EU drug regulator evaluating Pfizer vaccine for youngsters

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

AMSTERDAM -- The European Union's drug regulator said Monday 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. In a statement 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. The companies' vaccine is currently approved for use in people ages 16 years and older. Extending that approval to the younger age group could offer younger and less at-risk populations in Europe access to the shot for the first time.