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05/17/2022

FDA OKs Pfizer-BioNTech COVID-19 booster for 5 to 11 year olds

The FDA has authorized a single booster dose for individuals aged 5 to 11 years old at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine.
Sandra Levy
Senior Editor
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Today, the Food and Drug Administration amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single-booster dose for administration to individuals aged 5 to 11 years old at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine.

“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 Califf.

“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,” Califf said. “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. 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.” 

[Read more: Retailers begin offering Pfizer COVID-19 booster shots]

On Jan. 3, the FDA authorized the use of a single-booster dose of the Pfizer-BioNTech COVID-19 vaccine for administration to individuals aged 12 to 15 years old after completion of primary vaccination with the Pfizer-BioNTech COVID-19 vaccine. Today’s action expands the use of a single-booster dose of the vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 vaccine for use in individuals 5 years old and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals aged 16 years old and older.

“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, director of the FDA’s Center for Biologics Evaluation and Research.

“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,” Marks said. “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 five 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.”

[Read more: Pfizer, BioNTech Phase 2/3 trial data show COVID-19  vaccine is safe in 5 to 11 year olds]

The EUA for a single-booster dose of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years old is based on the FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization 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 seven to nine months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to 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 five months (range five to nine months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills and fever.

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