefer to vaccinate their kids with Pfizer's mRNA vaccine, the first two doses are given three weeks apart, while the third is administered two months after the second.

For those who prefer Moderna, also an mRNA vaccine, the two doses are given one month apart.

Pfizer’s vaccine has a slightly lower dosage than Moderna’s, but the CDC recommends both vaccines equally.

“Even I was waiting on the safety data to be certain these shots are safe for our youngest kids,” DeCamillis said. “And after poring over the vaccine data presented to the FDA and CDC, I feel reassured.”

Parents are encouraged to speak with their pediatrician and ask questions as they weigh the decision.

Are the side effects the same for this age group?

In clinical trials, DeCamillis said the expected effects were "about the same" as they were in older children and adults.

Some kids had mild soreness or redness at the injection site, while some babies and toddlers experienced drowsiness or irritability. This would correspond to fatigue and malaise, or a general feeling of discomfort, in older children and adults.

Other trial participants developed a fever, which "was often short-lived and resolved within a few days, much like in the other groups," DeCamillis said. “It's also worth nothing that the side effects were consistent with other childhood vaccines."

Why did it take so long for this age group to become eligible?

“In short, we had to be sure these vaccines were safe for our smallest kids,” she said.

Keep in mind that traditionally, when testing a new therapeutic like a vaccine, more vulnerable groups like infants and pregnant women are not included in the initial clinical trials.

“There is some thought that we’d like to see real-world safety data before fine tuning the vaccines for babies and expectant mothers,” DeCamillis explained.

With the COVID-19 vaccines, in particular, the manufacturers had to dose-adjust for the pediatric populations, giving just a fraction of the dose that adults receive.

“When the clinical trials began, the Delta variant was most dominant, but by the time the trials were wrapping up, Omicron was more of a player," she said. "Since vaccine effectiveness had waned slightly, the FDA asked the manufacturers to submit more data to make sure the vaccines were effective.”

'Oh, happy day!'

While this process took a few months longer than expected, the DeCamillis family looks forward to regaining some sense of normalcy.

“Oh, happy day that we're finally discussing this!" she said. "The pandemic isn’t over, something perhaps felt most acutely by parents, like me, who have young children."

DeCamillis' son, Jacob, was ineligible for vaccination up to now. As she watched others return to pre-pandemic life, her family has continued to mask, avoid crowded places and indoor gatherings, and cancel "long-awaited trips" to see friends and family.

"Getting Jacob vaccinated will change all of those things for us."

Becky DeCamillis on why she's vaccinating her son.