FDA Authorizes Pfizer-BioNTech COVID-19 Booster for Children Aged 5 to 11 Years

The US Food and Drug Administration (FDA) on Tuesday May 17, granted emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine as a single booster dose to be administered to children aged 5 to 11 years at least 5 months after they have completed a primary vaccination series with the Pfizer-BioNTech COVID-19 vaccine, according to an FDA press statement.

The agency based its decision to grant the EUA on analysis of immune response data from a subset of children participating in the ongoing randomized placebo-controlled trial that was the basis of the October 2021 authorization of the primary series of Pfizer-BioNTech vaccine in the 5- to-11-year age group. Those children received a third 10 µg dose, the same dose given in the primary series, approximately 6 months after completing that series.

Antibody responses were evaluated in 67 participants who received a booster dose 7 to 9 months after completing a the 2-dose primary series.

Immunogenicity data from the study demonstrated a 6-fold increase in SARS-CoV-2 wild-type strain-neutralizing geometric mean titers (GMTs) 1 month after the booster compared with GMTs 1 month after the second dose. None of the children in the study had evidence of prior SARS-CoV-2 infection. A review of data from a subanalysis of 30 human immune sera showed that after a third, or booster, dose SARS-CoV-2 Omicron neutralizing antibody titers increased 36-fold.

“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 the agency statement.

“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 same press statement. “[…] 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.”

Safety of the single booster dose in this age group was evaluated among 400 children who received the third shot at least 5 months (range 5 to 9 months) after completing a 2-dose primary series. Overall, the vaccine was well tolerated. The adverse reactions most commonly reported included pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

For additional information, please view the updated fact sheet for the Pfizer-BioNTech COVID-19 vaccine.