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FDA approves COVID vaccines for children 5 and younger

The agency said it continues to monitor any risks associated with the vaccines

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The U.S. Food and Drug Administration (FDA) has given the go-ahead on emergency use of both the Moderna and the Pfizer-BioNTech COVID-19 vaccines in children down to 6 months of age. The agency said that its analysis of the vaccines' safety and efficacy was “rigorous and comprehensive,” adding that the benefits of using those vaccines outweigh any “known and potential risks.”

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children, and this action will help protect those down to 6 months of age.  As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA commissioner Robert M. Califf, M.D.

Timing is everything, and Moderna says the upside for younger school-age children is good. "Children vaccinated early this summer with a two-dose regimen will initiate protection as they return to school and daycare settings in the fall," the company said in its announcement.

How and when the two vaccines are administered vary a bit. For the Moderna vaccine, it should be administered in two doses, each a month apart. The Pfizer-BioNTech vaccine will require three doses – the first two area taken three weeks apart and the third eight weeks after the second dose.

Covering all risks

Much like it did earlier this year when it authorized a second booster dose for immunocompromised people, the FDA says the vaccines are also authorized for a third primary series dose at least one month following the second dose for those in that risk category.

The FDA said it also continues to monitor previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination. The agency reported that the risks it observed are highest in males 18 through 24 years of age for the Moderna vaccine and males 12 through 17 for the Pfizer-BioNTech vaccine, but that evidence shows there’s “rapid resolution” for those experiencing related symptoms with no impact on quality of life.

Both companies said that there are possible side effects for younger vaccine recipients. Moderna said the most commonly reported local symptom was injection site pain across all age groups, and that the most commonly reported systemic symptoms were headache and fatigue in older children and irritability in younger children.

Pfizer reported several side effects as well, including rash, itching, hives, swelling of the face, injection site pain, and tiredness.

Fact sheets for both the Pfizer vaccine and the Moderna vaccine are available for recipients and caregivers.

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