Updated Protein-based 2024-2025 Formula COVID-19 Vaccine Preps for Distribution

Novavax, Inc. today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. 

The submission aligns with guidance from the U.S. FDA, the European Medicines Agency, and the World Health Organization to target the JN.1 lineage during late 20204.

As discussed at the recent FDA meeting, targeting JN.1, the parent strain of the most common currently circulating SARS-CoV-2 virus variants has a public health benefit.

Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants.

"Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on June 14, 2024.

Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants. 

Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.2 Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.

Novavax intends to have doses in the U.S. for distribution by mid-July. Upon FDA authorization and U.S. CDC recommendation, Novavax is preparing to deliver to U.S. customers promptly. Novavax is also working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.