Cambridge, July 3, 2023.
The application follows the recommendation of global public health and regulatory bodies to develop monovalent XBB.1.5 COVID-19 vaccines. The new vaccine will be available for the fall vaccination in ample and timely supply. Preliminary clinical data show that the company's XBB1.5 monovalent vaccine induces an immune response against XBB lineage viruses
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its COVID-19 vaccine. encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2."We are proud to announce this presentation of our updated vaccine against COVID-19 and to continue supporting the European Union in protecting citizens against COVID-19," said Stéphane Bancel, CEO of Moderna. "Our preliminary clinical trials demonstrated that our updated COVID-19 vaccine is effective in generating an immune response against current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and infection." 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 Center for Disease Prevention and Control (ECDC) and the EMA, which recommended that COVID-19 vaccines be upgraded to a monovalent composition XBB.1.5. This recommendation is consistent with that of other public health and regulatory bodies around the world, who recommend a monovalent XBB.1.5 composition. In addition, Moderna has generated preliminary clinical data from its XBB.1.5 monovalent vaccine candidate showing an immune response against sublineages descended from XBB such as XBB.1.5, XBB.1.16, and XBB.2.3.2. Moderna is in the process of submitting data to the regulatory agencies around the world to advance its updated COVID-19 vaccine in time for the fall/winter vaccination season and has recently filed applications with the Food
Contact Contact name: Luke Mircea-Willats Contact description: Sr. Director, International Communications
