FDA authorizes Pfizer’s COVID-19 booster for children aged 5 to 11 years

The FDA on Tuesday authorized a booster shot of Pfizer and BioNTech’s COVID-19 vaccine for children aged 5 to 11 years.

The amended emergency use authorization means children can receive a booster dose of the vaccine at least 5 months after they complete the primary series.

Part of the reason for the authorization was the omicron wave, FDA Commissioner Robert M. Califf, MD, said.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” Califf said in a press release announcing the amended EUA.

“If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death,” Califf said.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said emerging data suggest that the vaccine’s effectiveness wanes following a second dose.

A real-word study published in MMWR in March demonstrated that the vaccine protects children aged 5 to 11 years, and Pfizer and BioNTech released data last month showing that a booster shot elicited a 36-fold increase in neutralizing titers against the omicron variant of SARS-CoV-2 with no new safety signals.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least 5 months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks said in the press release.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on June 8, 21 and 22 to discuss various EUA requests filed by Moderna and Pfizer-BioNTech for their pediatric COVID-19 vaccines.

Pfizer still has the only vaccine authorized for U.S. children or adolescents of any age.

Moderna has asked for EUAs covering children as young as age 6 months. Its EUA application for kids aged 12 to 17 years — originally filed in June 2021 — is still on hold because of concerns related to myocarditis.

As of May 11, the CDC reported that approximately 8.1 million children aged 5 to 11 years in the U.S. had received two doses of the Pfizer-BioNTech vaccine, representing just 28% of that population. An additional 1.7 million received one dose.

According to the AAP, more than 93,000 new pediatric COVID-19 cases were reported in the U.S. during the week ending May 12 — a 73% increase from 2 weeks prior. It was the fifth week in a row that cases increased among children in the U.S.

References:

AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published May 5, 2022. Accessed May 17, 2022.

AAP. Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published May 4, 2022. Accessed May 17, 2022.

Coronavirus (COVID-19) update: FDA announce tentative advisory committee meeting schedule regarding COVID-19 vaccines. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding. Published April 29, 2022. Accessed May 17, 2022.