Partners seek EUA for COVID-19 booster jab in kids aged five to 11
Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) have submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10µg booster dose of their COVID-19 jab for children aged five to 11 years of age.
The submission included data from the Phase II/III trial in children aged five through 11 years who received a booster dose approximately six months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10µg two-dose primary series, which was authorized under EUA for this age group in October 2021.
Data from the study demonstrated a strong immune response in this age group following a booster dose of the vaccine. There were no new safety signals reported.
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