U.S. markets closed
  • S&P 500

    3,585.62
    -54.85 (-1.51%)
     
  • Dow 30

    28,725.51
    -500.10 (-1.71%)
     
  • Nasdaq

    10,575.62
    -161.89 (-1.51%)
     
  • Russell 2000

    1,664.72
    -10.21 (-0.61%)
     
  • Crude Oil

    79.74
    -1.49 (-1.83%)
     
  • Gold

    1,668.30
    -0.30 (-0.02%)
     
  • Silver

    19.01
    +0.30 (+1.62%)
     
  • EUR/USD

    0.9801
    -0.0018 (-0.19%)
     
  • 10-Yr Bond

    3.8040
    +0.0570 (+1.52%)
     
  • GBP/USD

    1.1166
    +0.0043 (+0.38%)
     
  • USD/JPY

    144.7200
    +0.2770 (+0.19%)
     
  • BTC-USD

    19,278.33
    -5.72 (-0.03%)
     
  • CMC Crypto 200

    443.49
    +0.06 (+0.01%)
     
  • FTSE 100

    6,893.81
    +12.22 (+0.18%)
     
  • Nikkei 225

    25,937.21
    -484.84 (-1.83%)
     

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

·1 min read
  • Novavax Inc (NASDAQ: 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.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.