EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.
JN.1 differs from the XBB family targeted by previous updated vaccines and has now surpassed the XBB variants to become the most widely circulating variant worldwide.
In making its recommendation, the ETF consulted the World Health Organization (WHO), international partners and marketing authorisation holders for COVID-19 vaccines. The ETF also considered a wide range of data, including data on the evolution of the virus and data from animal studies on the effects of candidate vaccines targeting JN.1.
The evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.
Marketing authorisation holders should now contact EMA to discuss updates to the marketing authorisations of their vaccines. All marketing authorisation holders are expected to update the composition of their authorised vaccines in accordance with this recommendation.
Companies currently developing new COVID-19 vaccines not targeting JN.1 are also encouraged to contact EMA to discuss strategies for changing the composition of their vaccines.
National authorities in the EU will ultimately make decisions about vaccination campaigns for 2024 and 2025, taking into account the situation in their country.