Novavax submits application to EMA for updated JN.1 COVID-19 vaccine

Novavax announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency for its JN.1 COVID-19 vaccine for individuals aged 12 and older. The submission is in line with guidance from EMA and the World Health Organization to target the JN.1 lineage this fall. Novavax intends to have its vaccine in unit-dose vials available for distribution in the European Union for immediate release post-approval. Novavax has also filed with the U.S. FDA and is working with other regulatory authorities globally on authorization or approval of its JN.1 COVID-19 vaccine.