The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended issuing a marketing authorisation variation for the Comirnaty vaccine adapted to the Omicron XBB.1.5 variant for adults and children from 6 months of age. The European Commission has followed the recommendation and granted authorisation on 31 August 2023. In making its decision to recommend authorisation, the CHMP considered all available data on Comirnaty and the other adapted Comirnaty vaccine products, including safety, efficacy and immunogenicity data. Immunogenicity describes how well the vaccines trigger immune reactions specifically directed against SARS-CoV-2. In addition, the CHMP assessed new laboratory data showing the adapted vaccine's strong response against the Omicron XBB.1.5 variant and other Omicron subvariants of the virus that causes COVID-19.
The vaccine against the COVID-19 Omicron XBB variant was developed in line with the recommendations of the EMA bodies and the European Centre for Disease Prevention and Control (ECDC), as well as other international authorities and the World Health Organization (WHO). Omicron XBB.1.5 is closely related to other currently circulating Omicron subvariants. Previous data indicates that the adapted vaccine is not only effective against XBB.1.5, but also offers effective protection against other currently circulating variants and subvariants.
Comirnaty was first authorised in the EU in December 2020, and versions adapted to the strains BA.1 and BA.4-5 were authorised in September 2022.
Updated: 01.09.2023
