Pfizer Inc. and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to include children 12 to 15 years old, in a move that could offer younger and less at-risk populations in Europe access to the shot for the first time.
In a statement Friday, the two pharmaceuticals said their submission to the European Medicines Agency 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.
Executive Director Emer Cooke received her #COVID19 vaccine today. 👍— EU Medicines Agency (@EMA_News) April 30, 2021
By expediting the development and approval of safe and effective treatments and vaccines, EMA is contributing to global efforts to save lives during the pandemic. #SafeVaccines pic.twitter.com/J3tg3omBmZ
BioNTech and Pfizer have previously requested their emergency use authorization with the U.S. Food and Drug Administration also be extended to children 12 to 15 years old.
German Health Minister Jens Spahn welcomed the news that the vaccine might soon get the green light for older children.
“This can make a further real difference to our vaccine campaign, if approval is granted,” he said on the sidelines of a visit to a vaccine manufacturing plant in the German town of Reinbek.
The COVID-19 vaccine made by Pfizer and BioNTech was the first one to be granted a greenlight by the EMA last December, when it was licensed for anyone 16 and over across the 27-nation EU bloc.