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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLarge CapNewsHealth CareSmall CapGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!