Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking to amend the emergency use authorisation of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.
The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an on-going basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
