31/10/2022 (Agence Europe) – The European Medicines Agency (EMA) announced on 28 October the publication of clinical data supporting the authorisation of Comirnaty, the bivalent messenger RNA vaccine developed by Pfizer and BioNTech and suitable for use against the original SARS-CoV-2 strain and its sub-variant of concern BA.1. This publication is made under exceptional measures related to the Covid-19 pandemic. The vaccine was authorised by the European Commission on 1 September (see EUROPE 13013/14) on the basis of a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP). On 13 May, the Commission reached an agreement with Pfizer and BioNTech to reschedule vaccine deliveries and to integrate adapted vaccines into these deliveries. This has enabled the delivery of suitable vaccines to the Member States since September (see EUROPE 12951/20). More info at: https://aeur.eu/f/3uo (EV)