Section I.6 Product
I.6.1 The “Product” to be supplied by the contractor under this APA is a pandemic–preservative containing mRNA–based CVnCoV COVID–19 vaccine. More specifically, the mechanism of the technology of the vaccine will be an mRNA–based vaccine coding for the full length pre fusion conformation stabilised version of the full–length spike (S) protein of SARS–CoV– 2 virus.
II.6.2 An indicative specification of the Product is provided in Annex IV to this APA. However, due to the early stage of development of the Product, this specification is subject to change. The “final specification” of the Product will be determined by the contractors documentation of the Product as approved in the EU marketing authorisation. If a participating Member State should request delivery of the Product prior to the grant of the EU marketing authorisation and if contractor accepts such request (where the withholding of such acceptance is at the contractors discretion pursuant to Article I.7.1), the relevant specification of the Product will be determined by the documentation submitted by the contractor as approved in the temporary national authorisation granted by that participating Member State.
I.6.3 In the context of this APA, a “dose” of the Product refers to the amount of vaccine, including diluent, needed for one injection; this amount corresponds to [redacted content], the dose which is taken forward to the pivotal Phase III clinical trial.