Moderna has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization of an updated formulation of the Spikevax mRNA COVID-19 vaccine, targeting SARS-CoV-2 variant JN.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six months or older. Following this positive opinion, the European Commission will take a decision authorising the use of Moderna’s updated COVID-19 vaccine for the autumn/winter 2024-2025 season.
In this sense, Stéphane Bancel, Chief Executive Officer of Modernasays that the CHMP’s positive recommendation for our updated mRNA COVID-19 vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating its commitment to protecting citizens across the European Union. He adds that as respiratory illnesses increase during the winter months, It is crucial that people protect themselves by getting vaccinated with an updated COVID-19 vaccine that provides enhanced neutralizing antibody responses against JN.1 and its descendant lineages.
Vaccine approval
The CHMP decision is based on a combination of manufacturing and preclinical data, as well as prior clinical, nonclinical and real-world evidence supporting the efficacy and safety of Moderna’s mRNA COVID-19 vaccines.. The updated composition of the vaccine is based on the EMA’s Emergency Task Force (ETF) indication in April 2024, which recommended that COVID-19 vaccines be updated to target the JN.1 family of omicron subvariants for the 2024-2025 vaccination campaign. The EMA confirmed this recommendation in July 2024.
Moderna has received approval for its mRNA COVID-19 vaccine targeting the SARS-CoV-2 JN.1 variant in Japan, Taiwan, and the United Kingdom. In the United States, Moderna has received approval for its COVID-19 vaccine targeting the SARS-CoV-2 variant KP.2. Other applications for authorization for Moderna’s updated COVID-19 vaccines against KP.2 or JN.1 are under review by other regulatory bodies. In the European Union, Moderna is participating in a tender procedure for mRNA COVID-19 vaccines by the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA).
