Moderna, Inc. (NASDAQ:MRNA) today announced that the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1., for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.
In April 2024, the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) issued guidance recommending the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.
Regulatory applications for Moderna’s updated COVID-19 vaccine are under review by regulatory agencies worldwide, with decisions anticipated in the coming weeks.
