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AAP publishes statement strongly discouraging off-label use of the COVID-19 vaccine for children under 12

With the recent approval of the Pfizer-BioNTech COVID-19 vaccine for ages 16 and older finalized by the U.S. Food and Drug Administration (FDA), clinicians are now able to legally administer the COVID-19 vaccine off-label to children 11 years and younger who are ineligible for an authorized vaccine.

However, in its recent statement, the American Academy of Pediatrics (AAP) strongly discouraged this practice.

With many differences in dose calculations and schedules between adults and children, Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, urges against the administration of the vaccine to children under 12 years based on experiences with the vaccine in older patients.

AAP President Dr. Lee Savio Beers advises clinicians to wait for the data from the clinical trials for the COVID-19 vaccine in children ages 11 years old and younger.

While the FDA is still considering full approval of the COVID-19 vaccine for ages 12-15, it is still available under emergency use authorization for this age group. The AAP strongly recommends all eligible adolescents to be vaccinated as soon as possible.

The AAP is also calling on the FDA to work aggressively to authorize a vaccine for ages 11 years and younger. With the delta variant spreading rapidly among unvaccinated people, as of Aug. 19, the AAP reported 180,000 new cases of COVID-19 among children and adolescents. Increasing the vaccination rates amongst those who are eligible now is important to protect children while the clinical trials are still underway.

Read the AAP’s full statement here.