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Pfizer, BioNTech seek EU approval for children’s Covid-19 vaccine

On Friday, Pfizer Inc and partner BioNTech SE said they had asked the European health regulator to extend the marketing authorization for their coronavirus vaccine for use in children aged 12 to 15.

Earlier this month, the companies had filed a similar appeal in the United States 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 companies said that the submissions are based on positive data from a late-stage clinical trial that enrolled 2,260 participants aged 12 to 15.

Rochelle Walensky, US Centers for Disease Control and Prevention director, told ABC News earlier this month that she anticipated the vaccine to be authorized for 12- to 15-year-olds by mid-May.


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