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Novavax Announces Expanded Agreement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes
GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing
About this update from Novavax, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has signed agreements with its partner, SK bioscience, for the manufacturing and supply of a version of the Novavax COVID-19 vaccine (NVX-CoV2373) containing Omicron variant and for the manufacture of the vaccine in prefilled syringes.\nThe companies signed an agreement for the technology transfer of Novavax' proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants including the Omicron BA.5 subvariant.\n\"Non-clinical data generated to date demonstrate that our COVID-19 vaccine offers broad immune responses including against circulating variants, such as Omicron BA.5,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We are accelerating our clinical program evaluating an Omicron BA.5 component to our vaccine and look forward to continuing to work with SK bioscience as an important manufacturing partner.\"\nIn addition, the companies have signed an agreement to manufacture and supply the Novavax COVID-19 vaccine in a prefilled syringe. SK bioscience will begin work to enable the manufacturing process for commercial supply of the vaccine in prefilled syringes in 2023.\nCurrently, SK bioscience manufactures drug substance for the vaccine. Novavax and SK bioscience also have a collaboration and licensing agreement under which SK bioscience exclusively commercializes the Novavax COVID-19 vaccine in South Korea, and with Novavax, jointly commercializes the vaccine in Vietnam and Thailand.\nAuthorized Use in the U.S.\nThe Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.\nIMPORTANT SAFETY INFORMATION\nContraindications\nDo not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.\nWarnings and Precautions\nManagement of Acute...