Pfizer and BioNTech have forwarded a request to the European Medicines Agency to approve the use of their jointly developed coronavirus vaccine on children 12 to 15 years old.
The move could offer younger and less at-risk populations in Europe access to the shot for the first time, The Associated Press reported Friday.
The companies said in a statement Friday their submission is based on an advanced study of more than 2,000 adolescents that showed their vaccine to be safe and effective, AP reported. The children will be monitored for longer-term protection and safety for another two years, the drugmakers said.
German Federal Minister of Health Jens Spahn endorsed vaccinating older children.
“This can make a further real difference to our vaccine campaign, if approval is granted,” Spahn said, AP reported.
The Pfizer/BioNTech vaccine was the first to be approved by the EMA in December, when it was licensed for anyone aged 16 and older across the European Union.
In the U.S., the two companies have previously requested emergency-use authorization with the Food and Drug Administration to be extended to children 12 to 15 years old.