The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) voted on 12 September 2022 to approve another type II variation of Comirnaty. It was approved by the European Commission on the same day. This amendment to the marketing authorisation applies to persons aged 12 years and over who have already received at least basic vaccination against COVID-19. The new adaptation was carried out in order to better combat the circulating SARS-CoV-2 variants.
The booster vaccine Comirnaty Original/Omicron BA.4-5 contains both messenger RNA (mRNA) with the blueprint of the spike protein of the original SARS-CoV-2 strain (Wuhan) and mRNA with the spike protein blueprint of the Omicron variants BA.4 and BA.5, which is identical. The mRNA types are in a 1:1 mixing ratio (15 μg Wuhan mRNA +15 μg BA.4/5 mRNA). As with the original Comirnaty vaccine product, the total amount is 30 μg mRNA per vaccine dose.
The Omicron-adapted bivalent COVID-19 booster vaccine is produced analogously to the already authorised monovalent COVID-19 vaccine. The bivalent vaccines therefore do not differ with regard to their production and formulation from the authorised monovalent vaccines, with the exception of the mRNA composition.
The CHMP based its opinion in particular on the clinical data available for Comirnaty Original/Omicron BA.1 clinical data available. Comirnaty Original/Omicron BA.4-5 and Comirnaty Original/Omicron BA.1 do contain mRNA from different Omicron subvariants, however they both belong to the Omicron variant and are therefore closely related. Otherwise, the vaccines have the same composition. Clinical studies with Comirnaty Original/Omicron BA.1 showed that the vaccine had a stronger immune response against the subvariant BA.1 than Comirnaty, while also being equally effective against the original Wuhan strain. The side effects were similar to those of Comirnaty. This has also been supported by data from investigational vaccines targeting other variants, which have also shown similar safety profiles and predictable immune responses against their corresponding strains.
The CHMP opinion on Comirnaty Original/Omicron BA.4-5 is also based on quality and manufacturing process data confirming that the product complies with EU quality standards. In addition, immunogenicity data (the ability of the vaccine to trigger an immune response) from non-clinical laboratory studies indicated that the vaccine Comirnaty Original/Omicron BA.4-5 induces an appropriate immune response against the Coronavirus variants whose components it contains.
Based on all this data, it is expected that Comirnaty Original/Omicron BA.4-5 triggers a stronger immune reaction ("superior") against the subvariants BA.4 and BA.5 as Comirnaty. The safety profile of the vaccine is expected to be similar to that of Comirnaty Original/Omicron BA.1 and Comirnaty itself. Large amounts of data are available on the safety and efficacy of Comirnaty.
Clinical trials with Comirnaty Original/Omicron BA.4-5 are still ongoing. The CHMP will evaluate the clinical data once it is available.
Updated: 13.09.2022
