The Food and Drug Administration on Friday authorized COVID-19 vaccines for emergency use in Americans as young as 6 months, a major step in launching a nationwide pediatric rollout as soon as Tuesday.
Regulators approved shots from Pfizer-BioNTech for persons aged 6 months through 4 years. Previously, the company’s vaccine was available to those 5 and older.
The FDA authorized Moderna’s vaccine for persons aged 6 months through 17 years, expanding the use of the drugmaker’s vaccine beyond adults.
The decision caps a lengthy wait for parents who were eager to vaccinate their youngest children. They say providing some level of protection against severe disease will help them pivot to normal activities.
“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,” FDA Commissioner Robert M. Califf said. “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.”
Pfizer proposed a three-dose regimen for children ages 6 months to 4 years that uses one-tenth of the adult dose. It released data in May that showed a preliminary efficacy of 80% after the third dose, though it was based on a small sample of symptomatic cases in the trial. A final analysis is pending.
Moderna has proposed a two-dose regimen for children ages 6 months to 5 years that uses one-fourth of the adult dose. It released data in late April that said the shots were 37% to 51% effective against symptomatic infection — a low level that is still on par with what adults would expect against the omicron variant after two doses.
It is studying the impact of a third dose in children, meaning the drugmaker could catch up to Pfizer’s version and provide similar levels of protection.
Advisers to the Centers for Disease Control and Prevention will meet on Friday and Saturday to discuss who should get the vaccines and offer an endorsement of the shots. CDC Director Rochelle Walensky will give a final sign-off over the weekend, clearing the way for administration following the Juneteenth holiday.
Uptake could be slow at first. Many parents are in “wait and see” mode and want other families to get the shots first, or don’t think young people will suffer bad outcomes from COVID-19 and might not get their children vaccinated.
Florida Gov. Ron DeSantis, a Republican, said his state will not use any of its resources to promote or distribute the shots. His state is the only one that did not pre-order shots for the youngest age group, prompting hospitals and pediatricians to complain they will have to seek the vaccines on their own, causing a delay.