Posted by Michael Wonder on 26 Sep 2022
Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorisation of Omicron BA.4/BA.5 adapted bivalent vaccine booster in children 5 through 11 years of age
26 September 2022 - Pfizer and BioNTech today announced they have completed a submission to the US FDA requesting Emergency Use Authorisation of a 10 µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.
The request for Emergency Use Authorisation of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1 adapted vaccine, non-clinical and manufacturing data from the companies’ 10 µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision.
