Moderna's and Pfizer's Covid-19 shots can now be given to children as young as 6 months old, making them eligible for vaccinations in the U.S.
The FDA decision comes after its committee of independent vaccine experts unanimously recommended the shots after weighing their safety and effectiveness during an all day meeting.
The FDA approved Pfizer's three-dose vaccine for children 6 months to 4 years old and Moderna's two-dose vaccine for children 6 months to 5 years old. Only children under the age of 5 are not eligible to receive vaccine. Parents have been waiting for the FDA to approve the vaccine for their children.
Moderna's vaccines were approved by the FDA on Friday. Pfizer's vaccine was the only one available for this group.
There is still one more step to go before vaccinations can begin. Guidelines for pharmacy and doctors' offices will be voted on by the committee of the Centers for Disease Control and Prevention. The CDC Director has to sign off on the guidelines before kids can get the shots.
The vaccinations are expected to start as soon as Tuesday. Every parent who wants to get their child vaccine should be able to do so within a few weeks, according to the Biden administration's Covid response.
State and local authorities can get 10 million Pfizer and Moderna doses.
The FDA takes longer to authorize the shots for infants through preschoolers than for other ages because they are a vulnerable group that requires special care to make sure the shots were safe and effective.
Pfizer and Moderna's vaccines for infants through preschoolers differ in the number of shots they use, the dose level and the eligibility age. Preliminary data shows that Pfizer's vaccine appeared to be more effective than Moderna's.
Children 6 months to 4 years of age are given Pfizer's vaccine. The shots are one tenth of what adults get. In 6-month to 2-year-olds, three shots were about 75% effective at preventing infections from omicron.
It is important for parents who choose Pfizer to make sure their children get the third shot. The two doses were only effective at preventing infections in children under 2 years old.
The vaccine is given to children 6 months to 5 years of age. Adults get one-fourth the level of the shots.
For kids 6 months to 2 years old, Moderna's vaccine was about 50% effective, and for kids 2 to 5 years old, it was 42% effective. The company expects the vaccine to protect against severe illness because the kids had higher levels of the vaccine than adults.
According to the FDA, pain at the injection site was the most common side effect of the vaccines. There were no cases of myocarditis, a type of heart inflammation, in Pfizer's or Moderna's trials.
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