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Novavax's (NVAX) Protein-Based COVID Jab Gets EUA in the US
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Novavax (NVAX - Free Report) announced that the FDA has granted emergency use authorization (EUA) to its COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a primary two-dose regimen for use in adults aged 18 years and older.
Following the grant of EUA, Novavax’s vaccine has become the first protein-based COVID-19 vaccine authorized for use in the United States. This is also the first time that NVAX has received marketing authorization for a product in the United States.
The FDA’s decision comes a month after itsVaccines and Related Biological Products Advisory Committee (VRBPAC) recommended granting authorization for the use of Novavax’s vaccine in adults. The VRBPAC voted 21-0 (with one abstention) in favor of Novavax’s COVID vaccine for use in adults.
The decision to grant EUA is based on data from the pivotal phase III PREVENT-19 study on the vaccine, conducted in the United States and Mexico. Data from the study showed that the Novavax COVID-19 Vaccine, Adjuvanted was 90.4% effective in preventing COVID-19 infections. Per the FDA, the data from these studies suggest that the benefits of using the vaccine outweigh the risks.
Novavax will, however, be required to conduct clinical studies to further assess the risks of heart inflammation diseases like myocarditis and pericarditis, which were observed in some study participants who were administered Novavax’s vaccine.
Shares of Novavax have plunged 51.1% so far this year compared with the industry’s 20.6% decline.
Image Source: Zacks Investment Research
Following the EUA grant, the next step for Novavax is to procure a policy recommendation from the Centers for Disease Control and Prevention (CDC). If the CDC grants this recommendation, it will allow the company to execute the supply agreement with the U.S. government for 3.2 million doses of its COVID vaccine that was announced earlier this week.
Novavax’s COVID-19 vaccine is already authorized for use in more than 40 countries, including Australia, Canada, the European countries and India. NVAX is currently marketing two versions of NVX-CoV2373 — one in partnership with the Serum Institute of India under the trade name Covovax, and the other, produced by itself and marketed under the trade name Nuvaxovid.
Currently, the U.S. COVID-19 vaccine market is dominated by Moderna and Pfizer/BioNTech, which market mRNA-based vaccines. Per the CDC, as of Jul 6, 2022, around 71% of the population (aged 5 years and older) in the United States has already completed the primary regimen of a COVID vaccine developed by Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) or J&J. The EUA to Novavax COVID-19 Vaccine, Adjuvanted, will provide the unvaccinated population with an option to be vaccinated with a protein-based vaccine.
While Novavax is yet to tap the potential of the U.S. market, Moderna and Pfizer/BioNTech are currently way ahead of the curve. The vaccines developed by them dominate the U.S. market and are the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older. The vaccines are also authorized for use in individuals aged six months and above in the United States.
Like Novavax, Pfizer and BioNTech also reached an agreement with the U.S. government last month to deliver 105 million doses of their COVID-19 vaccine by this year. Upon receiving these doses, the U.S. administration will pay $3.2 billion to the companies. The deal also includes the supply of Pfizer/BioNTech’s Omicron-adapted COVID-19 vaccine, provided the FDA grants it EUA.
Image: Shutterstock
Novavax's (NVAX) Protein-Based COVID Jab Gets EUA in the US
Novavax (NVAX - Free Report) announced that the FDA has granted emergency use authorization (EUA) to its COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a primary two-dose regimen for use in adults aged 18 years and older.
Following the grant of EUA, Novavax’s vaccine has become the first protein-based COVID-19 vaccine authorized for use in the United States. This is also the first time that NVAX has received marketing authorization for a product in the United States.
The FDA’s decision comes a month after itsVaccines and Related Biological Products Advisory Committee (VRBPAC) recommended granting authorization for the use of Novavax’s vaccine in adults. The VRBPAC voted 21-0 (with one abstention) in favor of Novavax’s COVID vaccine for use in adults.
The decision to grant EUA is based on data from the pivotal phase III PREVENT-19 study on the vaccine, conducted in the United States and Mexico. Data from the study showed that the Novavax COVID-19 Vaccine, Adjuvanted was 90.4% effective in preventing COVID-19 infections. Per the FDA, the data from these studies suggest that the benefits of using the vaccine outweigh the risks.
Novavax will, however, be required to conduct clinical studies to further assess the risks of heart inflammation diseases like myocarditis and pericarditis, which were observed in some study participants who were administered Novavax’s vaccine.
Shares of Novavax have plunged 51.1% so far this year compared with the industry’s 20.6% decline.
Image Source: Zacks Investment Research
Following the EUA grant, the next step for Novavax is to procure a policy recommendation from the Centers for Disease Control and Prevention (CDC). If the CDC grants this recommendation, it will allow the company to execute the supply agreement with the U.S. government for 3.2 million doses of its COVID vaccine that was announced earlier this week.
Novavax’s COVID-19 vaccine is already authorized for use in more than 40 countries, including Australia, Canada, the European countries and India. NVAX is currently marketing two versions of NVX-CoV2373 — one in partnership with the Serum Institute of India under the trade name Covovax, and the other, produced by itself and marketed under the trade name Nuvaxovid.
Currently, the U.S. COVID-19 vaccine market is dominated by Moderna and Pfizer/BioNTech, which market mRNA-based vaccines. Per the CDC, as of Jul 6, 2022, around 71% of the population (aged 5 years and older) in the United States has already completed the primary regimen of a COVID vaccine developed by Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) or J&J. The EUA to Novavax COVID-19 Vaccine, Adjuvanted, will provide the unvaccinated population with an option to be vaccinated with a protein-based vaccine.
While Novavax is yet to tap the potential of the U.S. market, Moderna and Pfizer/BioNTech are currently way ahead of the curve. The vaccines developed by them dominate the U.S. market and are the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older. The vaccines are also authorized for use in individuals aged six months and above in the United States.
Like Novavax, Pfizer and BioNTech also reached an agreement with the U.S. government last month to deliver 105 million doses of their COVID-19 vaccine by this year. Upon receiving these doses, the U.S. administration will pay $3.2 billion to the companies. The deal also includes the supply of Pfizer/BioNTech’s Omicron-adapted COVID-19 vaccine, provided the FDA grants it EUA.
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Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.