Novavax Inc (NVAX)

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NEWS: Novavax Prepared to Deliver JN.1 Protein-based Non-mRNA COVID-19 Vaccine This Fall Consistent with U.S. FDA VRBPAC Recommendation

https://ir.novavax.com/press-releases/Novavax-Prepared-to-Deliver-JN-1-Protein-based-Non-mRNA-COVID-19-Vaccine-This-Fall-Consistent-with-U-S-FDA-VRBPAC-Recommendation

June 5, 2024

Today the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 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. The Committee acknowledged the importance of having a protein-based option available at the start of the vaccination season, alongside other alternatives. Novavax expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September this fall, pending authorization.

The Committee acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains, based upon data presented by all manufacturers, and the need to minimize confusion in making public health recommendations. Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for a range of 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-19.1,2

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).1,3,4 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).1 These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including to circulating forward drift variants.