Updated Protein-based, Non-mRNA COVID-19 Vaccine Awaits Europe's Authorization

Novavax, Inc. today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

The submission follows guidance from EMA and the World Health Organization to target the JN.1 lineage for the Fall 2024 season. 

Novavax's non-mRNA JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.2 

NVX-CoV2705 is an updated version of Novavax's authorized COVID-19 vaccine (NVX-CoV2373).

"Novavax is working closely with European markets seeking to offer a protein-based alternative to mRNA this fall for COVID-19 vaccination," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on June 24, 2024.

"Our updated COVID-19 vaccine is active against current circulating (SARS-CoV-2) strains, including KP.2 and KP.3."

Nonclinical data have demonstrated that Novavax's JN.1 COVID-19 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.

Novavax confirmed it intends to have its JN.1 COVID-19 vaccine in unit-dose vials available for immediate release in the European Union after approval.

Novavax has also filed with the U.S. FDA and is working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.