The companies filed a similar request in the United States earlier this month for the vaccine, which is already authorized for use in people from 16 years of age in both the United States and the European Union.
The submissions are based on positive data from a late-stage clinical trial that enrolled 2,260 participants aged 12 to 15, the companies said.
Pfizer Inc and partner BioNTech SE said on Friday they had applied to the European health regulator to extend the marketing authorization for their coronavirus vaccine for use in adolescents aged 12 to 15.
The companies filed a similar request in the United States earlier this month for the vaccine, which is already authorized for use in people from 16 years of age in both the United States and the European Union.
The submissions are based on positive data from a late-stage clinical trial that enrolled 2,260 participants aged 12 to 15, the companies said.
US Centers for Disease Control and Prevention director Rochelle Walensky told ABC News earlier this month that she expected the vaccine to be authorized for 12- to 15-year-olds by mid-May.
Comments
Comments are closed for this article.