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Novavax (NVAX) Up 8% on FDA Nod for Updated COVID Booster Jab
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Novavax (NVAX - Free Report) announced that the FDA has granted emergency use authorization (“EUA”) to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), an updated version of its protein-based COVID-19 vaccine, in individuals aged 12 years and older.
Following the EUA, Novavax’s updated vaccine is the only non-mRNA vaccine option available to people in the United States.
The FDA’s decision is based on data from non-clinical studies wherein Novavax’s updated vaccine generated functional immune responses against multiple circulating Omicron-related sub-lineages, including XBB.1.5, BA.2.86 (also called ‘Pirola’), EG.5.1 (also called ‘Eris’), FL.1.5.1 (also called ‘Fornax’) and XBB.1.16.6.
The share price rose 8.2% on Tuesday following this news announcement. Though the updated mRNA-based COVID-19 vaccines marketed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) were granted approval by the FDA last month, the vaccine rollout has been slow. Unlike when the government handled the distribution and rollout, this is the first one through the commercial market (via retail pharmacies and physician offices). Several third-party reports have pointed out that this rollout has been hampered by logistical issues with distributors and insurance company platforms, thereby slowing the booster vaccines’ uptake.
This will likely benefit Novavax, whose updated COVID vaccine will be available nationwide in the coming days. With Novavax currently struggling with cash flow needs, a surge for COVID-19 vaccines will help the company generate additional cash resources to fund its business operations. In an SEC filing in August, management stated that they have sufficient cash to fund business for the next twelve months.
Novavax’s updated vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (“CDC”) last month.
Shares of Novavax have lost 25.4% year to date compared with the industry’s 17.6% decline.
Image Source: Zacks Investment Research
The updated COVID vaccines are supposed to be free through private insurance, Medicare and Medicaid plans. For those who are uninsured or underinsured, the CDC will temporarily provide free shots through its Bridge Access Program.
Novavax is one of the few companies which has an authorized vaccine for COVID-19 in the United States. However, the company faces stiff competition from Pfizer/BioNTech and Moderna, which currently dominate the COVID vaccination space. These companies have also updated their COVID vaccines, demonstrating robust immune responses against the newer coronavirus variants.
Last month, the FDA approved Moderna’s and Pfizer/BioNTech’s updated mRNA vaccines for use in individuals aged 12 years and older. However, both vaccines hold an edge over Novavax’s vaccine since they have been granted EUA for individuals aged six months through 11 years.
The Moderna and Pfizer/BioNTech vaccines are also approved for use in Europe for use in individuals aged six months and older. Novavax is working with the European health regulators to authorize its updated vaccine.
Image: Shutterstock
Novavax (NVAX) Up 8% on FDA Nod for Updated COVID Booster Jab
Novavax (NVAX - Free Report) announced that the FDA has granted emergency use authorization (“EUA”) to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), an updated version of its protein-based COVID-19 vaccine, in individuals aged 12 years and older.
Following the EUA, Novavax’s updated vaccine is the only non-mRNA vaccine option available to people in the United States.
The FDA’s decision is based on data from non-clinical studies wherein Novavax’s updated vaccine generated functional immune responses against multiple circulating Omicron-related sub-lineages, including XBB.1.5, BA.2.86 (also called ‘Pirola’), EG.5.1 (also called ‘Eris’), FL.1.5.1 (also called ‘Fornax’) and XBB.1.16.6.
The share price rose 8.2% on Tuesday following this news announcement. Though the updated mRNA-based COVID-19 vaccines marketed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) were granted approval by the FDA last month, the vaccine rollout has been slow. Unlike when the government handled the distribution and rollout, this is the first one through the commercial market (via retail pharmacies and physician offices). Several third-party reports have pointed out that this rollout has been hampered by logistical issues with distributors and insurance company platforms, thereby slowing the booster vaccines’ uptake.
This will likely benefit Novavax, whose updated COVID vaccine will be available nationwide in the coming days. With Novavax currently struggling with cash flow needs, a surge for COVID-19 vaccines will help the company generate additional cash resources to fund its business operations. In an SEC filing in August, management stated that they have sufficient cash to fund business for the next twelve months.
Novavax’s updated vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (“CDC”) last month.
Shares of Novavax have lost 25.4% year to date compared with the industry’s 17.6% decline.
Image Source: Zacks Investment Research
The updated COVID vaccines are supposed to be free through private insurance, Medicare and Medicaid plans. For those who are uninsured or underinsured, the CDC will temporarily provide free shots through its Bridge Access Program.
Novavax is one of the few companies which has an authorized vaccine for COVID-19 in the United States. However, the company faces stiff competition from Pfizer/BioNTech and Moderna, which currently dominate the COVID vaccination space. These companies have also updated their COVID vaccines, demonstrating robust immune responses against the newer coronavirus variants.
Last month, the FDA approved Moderna’s and Pfizer/BioNTech’s updated mRNA vaccines for use in individuals aged 12 years and older. However, both vaccines hold an edge over Novavax’s vaccine since they have been granted EUA for individuals aged six months through 11 years.
The Moderna and Pfizer/BioNTech vaccines are also approved for use in Europe for use in individuals aged six months and older. Novavax is working with the European health regulators to authorize its updated vaccine.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.