Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization

FDA Authorization:
The FDA has granted emergency use authorization (EUA) for Novavax's updated COVID-19 vaccine, which targets the JN.1 variant and is intended for individuals aged 12 and older.

Vaccine Details:
The vaccine is a protein-based option, containing the Matrix M adjuvant, and is the only non-mRNA COVID-19 vaccine available in the U.S..

Distribution:
Pre-filled syringes of the vaccine will be distributed nationwide, available in thousands of locations including retail and independent pharmacies and regional grocers.

Clinical Data:
Non-clinical data suggest the vaccine induces broad neutralization responses against JN.1 lineage viruses, including those with FLiRT and FLuQE mutations.

Partnership:
Novavax has partnered with Sanofi, which will acquire rights to co-promote the vaccine globally and develop it in conjunction with its influenza vaccine, providing significant financial support to Novavax.