The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for Moderna's updated COVID-19 mRNA vaccine, Spikevax, which targets the SARS-CoV-2 variant JN.1. This decision paves the way for the vaccine's potential use in the European Union for the 2024-2025 autumn/winter vaccination season. The vaccine is designed for active immunization to prevent COVID-19 in individuals six months of age and older.
Clinical and Regulatory Landscape
The CHMP's recommendation is based on a comprehensive review of manufacturing and preclinical data, as well as existing clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's mRNA COVID-19 vaccines. The updated vaccine composition aligns with the EMA's Emergency Task Force (ETF) guidance from April 2024, which recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the upcoming vaccination campaign. The EMA confirmed this recommendation in July 2024.
"The CHMP's positive recommendation for our updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating our commitment to protecting citizens across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "As respiratory diseases increase during the winter months, it is crucial for people to protect themselves by getting vaccinated with an updated COVID-19 vaccine that provides enhanced neutralizing antibody responses to JN.1 and its descendant lineages."
Global Approvals and EU Tendering
Moderna has already received approval for its COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 in Japan, Taiwan, and the UK. In the U.S., Moderna has received approval for its COVID-19 vaccine targeting the KP.2 variant of SARS-CoV-2. Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies.
In the European Union, Moderna is participating in a tendering procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC).
Moderna's mRNA Platform
Moderna is leveraging its mRNA platform to develop therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases. The company's mRNA technology has enabled the rapid development of vaccines, including one of the earliest and most effective COVID-19 vaccines.
