U.S. Markets open in 8 hrs 56 mins
  • S&P Futures

    4,032.25
    -0.25 (-0.01%)
     
  • Dow Futures

    33,783.00
    -2.00 (-0.01%)
     
  • Nasdaq Futures

    11,944.25
    -23.75 (-0.20%)
     
  • Russell 2000 Futures

    1,894.60
    +1.10 (+0.06%)
     
  • Crude Oil

    77.57
    -0.33 (-0.42%)
     
  • Gold

    1,936.40
    -2.80 (-0.14%)
     
  • Silver

    23.74
    +0.01 (+0.03%)
     
  • EUR/USD

    1.0846
    -0.0011 (-0.0976%)
     
  • 10-Yr Bond

    3.5510
    -3.5180 (-100.00%)
     
  • Vix

    19.94
    -18.51 (-100.00%)
     
  • GBP/USD

    1.2344
    -0.0010 (-0.0839%)
     
  • USD/JPY

    130.2770
    -0.0810 (-0.0621%)
     
  • BTC-USD

    22,871.85
    -817.29 (-3.45%)
     
  • CMC Crypto 200

    519.05
    -18.83 (-3.50%)
     
  • FTSE 100

    7,784.87
    +19.72 (+0.25%)
     
  • Nikkei 225

    27,376.48
    -56.92 (-0.21%)
     

Novavax (NVAX) Receives FDA Nod for COVID-19 Booster Jab

Novavax NVAX announced that the FDA expanded the emergency use authorization (EUA) granted to Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older.

Following the FDA decision, Novavax’s COVID vaccine can now be administered as a booster dose, irrespective of whether or not the primary vaccine regimen series was completed with NVX-CoV2373. The EUA allows the vaccine to be administered to adults who are not suited to receiving an mRNA-based bivalent developed by Moderna MRNA and Pfizer PFE/BioNTech BNTX or those adults who want to be administered with Novavax’s COVID vaccine.

Novavax’s COVID-19 Vaccine, Adjuvanted, has also been endorsed by the Centers for Disease Control and Prevention (“CDC”) for use as a booster dose in adults.

Novavax’s protein-based vaccine has been granted EUA as a primary regimen in adults and adolescents aged 12 years and older as a two-dose primary regimen. Nevertheless, most of the U.S. population has already been inoculated with a primary regimen of either Moderna or Pfizer/BioNTech’s COVID vaccine.

The latest label expansion will enable Novavax to target a larger segment of the adult population who have already completed a primary vaccination series but are yet to receive a booster dose. Per CDC estimates, nearly 50% of the adult population in the United States has yet to receive their first booster dose.

The FDA decision and CDC endorsement are based on data from the late-stage PREVENT-19 study and mid-stage COV-BOOST study conducted in the United States and the U.K., respectively. Data from these studies showed that a booster dose of the vaccine generated increased immune responses by 34- to 27-fold compared with the data observed in pre-boost levels. The vaccine also induced a robust antibody response when used as a heterologous booster dose.

Shares of Novavax have plunged 87.5% so far this year compared with the industry’s 25.0% decline.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

Last month, the European Commission (EC) expanded its conditional marketing authorization (CMA) for Novavax’s COVID-19 vaccine to allow its use as a heterologous/homologous booster dose in adults aged 18 years and older in the European Union (EU).

Following the EUA expansion to Novavax’s vaccine, share prices of Moderna and BioNTech were down by almost 8% on Oct 19. The EUA expansion to Novavax’s vaccine gives the U.S. population more options as to which booster vaccine they would like to get administered. Unlike Pfizer, which already has a portfolio of marketed drugs and therapies, Moderna and BioNTech are entirely dependent on COVID vaccine sales for revenues that are likely to decline in the next year as the impact of the pandemic recedes rapidly.

Novavax, Inc. Price

 

Novavax, Inc. Price
Novavax, Inc. Price

Novavax, Inc. price | Novavax, Inc. Quote

 

Zacks Rank

Novavax currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Moderna, Inc. (MRNA) : Free Stock Analysis Report
 
Novavax, Inc. (NVAX) : Free Stock Analysis Report
 
BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research