The FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least 5 months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. The Centers for Disease Control and Prevention (CDC) expanded eligibility of COVID-19 vaccine booster doses to everyone 5 years of age and older and now recommends that children ages 5 through 11 should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series.
“As cases increase across the country, a booster dose will safely help restore and enhance protection against severe disease,” the CDC notes. 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 a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age is effective in helping to prevent the most severe consequences of COVID-19 in children and older age groups.
The FDA granted this latest EUA based on the agency’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 EUA of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus 1 month after the booster dose was increased compared with before the booster dose. The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least 5 months (range, 5 to 9 months) after completing a two-dose primary series. The most commonly reported adverse effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills and fever.