The European Union’s drug regulator said 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’s human medicines committee will carry out an accelerated assessment of data submitted by Pfizer and BioNTech and is expected to reach a decision in June, unless it requires extra information, the agency said, according to AP.
In a statement 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 children will continue to be monitored for longer-term protection and safety for another two years.
