Novavax 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.
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 authorisation from the US Food and Drug Administration (FDA) and is in discussions with other global regulatory bodies for the approval of its JN.1 Covid-19 vaccine.
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By GlobalData
NVX-CoV2705 is a modified formulation of Novavax’s original Covid-19 vaccine, NVX-CoV2373, and is designed to target the JN.1 variant.
It utilises a protein-based technology to produce non-infectious copies of the SARS-CoV-2 spike protein, which primes the immune system to recognise the virus. The inclusion of Novavax’s Matrix-M adjuvant aims to enhance and extend the immune response.
The vaccine is provided as a ready-to-use liquid and can be stored at temperatures between 2° to 8°C, which allows for the use of existing vaccine supply chains and cold storage facilities.
Novavax president and CEO John Jacobs stated: “Novavax is working closely with European markets seeking to offer a protein-based alternative to mRNA this fall for Covid-19 vaccination.
“Our updated Covid-19 vaccine is active against current circulating strains, including KP.2 and KP.3.”
