FDA Gives Emergency Nod To Novavax's Adjuvanted COVID-19 Booster Dose

The FDA has granted emergency use authorization to Novavax Inc's NVAX COVID-19 Vaccine to provide a first booster dose at least six months after completion of primary vaccination.
The FDA EUA decision was based on data from the Phase 3 Prevent-19 clinical trial and the U.K.-sponsored COV-BOOST trial.
Related: Novavax Prototype COVID-19 Vaccine Data Shows Benefit Against Variants.
Following a booster dose, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection in the Phase 3 trials.
Neutralizing antibodies also increased by 34- to 27-fold compared to pre-boost levels when boosted at eight or 11 months.
In the COV-BOOST trial, the Novavax COVID-19 Vaccine increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine (heterologous boosting).
Last month, the European Commission approved Novavax's Nuvaxovid COVID-19 vaccine as a homologous and heterologous booster for adults aged 18 and older.
Price Action: NVAX shares are up 0.38% at $18.55 on the last check Wednesday.