Amended emergency use authorization would include 12-15 year olds
Pfizer and BioNTech have requested amendments to the US emergency use authorization (EUA) of their Covid-19 vaccine (BNT162b2) to expand the use to adolescents 12 to 15 years of age.
The companies plan to request similar rulings by other regulatory authorities across the globe in the coming days. These requests are based on data from a Phase III trial in young adults 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100% efficacy and robust antibody response after vaccination with the Covid-19 vaccine. The results were released in March.
In the US, the Pfizer-BioNTech vaccine is currently authorized for emergency use in individuals age 16 and older.