COVID-19 Vaccine for Persons Aged 12 and Above – Evaluation Procedure for the Marketing Authorisation Extension of Comirnaty has now Started
The assessment of the application for an extension of the marketing authorisation for use of the mRNA-COVID-19 vaccine Comirnaty from BioNTech in children and adolescents aged 12 to 15 years was started at the European Medicines Agency (EMA) on 3 May 2021.
The Committee for Medicinal Products for Human Use (CHMP) at the EMA will perform an accelerated evaluation of the data submitted by BioNTech. These data include a major on-going clinical trial on adolescents of 12 years and over. The results are important for a decision as to whether the extension of the indication will be recommended. An opinion by the CHMP is expected in June 2021. This will be followed by the final legally binding decision from the European Commission as to whether an extension of the marketing authorisation will be granted. This decision will then apply to all EU member states.
Comirnaty was authorised in the EU in December 2020 for persons as from 16 years of age.