July 19, 2024
In April 2024, the European Medicines Agency (EMA) issued a recommendation to modify the antigenic composition of the currently authorized COVID-19 vaccines to be used during the 2024-2025 vaccination campaign.
The EMA’s Emergency Task Force (ETF) recommended adapting the vaccines to target the Omicron subvariants JN.1 to ensure a better match against the dominant strain (JN.1) and emerging strains, and to increase the breadth of immunity against descendant lineages. This position aligns with the WHO recommendation issued on April 26, 2024.
During the plenary meeting in June, the Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of a Comirnaty vaccine adapted to the JN.1 subvariant. The European Commission’s decision was expedited on July 3, 2024. The Spikevax, Nuvaxovid, and
Bimervax vaccines targeting JN.1 are being evaluated by the CHMP.
The EMA/ETF strategy for COVID-19 vaccines is to ensure that updated vaccines can be manufactured and delivered in a timely manner and are capable of maintaining adequate protection against the dominant subvariant, recognizing that it is not possible to perfectly match the viral strains that will circulate in the fall.
Therefore, considering the available evidence, any alteration to the previously published ETF recommendation for the update of COVID-19 vaccines is currently not justified. Targeting JN.1 will facilitate timely vaccination campaigns in Europe after the summer to help reduce the burden of disease associated with COVID-19. All COVID-19 vaccines based on JN.1 or any subvariant of JN.1, such as KP2, will need marketing authorization before they can be made available in the European Union (EU).
The national authorities in the EU will ultimately make decisions regarding the vaccination campaigns for 2024 and 2025, taking into account the situation in their country.
The EMA will continue to monitor the situation as it evolves and will communicate as necessary.