FDA authorizes COVID-19 vaccines for kids under 5, Moderna’s vaccine for children 6 through 17 years

The Food and Drug Administration (FDA) has authorized COVID-19 vaccines for children as young as 6 months old on Friday, clearing a key hurdle in expanding eligibility for the shots to 20 million babies, toddlers, and preschoolers.

The FDA also moved Friday to authorize Moderna’s vaccine for children 6 through 17 years old, after the company’s request to vaccinate these children had been stalled for months over concerns it might pose a larger risk of heart inflammation side effects in adolescents.

The Centers for Disease Control and Prevention must still sign off before kids under age 5 can start getting vaccinated, which could happen within days.

If recommended by the CDC, Moderna’s vaccine would offer the first alternative to the Pfizer shots that have been available in these older children for several months. The CDC’s advisers are expected to vote on that updated guidance next week.

“Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” FDA Commissioner Dr. Robert Califf said in a statement announcing the move.

The FDA’s decision comes after unanimous votes of support out of a daylong meeting Wednesday of the regulator’s outside advisers, the Vaccines and Related Biological Products Advisory Committee, which weighed submissions from Moderna as well as Pfizer and its partner BioNTech.

The FDA’s emergency use authorization is enough for shipments to begin around the country to facilities and health care providers who pre-ordered doses for the initial wave of shots. Those are expected to be delivered through the Juneteenth holiday weekend.

However, as with older age groups, federal supply agreements require vaccinators to wait for the CDC’s sign-off before administering shots formulated for younger children.

A panel of the CDC’s own advisers, the Advisory Committee on Immunization Practices, is scheduled to vote on Saturday. Once the CDC director formally greenlights vaccinations following the meeting, federal officials have said they expect many kids can start getting shots as soon as Tuesday, June 21.

Federal officials said providers in most jurisdictions — except for Florida — had pre-ordered doses out of the 10 million total shots that were made available; 2.5 million orders were received for Pfizer’s shots and 1.3 million for Moderna’s.