Novavax requests EMA approval for updated JN.1 Covid vaccine

Novavax has recently put forth a type II variation application to the European Medicines Agency (EMA) for approval of its updated COVID-19 vaccine, NVX-CoV2705, for those aged 12 and older. This submission is part of the company's effort to align with guidance from both the EMA and the World Health Organization to focus on the JN.1 lineage for the autumn of 2024.

According to findings from nonclinical studies, the Novavax JN.1 COVID-19 vaccine has shown a broad neutralizing response against JN.1 lineage viruses. This includes effectiveness against viruses with the F456L and R346T mutations, as well as the FLiRT and FLuQE variants. Additionally, the vaccine has demonstrated the ability to elicit strong Th1-biased CD4+ T cell responses to JN.1 lineage variants. NVX-CoV2705 specifically aims at the parent strain of the KP.2 and KP.3.2 lineages.

Once approved, Novavax intends to distribute the vaccine in unit-dose vials throughout the European Union. The company has also sought authorization from the US Food and Drug Administration (FDA) and is in discussions with other regulatory bodies worldwide to gain approval for its JN.1 COVID-19 vaccine.

NVX-CoV2705 represents an updated formulation of Novavax's original COVID-19 vaccine, NVX-CoV2373, and is specifically designed to target the JN.1 variant. The vaccine uses a protein-based technology to produce non-infectious copies of the SARS-CoV-2 spike protein, which helps prime the immune system to recognize and combat the virus. The inclusion of Novavax’s Matrix-M adjuvant is intended to enhance and extend the immune response.

One of the practical advantages of this vaccine is its storage requirements. It is provided as a ready-to-use liquid that can be stored at temperatures between 2° to 8°C, making it compatible with existing vaccine supply chains and cold storage facilities.

John Jacobs, President and CEO of Novavax, emphasized the company's efforts to offer a protein-based alternative to mRNA vaccines for COVID-19 vaccination this fall. Jacobs stated, “Our updated COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3.”

NVX-CoV2705 marks an evolution from Novavax's initial COVID-19 vaccine, providing a targeted approach against the evolving virus strains and aiming to offer a reliable alternative to current mRNA-based vaccines in the market. With approvals pending from regulatory bodies such as the EMA and FDA, Novavax aims to contribute significantly to the ongoing fight against COVID-19, ensuring that updated vaccines are available to address the circulating variants.