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.
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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.
Most COVID-19 vaccines approved by authorities around the world are for adults, who are at higher risk, but health officials believe vaccinating children of all ages will be critical to stopping the pandemic. Some research has shown that older children may play a role in spreading the virus.