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Novavax (NVAX) Receives FDA Nod for COVID-19 Booster Jab
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Novavax (NVAX - Free Report) 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 - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) 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.
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.
Image: Shutterstock
Novavax (NVAX) Receives FDA Nod for COVID-19 Booster Jab
Novavax (NVAX - Free Report) 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 - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) 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.
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. 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.