has submitted a type II variation application with the European Medicines Agency (EMA) seeking approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above. The company’s filing for a variation of existing marketing authorisation aligns with guidance from the EMA and the World Health Organization to update vaccines to target the JN.
1 lineage for autumn 2024. The gold standard of business intelligence. According to nonclinical studies, the Novavax JN.
1 Covid-19 vaccine elicited a broad neutralising response against JN.1 lineage viruses, including those with the F456L and R346T mutations and the FLiRT and FLuQE variants. The vaccine also generates robust Th1-biased CD4+ T cell responses to JN.
1 lineage variants. NVX-CoV2705 specifically targets the parent strain of the KP.2 and KP.
3.2 lineages. Novavax aims to make the vaccine available in unit-dose vials for distribution within the European Union on receipt of approval.
The company has also sought (FDA) and is in discussions with other global regulatory bodies for the approval of its JN.1 Covid-19 vaccine. Access the most comprehensive Company Profiles on the market, powered by GlobalData.
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