Novavax today announced that the European Medicines Agency has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine to the European Union (EU). This variation approval enables Novavax to manufacture product for the EU from two major vaccine suppliers – SK bioscience and the Serum Institute of India.
SK bioscience currently manufactures drug substance and drug product of Nuvaxovid for the South Korean market and will now manufacture drug substance for the EU as well.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.