Novavax Seeks FDA Emergency Use Nod For Its COVID-19 Vaccine Booster

  • Novavax Inc NVAX has submitted an application to the FDA for Emergency Use Authorization (EUA) for its protein-based COVID-19 vaccine as a homologous and heterologous booster in adults aged 18 and older.
  • This application is supported by data from Novavax's Phase 3 PREVENT-19 trial conducted in the U.S. and Mexico and from the UK-sponsored COV-BOOST Phase 2 trial. 
  • As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine.
  • Related: Novavax Q2 Results Trail Street Expectations, Slashes FY22 Outlook By 50%.
  • The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine induced a significant antibody response when used as a heterologous third booster dose.
  • In the PREVENT-19 trial, following the booster, local and systemic reactions had a median duration of approximately two days. 
  • Price Action: NVAX shares are up 2.72% at $42.60 during the premarket session on the last check Monday.
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