FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years

FDA

17 May 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine, authorising the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine.

The emergency use authorisation for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age is based on FDA’s analysis of immune response data in a sub-set of children from the on-going randomised, placebo controlled trial that supported the October 2021 authorisation of the Pfizer-BioNTech COVID-19 vaccine primary series in this age group.

Read FDA press release 

Michael Wonder

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Michael Wonder

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Outcome , US , Vaccine , Paediatrics , COVID-19