Pfizer: FDA clears booster dose for 5-11 year olds
(CercleFinance.com) - Today Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has extended the emergency use authorization (EUA) for their Covid vaccine in 5-11 year olds to include the booster dose.
The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10 µg dose of Pfizer-BioNTech COVID-19 vaccine.
To date, over 8 million children aged 5-11 years have received the first two injections of the Pfizer/BioNTech serum in the US.
The expanded EUA is based on data from the Phase 2/3 trial, which showed that a booster dose of Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this clinical age group, generating neutralising antibodies to the Omicron variant.
The third dose was well tolerated, with a safety profile similar to the two-dose primary immunisation, Pfizer added.
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