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The agencies approved backed emergency use authorization of Moderna's a two-part vaccine for children ages 6 months through 5 years, and Pfizer-BioNTech's three-dose vaccine for children ages 6 months through 4 years.
The CDC encourages parents to vaccinate all eligible children, including those who have already had COVID-19.
"Together, with science leading the charge, we have taken another important step forward in our nation's fight against COVID-19," CDC Director Dr. Rochelle Walensky said in a June 18 statement. "We know millions of parents and caregivers are eager to get their young children vaccinated, and with today's decision, they can."
Here's what to know about COVID-19 vaccines for children, including what ages they're approved for, possible side effects and differences between the two approved vaccines.
How old do kids need to be to get a COVID vaccine?
With the CDC backing the FDA recommendations, two COVID vaccines are now approved in the US for children under 5 years old: Moderna's is for children 6 months through 5 years old, while Pfizer's vaccine is intended for kids 6 months through 4 years old.
How many vaccine shots do kids get?
Moderna's vaccine is a two-shot dose. Each dose is 25 micrograms, a quarter the strength given to adults, with the second shot given four weeks after the first.
Pfizer's vaccine is a three-shot process: Each dose is only 3 micrograms, a tenth of the adult version. The first two shots are given three weeks apart, and the third is administered at least two months after the second.
Is the COVID vaccine safe for children?
The results submitted to the FDA and CDC are still preliminary, both agencies say they are safe and effective.
"There are many processes in place to ensure safety, including oversight from vaccine advisory groups, the FDA, and the vaccine manufacturers," Dr. Leslie Sude, a pediatrician at the Yale School of Medicine, said in a statement. "We are fortunate to live in a country that has these oversights in place."
Sude added that children get lower doses of the vaccines than adults but "mount robust antibody responses with no safety concerns."
What are the side effects?
The two vaccines for younger children produced common, mild side effects including irritability, sleepiness, fever, fatigue and pain at the injection site, similar to the effects reported in a December 2021 CDC report on more than 8 million doses of Pfizer's vaccine given to kids 5 to 11.
FDA Commissioner Robert Califf said in a June 17 statement that parents of younger children "can have confidence in the safety and effectiveness of these COVID-19 vaccines and be assured that the agency was thorough in its evaluation of the data."
Inflammation of the heart muscle, known as myocarditis, is a rare and typically mild side effect linked to the Moderna and Pfizer vaccines, mostly in adolescent males and young men ages 12 to 29. (Myocarditis can also occur after infection with COVID-19.)
In one study, the CDC said that only 54 recipients out of 1 million males ages 12 to 17 experienced myocarditis following their second dose of Pfizer-BioNTech's vaccine.
Neither trial with younger children reported any cases of myocarditis, but the FDA said there isn't enough data to adequately determine the risk.
What's the difference between the Moderna and Pfizer vaccines?
There are several key differences between the two vaccines, including potential side effects and proven effectiveness.
Side effects Between 21% to26% of kids age 6 months to 5 years developed a fever after each dose of the Moderna vaccine, more than in adolescents and adults. Fever was less common in the Pfizer trial, reported in only 7% of children ages 6 to 23 months after each shot.
In the Moderna trial, 62% of kids 3 to 5 years old experienced fatigue, compared with just under 45% of children age 2 to 4 years old in Pfizer's trial.
Effectiveness Two doses of the Moderna vaccine are 51% effective in preventing infection in children 6 months to 2 years old, the company reported, and 37% in kids 2 through 5. The vaccine's ability to prevent serious illness or hospitalization is expected to be higher.
Pfizer has reported its three-dose vaccine was 80% in preventing infection, but its research was based on a very small pool of subjects. More data will become available as its vaccine is rolled out widely.
Do kids even need to be vaccinated for COVID?
Children are less likely to experience severe illness than adults, but some have become extremely sick. The omicron wave was specifically hard on children, leading to an increase in juvenile hospitalizations. Between December 2021 and February 2022, nearly 90% of children 5 to 11 who were hospitalized were unvaccinated, according to the CDC.
Of those children, 30% had no underlying medical conditions that would have made them more susceptible to more serious complications.
An April 2022 CDC report found that 75% of children age 11 and younger showed evidence of previous coronavirus infection, with roughly one-third becoming newly seropositive since December 2021. But having antibodies for the virus "should not be interpreted as protection from future infection," the agency said in a statement.
"Vaccination remains the safest strategy for preventing complications from SARS-CoV-2 infection, including hospitalization among children and adults."
Kids 5 to 11 who have COVID-19 also have a higher risk of multisystem inflammatory syndrome, or MIS-C, a rare but potentially serious complication that can involve inflammation of the heart, lungs, kidneys, brain, skin, eyes and other organs.
More than 2 million cases of COVID-19 have been reported in children 4 years old or younger in the US, according to the CDC, resulting in 442 deaths.
And even a mild case of COVID-19 can disrupt a child's ability to socialize or attend school, and kids can pass the infection to more vulnerable family or community members. As of February 2022, about 75% of children and adolescents have had COVID-19, according to the CDC.
When can my kid get a booster?
Most kids 5 and older are currently eligible for a single booster dose of Pfizer's COVID-19 vaccine at least five months after their second primary dose. Immunocompromised kids are eligible for their first booster at least three months after their last vaccine.
"Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness," Walensky said in a statement in May. "We must continue to increase the number of children who are protected."
A decision has not been made yet about boosters for children under 5.
Do I need to give consent for my child to get vaccinated?
Parents generally need to consent to children receiving medical care, including Pfizer's COVID-19 vaccine. This is especially true for younger children.
Tennessee's vaccine director, Michelle Fiscus, was fired in August, allegedly in part for sending out a memo detailing the state's "mature minor doctrine," which explains how minors may seek medical care without the consent of their parents.
My child has allergies. Can they get the vaccine?
Yes, though you might be asked to stick around the waiting room so health care providers can monitor them for (extremely rare) allergic reactions that can occur after any vaccination.
"If the child has a history of anaphylaxis or other severe allergies, then the observation time after the injection may be 30 minutes instead of 15," said Dr. Anne Liu, an infectious disease specialist with Stanford Hospital and Clinics and the Lucile Packard Children's Hospital.
Children who have been prescribed an EpiPen for any reason should bring it to their vaccine appointment, Liu added.
As with adults, children with an allergy to an ingredient in Pfizer's COVID-19 shouldn't take it. You can find a list of ingredients in Pfizer's vaccine for kids 5 to 11 on the FDA's fact sheet.
Can my child get their COVID-19 shot at the same time as other vaccines?
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.