Moderna will submit for Emergency Use Authorization with FDA

Moderna announced that it will submit for an Emergency Use Authorization with the U.S. FDA and an application for Conditional Marketing Authorization with the European Medicines Agency for its Covid-19 vaccine mRNA-1273. The company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification and/or Emergency Use Listing with the World Health Organization. Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. The company expects that the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will make a recommendation on immunization priorities. Moderna anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted. Shares of Moderna are up 10%, or $13.19, to $140.22 in premarket trading.