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FDA Officially Authorizes Pfizer, Moderna COVID-19 Vaccines for Emergency Use in Babies, Toddlers

The FDA on Friday (June 17) authorized two COVID-19 vaccines for emergency use in babies, toddlers and preschool-age children, setting the stage for the country’s youngest kids to begin receiving shots as soon as next week.

The agency’s action came two days after its independent advisory panel on vaccines unanimously voted to recommend EUAs for Moderna’s and Pfizer-BioNTech’s vaccines, which can be administered to children as young as six months.

In addition to authorizing the mRNA vaccines for the youngest children, the FDA authorized Moderna’s COVID-19 vaccine for children six to 17. For all ages, the FDA determined that a third dose of Moderna’s shot should be given to children with certain types of compromised immune systems at least one month after they receive their second shot. The Pfizer-BioNTech vaccine had already been authorized for children as young as five.

The CDC’s panel of expert advisers will consider whether to recommend the shots’ administration during meetings on Friday and Saturday. Once CDC Director Rochelle Walensky signs off on a recommendation, children are expected to begin receiving shots by Tuesday (June 21).

Children under 6 who receive the Moderna vaccine will get two 25-microgram doses four weeks apart. The Pfizer vaccine is two 3-microgram doses three weeks apart, followed by a third dose at least eight weeks later.

Real-world efficacy against the Omicron variant in the 6-month-to-5-year-old age group for Moderna’s vaccine ranged from 36% to 51% , and efficacy estimates were “generally consistent” with rates seen in observational studies of adults during the same variant waves, the FDA said.

Preliminary analysis of the Pfizer vaccine showed efficacy of 80% in kids under 5 against disease, though only 10 COVID-19 cases were reported among study participants before the data cutoff date in April, limiting confidence in that figure.

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