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COVID-19 vaccine for kids under 5: What parents need to know about safety, efficacy

The first shots started going into small arms this week.
/ Source: TODAY

The youngest Americans can now receive the COVID-19 vaccine after the Centers for Disease Control and Prevention recommended both Moderna's and Pfizer's vaccines for infants, toddlers and small children.

CDC Director Rochelle Walensky signed off on an advisory committee's endorsement on Saturday, a day after the U.S. Food and Drug Administration authorized emergency use, clearing the way for the shots to become available this week.

The first children under 5 started getting the vaccines on Monday. Distribution has started across the country, with the shots available at pediatric practices, pharmacies, clinics and other locations, the CDC said.

Parents can reach out to their doctor, local pharmacy or health department, or visit to see where vaccines for children are available. 

Kids younger than 5 — about 18 million in all — were the last age group in the U.S. to become eligible for the shots.

"We are reaching another major milestone in our efforts to protect more children, their families, and our communities as we work to end the pandemic," said Health and Human Services Secretary Xavier Becerra in a statement.

"Based on CDC and FDA actions, we now know that vaccination for our children 6 months through 5 years old is safe and effective and we are ready to get millions of children vaccinated."

Some 10 million doses of the vaccine were ready to go this week, with millions more to come in the next weeks, the White House said.

What should families know as the shots become available?

TODAY asked Dr. Kristin Moffitt, a physician scientist in the pediatric infectious diseases division at Boston Children’s Hospital and an assistant professor of pediatrics at Harvard Medical School; and Dr. Angela Myers, director of the infectious diseases division at Children’s Mercy Hospital in Kansas City and an assistant professor of pediatrics at the University of Kansas School of Medicine.

Does my baby, toddler or small child really need to get vaccinated?

It’s true that the majority of kids who get COVID-19 have mild symptoms or no symptoms at all — but some kids do get severe disease, Myers cautioned.

“You cannot predict if your kid is going to get severe disease or not,” she said. “Why wouldn’t you vaccinate to prevent something that could be bad?”

The virus is unpredictable, as previous waves of illness have shown. COVID-19-related hospitalizations were five times higher in young children during the first omicron surge than they had been with prior variants, Moffitt added.

“One of the biggest issues with COVID-19 throughout the pandemic is that it has surprised us time and time and time again with new variants and new surges… we just don’t know this virus,” she noted.

“A vaccine that can prevent those more serious outcomes from COVID-19 infection in children would be a game changer.”

It could also prevent younger children from infecting other family members, especially grandparents.

What are the two different vaccine options?

Both are still mRNA vaccines, but Moderna and Pfizer went two different routes when it came to their plan to vaccinate the youngest kids.

Moderna’s vaccine is a two-dose regimen for children 6 months to 5 years old, with the shots given four weeks apart. The dosage is a quarter of that given to adults. When it came to protection against infection from the omicron variant, efficacy was about 43% for children ages 6 months to 2 years; and about 37% in children ages 2 to 6, the company reported.

Pfizer’s vaccine is a three-dose regimen for children 6 months to 4 years old, with the first two shots given three weeks apart, followed by a third dose at least two months later. The dosage is one-tenth of that used for adults. The three doses were 80% percent effective against the omicron variant, the company said.

What should parents know about the efficacy?

The efficacy data needs to be interpreted “a bit cautiously” because the trials involved very small numbers of COVID-19 cases — both in children who received the vaccine and those who received the placebo, Moffitt said.

“We’ll know a lot more about the true effectiveness of these vaccines at preventing symptomatic COVID-19 infection as these vaccines roll out to larger numbers of children,” she noted.

“Protection against serious COVID-19 infection can likely be expected based on what we’re seeing (in both the Moderna and Pfizer studies), at least for antibody responses.”

Are the vaccines safe for small kids?

Parents can trust the vaccine approval process, Myers said, pointing out that it took months for the companies to submit information that satisfied government regulators.

“We have had to re-evaluate our time frame multiple times because the FDA was saying, ‘We want you to get more data. We want you to do this, we want you to do that,’” she noted.

“That is how we make sure we have the most robust science and the best data for which to make decisions on.”

The follow-up data from the trials has been “very, very reassuring,” Moffitt said, noting that the most common local side effect was pain at the injection site.

When it came to systemic side effects, headache and fatigue were the most common in the Moderna trial, while fatigue was the most common in the Pfizer trial, she added. Both vaccines were associated with very small occurrences of fever in the several days after getting the shot.

That is very similar to what doctors expect with any other vaccine for children of this age, Moffitt said.

There were no cases of myocarditis — inflammation of the heart muscle reported in some boys and young men under the age of 30 who received two doses of an mRNA coronavirus vaccine — in the trials.

Which vaccine would pediatricians choose?

Both experts said they wouldn’t have a preference between the two. Moffitt added that she hasn’t seen data that would indicate one vaccine was truly superior over the other when it came to the immune response it generated or the efficacy it showed against symptomatic infection.

The decision may just come down to practical reasons such as:

Which vaccine does my pediatrician or preferred vaccine site have available?

How quickly do I want my child to be fully immunized? The Moderna two-dose series is going to take about two months less time to complete than the Pfizer three-dose series, so if a child needs to be in a new daycare program a few weeks from now, a family may prefer the faster option.

Will I be able to return three times with my small child for the full Pfizer series? That could be a big consideration for families. It may require taking time out of work or bringing other kids along an extra time, versus two times with Moderna.

How much of a track record do I want the vaccine to have in older kids? “With the Pfizer vaccine, we have now a safety profile that’s been demonstrated in millions of 5- to 11-year-olds who’ve received the Pfizer vaccine. There is reassurance in numbers, and we don’t quite have that sort of scale of reassurance with the Moderna vaccine yet,” Moffitt noted because its candidate for children 6 to 17 years old is just now being considered by the FDA.

Bottom line:

Based on the data that’s been made available, there is no concern or reason for delay when it comes to vaccinating children younger than 5 against COVID-19, Moffitt said.

Parents want what’s best for their child, so it’s understandable that some are hesitant, Myers added.

“What I would stress is that your pediatrician also wants what’s best for your child, and they wouldn’t be recommending something that they didn’t think was safe and effective,” she said.

“So if you do have that kind of unease then please, please bring it up and give your pediatrician the opportunity to help walk you through whatever is making you uneasy so that you can then make it a really informed decision.”