Moderna submits regulatory application to the European Medicines Agency for its updated COVID-19 vaccine for the XBB.1.5 sublineage of SARS-CoV-2.

"We are proud to announce this filing for our updated COVID-19 vaccine and continue to support the European Union in protecting citizens against COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our preliminary clinical testing showed that our updated COVID-19 vaccine is effective in generating an immune response against the current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and hospitalization. We look forward to working with the EMA to bring our updated vaccine to people across the European Union."

The application is based on guidance from the European Centre for Disease Prevention and Control (ECDC) and the EMA, which recommended that COVID-19 vaccines be updated to a monovalent XBB.1.5 composition. This aligns with other regulators and global public health agencies recommending a monovalent XBB.1.5 composition. Additionally, Moderna has generated preliminary clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.

Moderna is in the process of submitting data to regulators worldwide to advance its updated COVID-19 vaccine in time for the autumn/winter vaccination season and has recently filed with the FDA, Health Canada, and other health authorities.