FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children Ages 5 Through 11

Antibody levels against SARS-CoV-2 1 month after the booster dose were increased compared to before the booster dose in children 5 to 11 years of age.

Officials with the FDA have expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include the use of a single booster dose in children 5 through 11 years of age at least 5 months after the primary series.

The booster dose was authorized for individuals ages 12 through 15 years on January 3, 2022, and the new amendment expands the use of a single booster dose to a younger population. The primary COVID-19 vaccine from Pfizer and BioNTech has been authorized for use in individuals 5 years of age and older.

“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,” said FDA Commissioner Robert M. Califf, MD, in a press release. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.”

The EUA for a single booster dose in this age group is based on an FDA analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the original October 2021 authorization of the vaccine primary series in this pediatric population. Antibody responses were analyzed in 67 study participants who received a booster dose between 7 and 9 months after completing a 2-dose primary series and the antibody level against SARS-CoV-2 1 month after the booster dose was increased compared to before the booster dose.

The safety of a single booster dose in this age group was assessed in approximately 400 children who received the dose at least 5 months after completing a 2-dose primary series. The most commonly reported adverse effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

“The Pfizer-BioNTech COVID-19 vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. 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.”

REFERENCE

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years. News release. FDA; May 17, 2022. Accessed May 17, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose