The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) voted on 19 October 2022 to approve another type II variation of Spikevax. It was approved by the European Commission on 20 October 2022. 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 Spikevax bivalent Original/Omicron BA.4-5 contains both messenger RNA (mRNA) with the blueprint of the spike protein of the original SARS-CoV-2 (Wuhan) and mRNA with the spike protein blueprint of the Omicron variants BA.4 and BA.5, which is identical. The mRNAs are in a 1:1 mixing ratio (25 μg Wuhan mRNA + 25 μg BA.4/5 mRNA). The total amount is 50 µg mRNA per dose of vaccine, identical to the amount in the original Spikevax booster vaccine product.
The Omicron-adapted bivalent COVID-19 booster vaccine is produced analogously to the already authorised monovalent COVID-19 vaccine. The bivalent vaccine therefore does not differ with regard to its production, formulation, and composition from the authorised monovalent vaccines, with the exception of the mRNA composition.
The CHMP based its opinion on the available data on Spikevax and the recently approved adapted vaccine Spikevax bivalent Original/Omicron BA.1.
A clinical study showed that a booster dose of Spikevax bivalent Original/Omicron BA.1 induced a stronger immune response against the original SARS-CoV-2 strain and the Omicron subvariant BA.1 when administered as a booster vaccination for the originally authorised Spikevax vaccine.
The CHMP opinion on Spikevax 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 adapted vaccine can trigger an appropriate immune response.
Based on this data and the similar composition of the adapted vaccines, the CHMP concluded that Spikevax bivalent Original/Omicron BA.4-5 is expected to trigger a more effective immune response against the subvariants BA.4 and BA.5 than the originally authorised Spikevax vaccine. The safety profile of the vaccine is expected to be similar to that of Spikevax Original/Omicron BA.1 and Spikevax itself. Large amounts of data are available on the safety and efficacy of Spikevax.
The CHMP forwarded the opinion to the European Commission, which approved the additional type II variation on 20 October 2022.
Updated: 21.10.2022
