BioNTech is set to request approval across the globe for use of its COVID-19 vaccine in children as young as five over the next few weeks and preparations for a launch are well on track, two of the biotech firm’s top executives told Der Spiegel.
“Already over the next few weeks we will file the results of our trial in five to 11 year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Chief Medical Officer Oezlem Tuereci told the weekly magazine.
She added final production steps were being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine, jointly developed with Pfizer. It is currently approved for adults and children over 12.
The raw trial data was now being prepared for a regulatory filing and “things are looking good, everything is going according to plan,” Chief Executive Ugur Sahin told Der Spiegel.