LONDON — Pfizer Inc. and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to incorporate little ones 12 to 15 years aged, in a move that could provide youthful and significantly less at-danger populations in Europe accessibility to the shot for the first time.
In a assertion Friday, the two prescription drugs explained their submission to the European Medicines Agency is primarily based on an highly developed examine in extra than 2,000 adolescents that showed their vaccine to be protected and helpful. The small children will go on to be monitored for for a longer period-time period protection and security for one more two decades.
BioNTech and Pfizer have beforehand asked for their emergency use authorization with the U.S. Food stuff and Drug Administration also be extended to small children 12 to 15 many years outdated.
German Health Minister Jens Spahn welcomed the news that the vaccine could possibly quickly get the inexperienced mild for more mature little ones.
“This can make a further authentic big difference to our vaccine campaign, if acceptance is granted,” he stated on the sidelines of a check out to a vaccine production plant in the German city of Reinbek.
The COVID-19 vaccine built by Pfizer and BioNTech was the 1st a person to be granted a greenlight by the EMA previous December, when it was licensed for any person 16 and more than throughout the 27-nation EU bloc.