JN.1 Protein-based Non-mRNA COVID-19 Vaccine Prepares for September Delivery

The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted today to recommend that COVID-19 vaccines be updated to a monovalent JN.1-lineage composition for 2024-2025 and expressed a preference for the JN.1 strain.

As of June 5, 2024, Novavax Inc. stated in a press release that, pending authorization, it expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September 2024.

Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for various JN.1 descendant viruses, including KP.2 and KP.3.

'We believe updating to the JN.1 lineage or JN.1, as recommended by the World Health Organization and the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19,' wrote the company.

'Our most recent nonclinical data have demonstrated that our JN.1 vaccine candidate induces broad neutralization responses to JN.1 lineage viruses including those with the F456L mutation (e.g., JN.1.16), the R346T mutation (e.g., JN.1.13.1), to “FLiRT” variants that contain both mutations such as KP.2, currently the most common circulating variant in the U.S., and to “FLuQE” variants that are increasing in circulation (e.g., KP.3).'

'Our JN.1 vaccine candidate also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants, including those containing the F456L, R346T, and FLiRT mutations (e.g., KP.2).'

'These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including circulating forward drift variants.'

Based on data presented by vaccine manufacturers today, the VRBPAC acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains and the need to minimize confusion in making public health recommendations.

As of June 2024, Novavax's vaccine is the only protein-based, non-mRNA vaccine available in the U.S. Novavax vaccines have been offered by most pharmacies in the U.S.