European Union evaluating Pfizer vaccine for kids
AMSTERDAM (AP) - The European Union’s drug regulator says it has begun evaluating a request by Pfizer Inc. and BioNTech to extend approval of their coronavirus vaccine to include children ranging in age from 12 to 15.
The European Medicines Agency said Monday that its human medicines committee will carry out an accelerated assessment of data submitted by Pfizer and BioNTech. It is expected to reach a decision in June, unless it requires extra information.
On Friday the two pharmaceuticals said their request is based on an advanced study in more than 2,000 adolescents that showed their vaccine to be safe and effective. The companies’ vaccine is currently approved for use in people aged 16 years and older.
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